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Trial record 9 of 52 for:    LENALIDOMIDE AND Leukemia AND Acute Myeloid Leukemia

Azacitidine and Lenalidomide for Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01016600
Recruitment Status : Completed
First Posted : November 19, 2009
Results First Posted : September 7, 2015
Last Update Posted : September 7, 2015
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia, Myeloid, Acute
Interventions Drug: Lenalidomide
Drug: Azacitidine
Enrollment 31
Recruitment Details  
Pre-assignment Details 31 participants were enrolled but only 30 participants started treatment and completed treatment.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Phase II
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Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 25 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 50 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Period Title: Overall Study
Started 9 4 6 12
Completed 8 4 6 12
Not Completed 1 0 0 0
Reason Not Completed
Did not start treatment             1             0             0             0
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Phase II Total
Hide Arm/Group Description

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 25 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 50 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Total of all reporting groups
Overall Number of Baseline Participants 9 4 6 12 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants 4 participants 6 participants 12 participants 31 participants
70
(64 to 74)
67.5
(63 to 77)
75.5
(65 to 81)
72
(65 to 88)
72
(63 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 4 participants 6 participants 12 participants 31 participants
Female
6
  66.7%
1
  25.0%
3
  50.0%
4
  33.3%
14
  45.2%
Male
3
  33.3%
3
  75.0%
3
  50.0%
8
  66.7%
17
  54.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 4 participants 6 participants 12 participants 31 participants
9 4 6 12 31
1.Primary Outcome
Title Phase I Only - Maximum Tolerated Dose (MTD) as Measured by Dose-limiting Toxicities (DLTs)
Hide Description
  • The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle.
  • Hematologic DLT is as a persistent bone marrow aplasia with ≤ 10 % cellularity, which persists for > 60 days from the start of a chemotherapy cycle.
  • Non-hematologic DLT is defined as any Grade 3 or Grade 4 non-hematologic toxicity that occurs during the first cycle with the specific exceptions of nausea, vomiting, anorexia, weight loss, infections or electrolyte abnormalities attributable to any other cause. Grade 3 triglycerides will be considered a DLT only for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy.
Time Frame Completion of the phase I portion of study (approximately 1 year and 4 months)
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Hide Analysis Population Description
(1) participant in Cohort 1 did not start treatment. The Phase II cohort was not analyzed because this was a Phase I outcome only.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Phase II
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Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 25 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 50 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Overall Number of Participants Analyzed 8 4 6 0
Measure Type: Number
Unit of Measure: dose-limiting toxicities
1 0 0
2.Primary Outcome
Title Phase I Only - Maximum Tolerated Dose (MTD)
Hide Description
  • The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle.
  • Hematologic DLT is as a persistent bone marrow aplasia with ≤ 10 % cellularity, which persists for > 60 days from the start of a chemotherapy cycle.
  • Non-hematologic DLT is defined as any Grade 3 or Grade 4 non-hematologic toxicity that occurs during the first cycle with the specific exceptions of nausea, vomiting, anorexia, weight loss, infections or electrolyte abnormalities attributable to any other cause. Grade 3 triglycerides will be considered a DLT only for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy.
Time Frame Completion of the phase I portion of study (approximately 1 year and 4 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I Cohort
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Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 25 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: mg/m^2
75
3.Primary Outcome
Title Phase II Only - Complete Remission Rate (CRm + CRi) in Participants With Untreated AML ≥60 Years of Age
Hide Description
  • Morphologic complete remission (CRm): Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment.
  • Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.
Time Frame Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Cohort 1, 2, and 3 were not analyzed for this outcome as it is a Phase II outcome measure only. (3) participants in Phase II cohort were not evaluable for response because they did not complete cycle 1.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Phase II
Hide Arm/Group Description:

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 25 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 50 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Overall Number of Participants Analyzed 0 0 0 9
Measure Type: Number
Unit of Measure: percentage of participants
22
4.Secondary Outcome
Title Response Rate (CRm + CRc + CRi + PR)
Hide Description
  • Response rate (CRm + CRc + CRi + PR)
  • CRm = morphologic complete remission
  • CRc = cytogenetic complete remission
  • CRi = morphologic complete remission with incomplete blood count recovery
  • PR = partial remission
Time Frame Median number of cycles completed [3 cycles (12 weeks) full range (1 (4 weeks)-17 (68 weeks))]
Hide Outcome Measure Data
Hide Analysis Population Description
(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response. (1) participant in Cohort one had both CRm and CRc.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Phase II
Hide Arm/Group Description:

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 25 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 50 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Overall Number of Participants Analyzed 5 3 6 9
Measure Type: Number
Unit of Measure: participants
CRm 1 0 1 1
CRc 1 0 0 0
CRi 1 1 1 1
PR 2 0 2 5
5.Secondary Outcome
Title Morphologic Leukemia-free State
Hide Description Defined as < 5% blasts on the BM aspirate with spicules and a count of >200 nucleated cells and no blasts with Auer rods, and no persistent extramedullary disease.
Time Frame Median number of cycles completed [3 cycles (12 weeks) full range (1 (4 weeks)-17 (68 weeks))]
Hide Outcome Measure Data
Hide Analysis Population Description
(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Phase II
Hide Arm/Group Description:

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 25 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 50 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Overall Number of Participants Analyzed 5 3 6 9
Measure Type: Number
Unit of Measure: participants
2 1 2 2
6.Secondary Outcome
Title Morphologic Complete Remission Rate (CRm)
Hide Description Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.
Time Frame Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Phase II
Hide Arm/Group Description:

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 25 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 50 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Overall Number of Participants Analyzed 5 3 6 9
Measure Type: Number
Unit of Measure: participants
1 0 1 1
7.Secondary Outcome
Title Cytogenetic CR (CRc) Rate
Hide Description Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells).
Time Frame Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Phase II
Hide Arm/Group Description:

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 25 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 50 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Overall Number of Participants Analyzed 5 3 6 9
Measure Type: Number
Unit of Measure: participants
1 0 0 0
8.Secondary Outcome
Title CR With Incomplete Blood Counts Rate
Hide Description Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.
Time Frame Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Phase II
Hide Arm/Group Description:

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 25 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 50 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Overall Number of Participants Analyzed 5 3 6 9
Measure Type: Number
Unit of Measure: participants
1 1 1 1
9.Secondary Outcome
Title Partial Remission Rate (PR)
Hide Description Requires that the criteria for complete remission be met with the following exceptions: decrease of >50% in the percentage of blasts to 5-25% in the BM aspirate. A value of < 5% blasts in BM with Auer rods is also considered a partial remission.
Time Frame Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Phase II
Hide Arm/Group Description:

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 25 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 50 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Overall Number of Participants Analyzed 5 3 6 9
Measure Type: Number
Unit of Measure: participants
2 0 2 5
10.Secondary Outcome
Title Overall Survival
Hide Description Defined as the date of first dose of study drug to the date of death from any cause.
Time Frame Until death - median follow-up 4.6 months (full range (0.3-31.4 months))
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Phase II
Hide Arm/Group Description:

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 25 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 50 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Overall Number of Participants Analyzed 8 4 6 12
Median (Full Range)
Unit of Measure: months
4.2
(0.7 to 31.4)
4.5
(0.7 to 10.6)
8.9
(1.8 to 14.8)
4.3
(0.8 to 31.0)
11.Secondary Outcome
Title Event Free Survival
Hide Description Defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, or death due to any cause.
Time Frame Until death - median follow-up 4.6 months (full range (0.3-31.4 months))
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Phase II
Hide Arm/Group Description:

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 25 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 50 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Overall Number of Participants Analyzed 8 4 6 12
Median (Full Range)
Unit of Measure: months
3.8
(0.3 to 19.7)
3.4
(0.6 to 6.4)
7.8
(1.8 to 14.8)
2.9
(0.8 to 25.6)
12.Secondary Outcome
Title Time to Progression (TTP)
Hide Description Defined as the interval from the date of the first dose of study drug to the date of progressive disease.
Time Frame Until progressive disease - median follow-up 4.6 months (full range (0.3-31.4 months))
Hide Outcome Measure Data
Hide Analysis Population Description
(2) cohort 1 participants were not evaluable for this outcome measure because (1) was removed for DLT & (1) withdrew from study. (2) phase II participants were not evaluable because both were removed from study in the first cycle for adverse events.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Phase II
Hide Arm/Group Description:

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 25 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 50 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Overall Number of Participants Analyzed 6 4 6 10
Median (Full Range)
Unit of Measure: months
5.7
(0.3 to 19.7)
3.4
(0.6 to 6.4)
7.8
(1.8 to 14.8)
3.7
(0.9 to 25.6)
13.Secondary Outcome
Title Relapse Free Survival (RFS)
Hide Description This is determined only for patients achieving a complete remission. Defined as the interval from the date of first documentation of a leukemia free state to date of recurrence or death due to any cause.
Time Frame Until death - median follow-up 4.6 months (full range (0.3-31.4 months))
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Phase II
Hide Arm/Group Description:

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 25 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 50 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Overall Number of Participants Analyzed 2 1 2 2
Median (Full Range)
Unit of Measure: months
12.0
(6.2 to 17.7)
1.4
(1.4 to 1.4)
4.9
(3.2 to 6.7)
12.2
(1.1 to 23.2)
14.Secondary Outcome
Title Duration of CR for Complete Responders
Hide Description [Not Specified]
Time Frame Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
(6) participants in Cohort 1, (3) participants in Cohort 2, (4) participants in Cohort 3, and (10) participants in Phase II did not have a complete response and are not evaluable for this outcome.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Phase II
Hide Arm/Group Description:

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 25 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 50 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Overall Number of Participants Analyzed 2 1 2 2
Median (Full Range)
Unit of Measure: months
10.9
(6.2 to 15.6)
1.4
(1.4 to 1.4)
4.95
(3.2 to 6.7)
12.15
(1.1 to 23.2)
15.Secondary Outcome
Title Toxicity Profile (Grade 3/4 Toxicities)
Hide Description AML ≥18 years or untreated AML ≥60 years
Time Frame 30 days after completion of treatment (median follow-up was 12 weeks (range 8-72 weeks))
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Phase II
Hide Arm/Group Description:

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 25 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 50 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Overall Number of Participants Analyzed 8 4 6 12
Measure Type: Number
Unit of Measure: participants
Anemia 3 0 0 4
Febrile neutropenia 4 1 3 8
Otitis mastoditis - worsening 1 0 0 0
Diarrhea 1 0 2 0
Nausea 1 0 0 1
Vomiting 2 0 0 2
Dental carries 1 0 0 0
Fatigue 1 0 4 4
Sepsis 1 0 2 1
Bronchial infection 1 0 0 0
Bacteremia 2 0 1 0
Lung infection 3 0 2 9
Skin infection 1 2 2 2
Activated partial thromboplastin time prolonged 1 0 0 0
Blood bilirubin increased 2 0 2 3
Creatinine increased 1 0 1 0
Neutrophil count decreased 7 0 2 2
Platelet count decreased 4 2 3 6
White blood cell count decreased 7 1 4 10
Lymphocyte count decreased 5 1 1 2
Dehydration 2 0 0 3
Hypernatremia 1 0 0 0
Hypocalcemia 1 0 1 0
Hypophosphatemia 4 0 3 6
Back pain 1 0 0 0
Generalized muscle weakness 2 0 1 2
Pain in extremity 1 0 0 1
Leukemia vasculitis left calf 1 0 0 0
Acute kidney injury 1 0 1 0
Dyspnea 3 2 1 2
Epistaxis 1 0 0 0
Productive cough 1 0 1 0
Pulmonary edema 1 0 0 0
Rash maculo-papular 1 0 1 1
Skin ulceration 1 0 0 0
Hypotension 3 0 1 1
Constipation 0 1 0 0
Edema limbs 0 1 0 1
Catheter related infection 0 1 1 1
Alanine aminotransferase increased 0 1 0 1
INR increased 0 1 0 0
Hyperglycemia 0 1 0 5
Hematuria 0 1 0 1
Cough 0 1 0 0
Wheezing 0 1 0 0
Cardiac arrest 0 0 1 0
Perianal hemorrhage 0 0 1 0
Cyst infection 0 0 1 0
Incarcerated hernia 0 0 1 0
Hypoalbuminemia 0 0 1 1
Hypokalemia 0 0 2 3
Respiratory failure 0 0 1 1
Pruritus 0 0 1 0
Hypertension 0 0 1 0
Atrial fibrillation 0 0 0 1
Chest pain cardiac 0 0 0 1
Left ventricular systolic dysfunction 0 0 0 1
Supraventricular tachycardia 0 0 0 1
Dysphagia 0 0 0 1
Esophagitis 0 0 0 1
Lower gastrointestinal hemorrhage 0 0 0 1
Pain 0 0 0 1
Otitis media 0 0 0 1
Scrotal infection 0 0 0 1
Upper respiratory infection 0 0 0 1
Urinary tract infection 0 0 0 1
Wound infection 0 0 0 1
Fall 0 0 0 1
Fracture 0 0 0 1
Weight loss 0 0 0 1
Anorexia 0 0 0 1
Hyponatremia 0 0 0 3
Neck pain 0 0 0 1
Polyarthropathy 0 0 0 1
Syncope 0 0 0 2
Pleuritic pain 0 0 0 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Phase II
Hide Arm/Group Description

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 25 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 50 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

All-Cause Mortality
Cohort 1 Cohort 2 Cohort 3 Phase II
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1 Cohort 2 Cohort 3 Phase II
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   2/4 (50.00%)   6/6 (100.00%)   12/12 (100.00%) 
Blood and lymphatic system disorders         
Anemia  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Cardiac disorders         
Cardiac arrest  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Supraventricular tachycardia  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Ear and labyrinth disorders         
Otitis media  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Gastrointestinal disorders         
Constipation  1  0/8 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  0/12 (0.00%) 
Hemorrhoidal hemorrage  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Vomiting  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
General disorders         
Bleeding  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Edema  1  0/8 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  0/12 (0.00%) 
Fatigue  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Hernia  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Itching  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Progressive disease  1  2/8 (25.00%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Infections and infestations         
Bacteremia blood  1  2/8 (25.00%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Catheter related infection  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  1/12 (8.33%) 
Cyst infection  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Febrile neutropenia  1  3/8 (37.50%)  0/4 (0.00%)  1/6 (16.67%)  3/12 (25.00%) 
Lung infection  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  9/12 (75.00%) 
Scrotal infection  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Sepsis  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Injury, poisoning and procedural complications         
Fall  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Fracture  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Post operative hemorrhage (bone marrow biopsy site)  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Investigations         
Thrombocytopenia  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Metabolism and nutrition disorders         
Hyperglycemia  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Hypokalemia  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Nervous system disorders         
Confusion  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Intracranial hemorrhage  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Syncope  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Renal and urinary disorders         
Hematuria  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnea  1  0/8 (0.00%)  2/4 (50.00%)  0/6 (0.00%)  0/12 (0.00%) 
Respiratory failure  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Skin and subcutaneous tissue disorders         
Skin infection  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Skin ulceration  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Vascular disorders         
Hypotension  1  3/8 (37.50%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Thromboembolic event DVT  1  0/8 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 Cohort 2 Cohort 3 Phase II
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   4/4 (100.00%)   6/6 (100.00%)   12/12 (100.00%) 
Blood and lymphatic system disorders         
Anemia  1  2/8 (25.00%)  0/4 (0.00%)  2/6 (33.33%)  4/12 (33.33%) 
Cardiac disorders         
Acute systolic CHF/MV regurgitation  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Atrial flutter  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  4/12 (33.33%) 
Chest pain - cardiac  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Left ventricular systolic dysfunction  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Palpitations  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Pericardial effusion  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Sinus bradycardia  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Sinus tachycardia  1  1/8 (12.50%)  0/4 (0.00%)  1/6 (16.67%)  4/12 (33.33%) 
Supraventricular tachycardia  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Systolic murmur  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Ear and labyrinth disorders         
Ear pain  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Hearing impaired  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  2/12 (16.67%) 
Otitis mastoiditis  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Tinnitus  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  2/12 (16.67%) 
Vertigo  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Endocrine disorders         
Hypothyroidism  1  2/8 (25.00%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Eye disorders         
Blurred vision  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  3/12 (25.00%) 
Double vision  1  0/8 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  0/12 (0.00%) 
Dry eye  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Eye pain  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Flashing lights  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Visual disturbance/double vision  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Gastrointestinal disorders         
Abdominal pain  1  1/8 (12.50%)  0/4 (0.00%)  1/6 (16.67%)  5/12 (41.67%) 
Constipation  1  3/8 (37.50%)  1/4 (25.00%)  1/6 (16.67%)  7/12 (58.33%) 
Dental carries  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Diarrhea  1  4/8 (50.00%)  1/4 (25.00%)  4/6 (66.67%)  7/12 (58.33%) 
Dry mouth  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Dysphagia  1  2/8 (25.00%)  0/4 (0.00%)  1/6 (16.67%)  3/12 (25.00%) 
Esophagitis  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Gastric hemorrhage  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Hemorrhoidal hemorrhage  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Hemorrhoids  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Lower gastrointestinal hemorrhage  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Mucositis - oral  1  2/8 (25.00%)  1/4 (25.00%)  2/6 (33.33%)  8/12 (66.67%) 
Nausea  1  5/8 (62.50%)  3/4 (75.00%)  5/6 (83.33%)  8/12 (66.67%) 
Oral hemorrhage  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Rectal hemorrhage  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Rectal pain  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Vomiting  1  3/8 (37.50%)  2/4 (50.00%)  4/6 (66.67%)  7/12 (58.33%) 
General disorders         
Chills  1  3/8 (37.50%)  1/4 (25.00%)  2/6 (33.33%)  7/12 (58.33%) 
Edema face  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Edema limbs  1  6/8 (75.00%)  0/4 (0.00%)  3/6 (50.00%)  8/12 (66.67%) 
Fatigue  1  6/8 (75.00%)  4/4 (100.00%)  4/6 (66.67%)  9/12 (75.00%) 
Fever  1  3/8 (37.50%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Flu Like Symptoms  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Hypothermia  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Infusion related reaction  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Malaise  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  2/12 (16.67%) 
Non-cardiac chest pain  1  0/8 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  2/12 (16.67%) 
Pain  1  3/8 (37.50%)  1/4 (25.00%)  0/6 (0.00%)  2/12 (16.67%) 
Perianal hemorrhage  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Hepatobiliary disorders         
Splenomegaly  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Infections and infestations         
Bronchial infection  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Catheter related infection  1  0/8 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  0/12 (0.00%) 
Clostridium difficile  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Febrile neutropenia  1  1/8 (12.50%)  1/4 (25.00%)  2/6 (33.33%)  5/12 (41.67%) 
Gram positive cocci  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  2/12 (16.67%) 
Lip infection  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Lung infection  1  5/8 (62.50%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Oral thrush  1  1/8 (12.50%)  0/4 (0.00%)  1/6 (16.67%)  4/12 (33.33%) 
Scrotal infection  1  0/8 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  0/12 (0.00%) 
Sepsis  1  1/8 (12.50%)  0/4 (0.00%)  1/6 (16.67%)  1/12 (8.33%) 
Sinusitis  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  2/12 (16.67%) 
Skin infection  1  3/8 (37.50%)  3/4 (75.00%)  2/6 (33.33%)  0/12 (0.00%) 
Staphylococcus epidermis-blood  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Upper respiratory infection  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Urinary tract infection  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  2/12 (16.67%) 
VRE stool  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  2/12 (16.67%) 
Vulval infection  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Wound infection  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Injury, poisoning and procedural complications         
Bruising  1  2/8 (25.00%)  0/4 (0.00%)  0/6 (0.00%)  4/12 (33.33%) 
Eye abrasion  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Fall  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  2/12 (16.67%) 
Incarcerated hernia  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Perirectal abrasion  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Postoperative hemorrhage  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Vascular access complication  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Investigations         
Activated partial thromboplastin time prolonged  1  3/8 (37.50%)  0/4 (0.00%)  1/6 (16.67%)  3/12 (25.00%) 
Alanine aminotransferase increased  1  5/8 (62.50%)  3/4 (75.00%)  3/6 (50.00%)  9/12 (75.00%) 
Alkaline phosphatase increased  1  4/8 (50.00%)  1/4 (25.00%)  3/6 (50.00%)  4/12 (33.33%) 
Aspartate aminotransferase increased  1  4/8 (50.00%)  1/4 (25.00%)  1/6 (16.67%)  6/12 (50.00%) 
Blood bilirubin increased  1  4/8 (50.00%)  0/4 (0.00%)  4/6 (66.67%)  8/12 (66.67%) 
Cardiac troponin I increased  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Creatinine increased  1  4/8 (50.00%)  1/4 (25.00%)  1/6 (16.67%)  4/12 (33.33%) 
INR increased  1  2/8 (25.00%)  1/4 (25.00%)  1/6 (16.67%)  8/12 (66.67%) 
Lymphocyte count decreased  1  5/8 (62.50%)  1/4 (25.00%)  4/6 (66.67%)  9/12 (75.00%) 
Lymphocyte count increased  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Neutrophil count decreased  1  7/8 (87.50%)  0/4 (0.00%)  2/6 (33.33%)  2/12 (16.67%) 
Platelet count decreased  1  3/8 (37.50%)  2/4 (50.00%)  3/6 (50.00%)  7/12 (58.33%) 
Weight gain  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Weight loss  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  5/12 (41.67%) 
White blood cell decreased  1  7/8 (87.50%)  1/4 (25.00%)  5/6 (83.33%)  10/12 (83.33%) 
Metabolism and nutrition disorders         
Anorexia  1  2/8 (25.00%)  0/4 (0.00%)  1/6 (16.67%)  5/12 (41.67%) 
Dehydration  1  4/8 (50.00%)  0/4 (0.00%)  0/6 (0.00%)  4/12 (33.33%) 
Hypercalcemia  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Hyperglycemia  1  3/8 (37.50%)  1/4 (25.00%)  1/6 (16.67%)  4/12 (33.33%) 
Hyperkalemia  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  3/12 (25.00%) 
Hypermagnesemia  1  1/8 (12.50%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Hypernatremia  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  4/12 (33.33%) 
Hyperuricemia  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Hypoalbuminemia  1  6/8 (75.00%)  2/4 (50.00%)  2/6 (33.33%)  11/12 (91.67%) 
Hypocalcemia  1  6/8 (75.00%)  3/4 (75.00%)  5/6 (83.33%)  11/12 (91.67%) 
Hypoglycemia  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Hypokalemia  1  2/8 (25.00%)  1/4 (25.00%)  1/6 (16.67%)  7/12 (58.33%) 
Hypomagnesemia  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Hyponatremia  1  3/8 (37.50%)  2/4 (50.00%)  4/6 (66.67%)  7/12 (58.33%) 
Hypophosphatemia  1  5/8 (62.50%)  1/4 (25.00%)  3/6 (50.00%)  7/12 (58.33%) 
Musculoskeletal and connective tissue disorders         
Acute gout attack  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Back pain  1  1/8 (12.50%)  1/4 (25.00%)  0/6 (0.00%)  3/12 (25.00%) 
Bone pain  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  1/12 (8.33%) 
Generalized muscle weakness  1  5/8 (62.50%)  1/4 (25.00%)  3/6 (50.00%)  6/12 (50.00%) 
Lytic lesion in right parietal bone  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Muscle weakness lower limb  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Neck pain  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Pain in extremity  1  2/8 (25.00%)  2/4 (50.00%)  0/6 (0.00%)  1/12 (8.33%) 
Polyarthropathy  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Leukemia vasculitis left calf  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Nervous system disorders         
Delerium  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Dizziness  1  2/8 (25.00%)  3/4 (75.00%)  0/6 (0.00%)  3/12 (25.00%) 
Dysgeusia  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Facial muscle weakness  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Headache  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  4/12 (33.33%) 
Lethargy  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Paresthesia  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Presyncope  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Seizure  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  2/12 (16.67%) 
Somnolence  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Stroke  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  1/12 (8.33%) 
Tremor  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Psychiatric disorders         
Anxiety  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  1/12 (8.33%) 
Confusion  1  2/8 (25.00%)  0/4 (0.00%)  2/6 (33.33%)  2/12 (16.67%) 
Depression  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  2/12 (16.67%) 
Insomnia  1  1/8 (12.50%)  0/4 (0.00%)  1/6 (16.67%)  2/12 (16.67%) 
Renal and urinary disorders         
Acute kidney injury  1  1/8 (12.50%)  0/4 (0.00%)  2/6 (33.33%)  2/12 (16.67%) 
Cystitis noninfective  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Hematuria  1  1/8 (12.50%)  1/4 (25.00%)  1/6 (16.67%)  6/12 (50.00%) 
Proteinuria  1  1/8 (12.50%)  0/4 (0.00%)  1/6 (16.67%)  5/12 (41.67%) 
Renal tubular acidosis  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Urinary frequency  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  4/12 (33.33%) 
Urinary retention  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Reproductive system and breast disorders         
Scrotal pain  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders         
Atelectasis  1  3/8 (37.50%)  1/4 (25.00%)  0/6 (0.00%)  5/12 (41.67%) 
Cough  1  2/8 (25.00%)  2/4 (50.00%)  1/6 (16.67%)  6/12 (50.00%) 
Dyspnea  1  5/8 (62.50%)  1/4 (25.00%)  4/6 (66.67%)  8/12 (66.67%) 
Epistaxis  1  2/8 (25.00%)  0/4 (0.00%)  1/6 (16.67%)  3/12 (25.00%) 
Hoarseness  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Hypoxia  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  6/12 (50.00%) 
Nasal congestion  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Pleural effusion  1  2/8 (25.00%)  0/4 (0.00%)  0/6 (0.00%)  4/12 (33.33%) 
Pleural hemorrhage  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Pleuritic pain  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  2/12 (16.67%) 
Postnasal drip  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  2/12 (16.67%) 
Productive cough  1  2/8 (25.00%)  0/4 (0.00%)  3/6 (50.00%)  4/12 (33.33%) 
Pulmonary edema  1  2/8 (25.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Respiratory failure  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Sore throat  1  0/8 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  2/12 (16.67%) 
Wheezing  1  1/8 (12.50%)  1/4 (25.00%)  0/6 (0.00%)  1/12 (8.33%) 
Skin and subcutaneous tissue disorders         
Dry skin  1  1/8 (12.50%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Erythemia  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Pruritus  1  1/8 (12.50%)  1/4 (25.00%)  3/6 (50.00%)  4/12 (33.33%) 
Purpura  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  6/12 (50.00%) 
Rash maculo-papular  1  3/8 (37.50%)  1/4 (25.00%)  2/6 (33.33%)  7/12 (58.33%) 
Rash-petechial  1  1/8 (12.50%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Skin hyperpigmentation  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Skin ulceration  1  0/8 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  3/12 (25.00%) 
Vascular disorders         
Hematoma  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  1/12 (8.33%) 
Hot flashes  1  0/8 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Hypertension  1  1/8 (12.50%)  0/4 (0.00%)  1/6 (16.67%)  0/12 (0.00%) 
Hypotension  1  0/8 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  2/12 (16.67%) 
Thromboembolic event  1  0/8 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  1/12 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ravi Vij, M.D.
Organization: Washington University School of Medicine
Phone: 314-454-8304
EMail: rvij@dom.wustl.edu
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01016600     History of Changes
Other Study ID Numbers: 09-1816 / 201101749
First Submitted: November 17, 2009
First Posted: November 19, 2009
Results First Submitted: June 8, 2015
Results First Posted: September 7, 2015
Last Update Posted: September 7, 2015