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5-Azacytidine With Lenalidomide in Patients With High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)

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ClinicalTrials.gov Identifier: NCT01038635
Recruitment Status : Completed
First Posted : December 24, 2009
Results First Posted : February 10, 2017
Last Update Posted : February 10, 2017
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Drug: 5-Azacytidine
Drug: Lenalidomide
Enrollment 94
Recruitment Details Recruitment Period: December 23, 2009 to June 21, 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.
Pre-assignment Details Of the 94 participants registered, six were ineligible therefore not assigned to groups nor treated.
Arm/Group Title 5-AZA + LEN 10 mg 5-AZA + LEN 15 mg 5-AZA + LEN 20 mg 5-AZA + LEN 25 mg 5-AZA + LEN 50 mg 5-AZA + LEN 75 mg for 5 Days 5-AZA + LEN 75 mg for 10 Days Phase II: AZA + LEN 50 mg Phase II: AZA+ LEN 25 mg
Hide Arm/Group Description Phase I: 5-Azacytidine (5-AZA) + Lenalidomide (LEN): 5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10. 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days. 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days. 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days. 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days. 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days. 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days. 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days. 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
Period Title: Overall Study
Started 5 3 3 3 4 3 7 20 40
Completed 3 3 3 3 3 3 5 15 38
Not Completed 2 0 0 0 1 0 2 5 2
Reason Not Completed
Disease Progression             2             0             0             0             0             0             1             4             0
Death             0             0             0             0             1             0             1             1             2
Arm/Group Title 5-AZA + LEN 10 mg 5-AZA + LEN 15 mg 5-AZA + LEN 20 mg 5-AZA + LEN 25 mg 5-AZA + 50 LEN 5-AZA + LEN 75 mg 5 Days 5-AZA + LEN 75 mg for 10 Days Phase II: 5-AZA + LEN 50 mg Phase II: AZA+ LEN 25 mg Total
Hide Arm/Group Description 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days. 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days. 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days. 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days. 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days. 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days. 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days. Total of all reporting groups
Overall Number of Baseline Participants 5 3 3 3 4 3 7 20 40 88
Hide Baseline Analysis Population Description
Baseline characteristics represented in study phase, Phase I and Phase II separately.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants 3 participants 3 participants 3 participants 4 participants 3 participants 7 participants 20 participants 40 participants 88 participants
65
(55 to 79)
54
(54 to 66)
66
(65 to 69)
66
(54 to 71)
71
(65 to 79)
64
(63 to 77)
63
(32 to 70)
72
(36 to 88)
66
(38 to 85)
67
(32 to 88)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 3 participants 3 participants 4 participants 3 participants 7 participants 20 participants 40 participants 88 participants
Female
1
  20.0%
1
  33.3%
3
 100.0%
2
  66.7%
2
  50.0%
2
  66.7%
4
  57.1%
9
  45.0%
16
  40.0%
40
  45.5%
Male
4
  80.0%
2
  66.7%
0
   0.0%
1
  33.3%
2
  50.0%
1
  33.3%
3
  42.9%
11
  55.0%
24
  60.0%
48
  54.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 3 participants 3 participants 4 participants 3 participants 7 participants 20 participants 40 participants 88 participants
Hispanic or Latino
1
  20.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
2
  10.0%
0
   0.0%
4
   4.5%
Not Hispanic or Latino
4
  80.0%
3
 100.0%
3
 100.0%
2
  66.7%
4
 100.0%
3
 100.0%
6
  85.7%
18
  90.0%
37
  92.5%
80
  90.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
3
   7.5%
4
   4.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 3 participants 3 participants 4 participants 3 participants 7 participants 20 participants 40 participants 88 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
1
  14.3%
2
  10.0%
1
   2.5%
6
   6.8%
White
5
 100.0%
2
  66.7%
3
 100.0%
3
 100.0%
4
 100.0%
2
  66.7%
5
  71.4%
18
  90.0%
36
  90.0%
78
  88.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
3
   7.5%
4
   4.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 3 participants 3 participants 3 participants 4 participants 3 participants 7 participants 20 participants 40 participants 88 participants
5 3 3 3 4 3 7 20 40 88
1.Primary Outcome
Title Number of Dose Limiting Toxicities for Determining Maximum Tolerated Dose (MTD) of Lenalidomide in Combination With 5-azacytidine (5-AZA)
Hide Description DLT determined only during first course of therapy, at least 28 days from treatment of last participant before a new dose level initiated. All severe (Grade 3-4) non-hematological toxicities that are drug related considered for DLT determination. If 1 participant develops grade III-IV non-hematological toxicity, 3 more will be accrued at that particular dose level. If 2 or more participants develop grade III-IV non-hematologic toxicity, the doses of the combination at which this occurs will be considered too toxic. A total of 10 patients will be treated at the maximally tolerated dose (MTD) of the combination (the dose level below that considered to be too toxic) to confirm its tolerability.
Time Frame 3-8 week cycles, up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 5-AZA + 5 Days LEN 10 mg 5-AZA + 5 Days LEN 15 mg 5-AZA + 5 Days LEN 20 mg 5-AZA + 5 Days LEN 25 mg 5-AZA + 5 Days LEN 50 mg 5-AZA + 5 Days LEN 75 mg 5-AZA + 10 Days LEN 75 mg 75 mg
Hide Arm/Group Description:
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days.
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
Overall Number of Participants Analyzed 5 3 3 3 4 3 7
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5-AZA + 5 Days LEN 10 mg, 5-AZA + 5 Days LEN 15 mg, 5-AZA + 5 Days LEN 20 mg, 5-AZA + 5 Days LEN 25 mg, 5-AZA + 5 Days LEN 50 mg, 5-AZA + 5 Days LEN 75 mg, 5-AZA + 10 Days LEN 75 mg 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Maximal tolerated dose
Estimated Value 75
Estimation Comments Maximal tolerated dose not reached as no dose limiting toxicity documented. MTD considered to be last dose level.
2.Secondary Outcome
Title Overall Response Rate (ORR) of Lenalidomide in Combination With 5-azacytidine (5-AZA) in Participants With Leukemia
Hide Description Response defined as complete remission (CR) or complete remission with incomplete platelet recovery (CRi) for AML or any response for myelodysplastic syndrome (MDS) using international working group (IWG)-06 criteria. Complete response (CR) requires normalization of peripheral counts (absolute neutrophil count 10^9/L or more, platelet count 100 x 10^9/L or more), and a bone marrow with 5% or less marrow blasts. A hematologic improvement (HI) is defined as a CR with a platelet count above 30 x 10^9/L, without the need for transfusion of Platelets.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I: 5-AZA + LEN MTD Phase II: 5-AZA + LEN
Hide Arm/Group Description:
5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10.
All subjects received 75mg/m²/day AZA days 1-5 of each 28-day cycle. LEN 50 mg was administered orally for 10 days, with dose later amended to LEN 25 mg daily for 5 days.
Overall Number of Participants Analyzed 28 60
Measure Type: Number
Unit of Measure: percentage of participants
14 45
3.Secondary Outcome
Title Overall Response: Number of Participants With CR or CRi Response
Hide Description Response defined as complete remission (CR) or complete remission with incomplete platelet recovery (CRi) for AML or any response for myelodysplastic syndrome (MDS) using international working group (IWG)-06 criteria. Complete response (CR) requires normalization of peripheral counts (absolute neutrophil count 10^9/L or more, platelet count 100 x 10^9/L or more), and a bone marrow with 5% or less marrow blasts. A hematologic improvement (HI) is defined as a CR with a platelet count above 30 x 10^9/L, without the need for transfusion of Platelets.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study: 5-AZA + LEN MTD
Hide Arm/Group Description:
Combined reporting for all phases, Phase I (5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10) and Phase II All subjects received 75mg/m²/day AZA days 1-5 of each 28-day cycle. LEN 50 mg administered orally for 10 days, with dose later amended to LEN 25 mg daily for 5 days.
Overall Number of Participants Analyzed 88
Measure Type: Number
Unit of Measure: participants
Complete Remission (CR) 15
Incomplete Count Recover (CRi) 16
Time Frame Adverse events collected for 28 day cycle, up to 8 weeks following first course.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 5-AZA + LEN 10 mg 5-AZA + LEN 15 mg 5-AZA + LEN 20 mg 5-AZA + LEN 25 mg 5-AZA + LEN 50 mg 5-AZA + 5 Days LEN 75 mg 5-AZA + 10 Days LEN 75 mg Phase II: AZA + LEN 50 mg Phase II: AZA+ LEN 25 mg
Hide Arm/Group Description Phase I: 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days. Phase I: 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days. 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days. 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days. 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days. 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days. 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days. 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days. 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
All-Cause Mortality
5-AZA + LEN 10 mg 5-AZA + LEN 15 mg 5-AZA + LEN 20 mg 5-AZA + LEN 25 mg 5-AZA + LEN 50 mg 5-AZA + 5 Days LEN 75 mg 5-AZA + 10 Days LEN 75 mg Phase II: AZA + LEN 50 mg Phase II: AZA+ LEN 25 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
5-AZA + LEN 10 mg 5-AZA + LEN 15 mg 5-AZA + LEN 20 mg 5-AZA + LEN 25 mg 5-AZA + LEN 50 mg 5-AZA + 5 Days LEN 75 mg 5-AZA + 10 Days LEN 75 mg Phase II: AZA + LEN 50 mg Phase II: AZA+ LEN 25 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/5 (80.00%)      3/3 (100.00%)      3/3 (100.00%)      1/3 (33.33%)      1/4 (25.00%)      3/3 (100.00%)      7/7 (100.00%)      11/20 (55.00%)      21/40 (52.50%)    
Blood and lymphatic system disorders                   
Leukocytosis  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/20 (0.00%)  0 0/40 (0.00%)  0
Neutropenic Fever  1  0/5 (0.00%)  0 2/3 (66.67%)  3 3/3 (100.00%)  4 0/3 (0.00%)  0 1/4 (25.00%)  2 1/3 (33.33%)  2 0/7 (0.00%)  0 4/20 (20.00%)  6 6/40 (15.00%)  10
Cardiac disorders                   
Atrial Fibrillation  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Cardio-pulmonary arrest  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Sinus Tachycardia  1  0/5 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Supraventricular Atrial Flutter  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Gastrointestinal disorders                   
Diarrhea  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Hemorrhage Gastrointestinal  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 2/20 (10.00%)  2 0/40 (0.00%)  0
nausea  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Partial small bowel obstruction  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/20 (0.00%)  0 0/40 (0.00%)  0
General disorders                   
Death  1  1/5 (20.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 3/7 (42.86%)  3 2/20 (10.00%)  2 5/40 (12.50%)  5
Pain  1  1/5 (20.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 1/7 (14.29%)  2 1/20 (5.00%)  1 2/40 (5.00%)  2
Prolongation of hospitalization  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Infections and infestations                   
Infection other  1  1/5 (20.00%)  1 3/3 (100.00%)  3 1/3 (33.33%)  1 1/3 (33.33%)  2 0/4 (0.00%)  0 1/3 (33.33%)  2 4/7 (57.14%)  7 2/20 (10.00%)  2 3/40 (7.50%)  3
Injury, poisoning and procedural complications                   
Fall  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Right Femur Fracture (fall)  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Investigations                   
Fever  1  1/5 (20.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 2/20 (10.00%)  3 0/40 (0.00%)  0
Metabolism and nutrition disorders                   
Dyhydration  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/20 (0.00%)  0 0/40 (0.00%)  0
Hyperglycemia  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  2
Tumor Lysis Syndrome  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Nervous system disorders                   
Altered Mental Status  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 3/20 (15.00%)  3 0/40 (0.00%)  0
Dizziness  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Hemorrhage Central Nervous System (CNS)  1  1/5 (20.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Intracranial Hemorrhage  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Seizures  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Syncope  1  1/5 (20.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Renal and urinary disorders                   
Acute Renal Failure  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Hematuria  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Urinary Tract Infection  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 2/7 (28.57%)  3 1/20 (5.00%)  1 0/40 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                   
Branchospasm  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Dyspnea  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Left Pleural Effusion  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Pneumonia  1  2/5 (40.00%)  2 1/3 (33.33%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 1/7 (14.29%)  1 7/20 (35.00%)  8 3/40 (7.50%)  6
Respiratory Distress  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 2/20 (10.00%)  2 0/40 (0.00%)  0
Respiratory Failure  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  2 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Shortness of Breath  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders                   
Cellulitis  1  1/5 (20.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 4/20 (20.00%)  5 0/40 (0.00%)  0
Rash  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 2/20 (10.00%)  3 0/40 (0.00%)  0
Right Jaw Swelling  1  0/5 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Vascular disorders                   
Bruising  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Hypotension  1  0/5 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 2/20 (10.00%)  2 1/40 (2.50%)  1
Subdural Hematoma  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Thrombus  1  0/5 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/20 (0.00%)  0 0/40 (0.00%)  0
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%
5-AZA + LEN 10 mg 5-AZA + LEN 15 mg 5-AZA + LEN 20 mg 5-AZA + LEN 25 mg 5-AZA + LEN 50 mg 5-AZA + 5 Days LEN 75 mg 5-AZA + 10 Days LEN 75 mg Phase II: AZA + LEN 50 mg Phase II: AZA+ LEN 25 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/5 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      4/4 (100.00%)      3/3 (100.00%)      7/7 (100.00%)      20/20 (100.00%)      40/40 (100.00%)    
Blood and lymphatic system disorders                   
Neutropenic Fever  1  0/5 (0.00%)  0 2/3 (66.67%)  2 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 2/3 (66.67%)  2 1/7 (14.29%)  1 8/20 (40.00%)  8 11/40 (27.50%)  11
Cardiac disorders                   
Atrial fibrillation  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Chest pain unclear etiology  1  1/5 (20.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Coronary artery disease (caused chest pain)  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Heart Palpitations  1  0/5 (0.00%)  0 0/0  0 0/0  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/20 (0.00%)  0 1/40 (2.50%)  1
possible chemotherapy-related cardiomyopathy  1  1/5 (20.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Tachycardia  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Gastrointestinal disorders                   
Abdominal pain  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 1/40 (2.50%)  1
C. difficile colitis  1  0/5 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Constipation  1  1/5 (20.00%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 2/3 (66.67%)  2 1/4 (25.00%)  1 1/3 (33.33%)  1 2/7 (28.57%)  2 4/20 (20.00%)  4 16/40 (40.00%)  16
Diarrhea  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 6/40 (15.00%)  6
Diverticulitis  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Gastrointestinal Bleed  1  0/0  0 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Gum Hemorrhage  1  0/0  0 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Gum infection (left jaw cellulitis and gingivitis)  1  0/0  0 0/0  0 0/0  0 0/0  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/0  0 0/0  0 0/40 (0.00%)  0
Vomiting  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 1/40 (2.50%)  1
Nausea  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 3/20 (15.00%)  3 7/40 (17.50%)  7
Tooth Abcess/Infection  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/20 (0.00%)  0 1/40 (2.50%)  1
General disorders                   
Fatigue  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/3 (66.67%)  2 2/4 (50.00%)  2 1/3 (33.33%)  1 3/7 (42.86%)  3 0/20 (0.00%)  0 0/40 (0.00%)  0
Fever  1  0/5 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 2/20 (10.00%)  2 16/40 (40.00%)  16
Fluid retention  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Multi organ failure  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/20 (0.00%)  0 0/40 (0.00%)  0
Weakness  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Infections and infestations                   
Aspergillus fungal pneumonia  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/7 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Infection, E-coli bacteremia  1  0/5 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Enterococcus bacteremia  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/3 (66.67%)  2 0/7 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Infection, Fungal pneumonia  1  0/5 (0.00%)  0 2/3 (66.67%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/0  0 0/7 (0.00%)  0 3/20 (15.00%)  3 1/40 (2.50%)  1
influenzae, Haemophilus and stenotrophomonas  1  1/5 (20.00%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/0  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Infection  1  0/5 (0.00%)  0 0/0  0 0/0  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Pneumonia  1  3/5 (60.00%)  3 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 2/7 (28.57%)  2 2/20 (10.00%)  2 10/40 (25.00%)  10
Sepsis  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/3 (66.67%)  2 1/7 (14.29%)  1 1/20 (5.00%)  1 1/40 (2.50%)  1
Urinarty Tract Infection (UTI)  1  0/5 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/4 (25.00%)  1 1/3 (33.33%)  1 1/7 (14.29%)  1 0/20 (0.00%)  0 0/40 (0.00%)  0
Vancomycin-resistant enterococci infection (VRE)  1  0/5 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/7 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Injury, poisoning and procedural complications                   
Fall  1  1/5 (20.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Infection of intravenous line  1  1/5 (20.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Investigations                   
Creatine Elevation  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Elevated bilirubin  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/3 (66.67%)  2 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Non-neutropenic fever  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/3 (66.67%)  2 0/7 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Metabolism and nutrition disorders                   
Loss of appetite  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 2/40 (5.00%)  2
Hyperglycemia  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Musculoskeletal and connective tissue disorders                   
Bone pain  1  1/5 (20.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 1/7 (14.29%)  1 0/20 (0.00%)  0 2/40 (5.00%)  2
Muscle aches  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Severe muscle spasms of the lower back  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/20 (0.00%)  0 0/40 (0.00%)  0
Tendinitis  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Pain, Right Flank  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/20 (0.00%)  0 0/40 (0.00%)  0
Nervous system disorders                   
Alteration in mental status  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/20 (0.00%)  0 1/40 (2.50%)  1
Change of smell  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Dizziness  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 3/40 (7.50%)  3
Hand tremors  1  0/5 (0.00%)  0 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0 0/7 (0.00%)  0 1/20 (5.00%)  1 1/40 (2.50%)  1
Headache  1  0/5 (0.00%)  0 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Intracranial hemorrhage/bleed  1  1/5 (20.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Jitteriness  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Night sweats  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Subdural Hemorrhage  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Syncopal Episode  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Unsteady gait  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/20 (0.00%)  0 0/40 (0.00%)  0
Psychiatric disorders                   
Cognitive changes  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Confusion  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Insomnia  1  1/5 (20.00%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/4 (0.00%)  0 1/3 (33.33%)  1 1/7 (14.29%)  1 0/20 (0.00%)  0 2/40 (5.00%)  2
Renal and urinary disorders                   
Hematuria  1  0/5 (0.00%)  0 0/0  0 0/0  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Renal failures  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/20 (0.00%)  0 0/40 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                   
Bilateral parotitis  1  1/5 (20.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Chronic obstructive pulmonary disease (COPD)  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Diffuse alveolar hemorrhage  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Respiratory distress  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Respiratory failure  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 1/40 (2.50%)  1
Respiratory syncytial virus  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/0  0 0/40 (0.00%)  0
Sinus infection  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Shortness of breath  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 2/40 (5.00%)  2
Skin and subcutaneous tissue disorders                   
Cellulitis  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 2/7 (28.57%)  2 0/20 (0.00%)  0 1/40 (2.50%)  1
Flushing  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Fungal infection/Skin nodules  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/7 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Itching  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/20 (5.00%)  1 7/40 (17.50%)  7
Cellulitis  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/3 (66.67%)  2 0/7 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Macropapular rash on trunk  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
nonpruritic skin rash  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  2 0/7 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Pruritus/Itching  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 2/20 (10.00%)  2 3/40 (7.50%)  3
Rash  1  1/5 (20.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/4 (50.00%)  2 0/3 (0.00%)  0 1/7 (14.29%)  1 0/20 (0.00%)  0 10/40 (25.00%)  10
Scalp Pruritis  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 2/40 (5.00%)  2
Vascular disorders                   
Hypotension  1  0/5 (0.00%)  0 0/0  0 0/0  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/7 (0.00%)  0 1/20 (5.00%)  1 1/40 (2.50%)  1
Thrombocytopenia  1  0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/20 (0.00%)  0 2/40 (5.00%)  2
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
Name/Title: Guillermo Garcia-Manero, MD/Professor, Leukemia
Organization: The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7734
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01038635     History of Changes
Other Study ID Numbers: 2009-0467
NCI-2011-01941 ( Registry Identifier: NCI CTRP )
First Submitted: December 23, 2009
First Posted: December 24, 2009
Results First Submitted: December 19, 2016
Results First Posted: February 10, 2017
Last Update Posted: February 10, 2017