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Trial record 40 of 52 for:    LENALIDOMIDE AND Leukemia AND Acute Myeloid Leukemia

Trial of High Dose Lenalidomide in Patients With MDS and AML With Trilineage Dysplasia

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ClinicalTrials.gov Identifier: NCT00867308
Recruitment Status : Terminated (Lack of efficacy)
First Posted : March 23, 2009
Results First Posted : October 17, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Myelodysplastic Syndrome
Interventions Drug: Lenalidomide 50 mg
Drug: Lenalidomide 15 mg
Enrollment 32
Recruitment Details  
Pre-assignment Details 2 participants on the 15mg arm and 3 participants on the 50mg arm were screen failures.
Arm/Group Title Lenalidomide 15 mg Lenalidomide 50 mg
Hide Arm/Group Description

Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 15 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.

Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.

Patients without evidence of response after 4 cycles will be taken off-study.

Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 50 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.

Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.

Patients without evidence of response after 4 cycles will be taken off-study.

Period Title: Overall Study
Started 9 18
Completed 0 0
Not Completed 9 18
Reason Not Completed
Death             1             0
Adverse Event             1             4
Lack of Efficacy             6             12
Withdrawal by Subject             1             2
Arm/Group Title Lenalidomide 15 mg Lenalidomide 50 mg Total
Hide Arm/Group Description

Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 15 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.

Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.

Patients without evidence of response after 4 cycles will be taken off-study.

Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 50 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.

Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.

Patients without evidence of response after 4 cycles will be taken off-study.

Total of all reporting groups
Overall Number of Baseline Participants 9 18 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 18 participants 27 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  33.3%
4
  22.2%
7
  25.9%
>=65 years
6
  66.7%
14
  77.8%
20
  74.1%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants 18 participants 27 participants
77
(47 to 88)
70
(53 to 79)
72
(47 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 18 participants 27 participants
Female
1
  11.1%
4
  22.2%
5
  18.5%
Male
8
  88.9%
14
  77.8%
22
  81.5%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Response Rate
Hide Description Number of participants with a complete or partial response according to International Working Group 2006 criteria.
Time Frame 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide 15 mg Lenalidomide 50 mg
Hide Arm/Group Description:

Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 15 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.

Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.

Patients without evidence of response after 4 cycles will be taken off-study.

Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 50 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.

Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.

Patients without evidence of response after 4 cycles will be taken off-study.

Overall Number of Participants Analyzed 9 18
Measure Type: Count of Participants
Unit of Measure: Participants
Complete response
0
   0.0%
0
   0.0%
Partial response
0
   0.0%
2
  11.1%
2.Secondary Outcome
Title Grade 3-4 Toxicity
Hide Description Number of participants who experienced at least one grade 3-4 non-hematological toxicity by CTCAE 3.0 that was attributed to lenalidomide.
Time Frame Up to 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide 15 mg Lenalidomide 50 mg
Hide Arm/Group Description:

Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 15 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.

Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.

Patients without evidence of response after 4 cycles will be taken off-study.

Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 50 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.

Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.

Patients without evidence of response after 4 cycles will be taken off-study.

Overall Number of Participants Analyzed 9 18
Measure Type: Count of Participants
Unit of Measure: Participants
6
  66.7%
12
  66.7%
Time Frame Up to 8 months
Adverse Event Reporting Description Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for >3 weeks from last dose of lenalidomide with a bone marrow cellularity of <5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
 
Arm/Group Title Lenalidomide 15 mg Lenalidomide 50 mg
Hide Arm/Group Description

Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 15 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.

Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.

Patients without evidence of response after 4 cycles will be taken off-study.

Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 50 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.

Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.

Patients without evidence of response after 4 cycles will be taken off-study.

All-Cause Mortality
Lenalidomide 15 mg Lenalidomide 50 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   3/9 (33.33%)      2/18 (11.11%)    
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide 15 mg Lenalidomide 50 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/9 (33.33%)      9/18 (50.00%)    
Cardiac disorders     
Hypotension  1  0/9 (0.00%)  0 1/18 (5.56%)  1
General disorders     
Epistaxis  1  1/9 (11.11%)  1 0/18 (0.00%)  0
Infections and infestations     
Clostridium difficile infection  1  0/9 (0.00%)  0 1/18 (5.56%)  1
Endocarditis  1  1/9 (11.11%)  1 0/18 (0.00%)  0
Febrile neutropenia  1  1/9 (11.11%)  1 1/18 (5.56%)  1
Fungal pneumonia  1  0/9 (0.00%)  0 1/18 (5.56%)  1
Meningitis  1  1/9 (11.11%)  1 0/18 (0.00%)  0
Pericarditis  1  0/9 (0.00%)  0 1/18 (5.56%)  1
Pneumonia  1  0/9 (0.00%)  0 3/18 (16.67%)  3
Nervous system disorders     
Weakness - leg  1  1/9 (11.11%)  1 0/18 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  0/9 (0.00%)  0 1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders     
Hypoxia  1  1/9 (11.11%)  1 1/18 (5.56%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lenalidomide 15 mg Lenalidomide 50 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/9 (77.78%)      13/18 (72.22%)    
Blood and lymphatic system disorders     
Bleeding  1  3/9 (33.33%)  3 3/18 (16.67%)  5
Bruising  1  0/9 (0.00%)  0 3/18 (16.67%)  3
Epistaxis  1  4/9 (44.44%)  5 3/18 (16.67%)  3
Cardiac disorders     
Atrial fibrillation  1  0/9 (0.00%)  0 2/18 (11.11%)  2
Edema  1  1/9 (11.11%)  1 7/18 (38.89%)  10
Lightheadedness  1  0/9 (0.00%)  0 2/18 (11.11%)  2
Gastrointestinal disorders     
Constipation  1  1/9 (11.11%)  1 6/18 (33.33%)  8
Diarrhea  1  1/9 (11.11%)  1 4/18 (22.22%)  7
Nausea  1  1/9 (11.11%)  1 1/18 (5.56%)  1
Stomatitis  1  1/9 (11.11%)  1 3/18 (16.67%)  3
Vomiting  1  0/9 (0.00%)  0 3/18 (16.67%)  3
Xerostomia  1  0/9 (0.00%)  0 2/18 (11.11%)  2
General disorders     
Anorexia  1  1/9 (11.11%)  1 4/18 (22.22%)  4
Cough  1  3/9 (33.33%)  3 4/18 (22.22%)  4
Fatigue  1  5/9 (55.56%)  5 8/18 (44.44%)  12
Headache  1  1/9 (11.11%)  2 1/18 (5.56%)  1
Hoarseness  1  0/9 (0.00%)  0 2/18 (11.11%)  2
Myalgia  1  0/9 (0.00%)  0 6/18 (33.33%)  11
Pain - back  1  0/9 (0.00%)  0 2/18 (11.11%)  2
Pain - chest  1  1/9 (11.11%)  1 1/18 (5.56%)  1
Pain - tooth  1  0/9 (0.00%)  0 2/18 (11.11%)  2
Infections and infestations     
Febrile neutropenia  1  3/9 (33.33%)  3 1/18 (5.56%)  1
Fever  1  1/9 (11.11%)  2 2/18 (11.11%)  2
Thrush  1  1/9 (11.11%)  1 1/18 (5.56%)  2
Investigations     
Anemia  1  2/9 (22.22%)  2 0/18 (0.00%)  0
Hyperbilirubinemia  1  2/9 (22.22%)  2 1/18 (5.56%)  1
Hypokalemia  1  1/9 (11.11%)  1 1/18 (5.56%)  1
Hyponatremia  1  1/9 (11.11%)  1 0/18 (0.00%)  0
Leukopenia  1  2/9 (22.22%)  2 0/18 (0.00%)  0
Thrombocytopenia  1  3/9 (33.33%)  3 0/18 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/9 (0.00%)  0 2/18 (11.11%)  2
Nervous system disorders     
Confusion  1  1/9 (11.11%)  1 1/18 (5.56%)  1
Hallucination  1  0/9 (0.00%)  0 2/18 (11.11%)  2
Neuropathy  1  0/9 (0.00%)  0 2/18 (11.11%)  2
Weakness  1  0/9 (0.00%)  0 6/18 (33.33%)  6
Renal and urinary disorders     
Hematuria  1  0/9 (0.00%)  0 2/18 (11.11%)  2
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  1/9 (11.11%)  1 3/18 (16.67%)  3
Skin and subcutaneous tissue disorders     
Pruritis  1  1/9 (11.11%)  2 8/18 (44.44%)  13
Rash  1  3/9 (33.33%)  5 6/18 (33.33%)  9
Xerosis  1  0/9 (0.00%)  0 2/18 (11.11%)  2
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
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: Amy DeZern, MD
Organization: Johns Hopkins University
Phone: 4105027208
EMail: adezern1@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00867308     History of Changes
Other Study ID Numbers: J0882
RV- MDS-PI-295 ( Other Identifier: Celgene Corporation )
NA_00019818 ( Other Identifier: JHMIRB )
First Submitted: March 19, 2009
First Posted: March 23, 2009
Results First Submitted: September 21, 2018
Results First Posted: October 17, 2018
Last Update Posted: October 17, 2018