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Trial record 3 of 16 for:    LENALIDOMIDE AND Leukemia AND Azacitidine

Azacitidine and Lenalidomide for Relapsed and Refractory Patients With Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT01743859
Recruitment Status : Completed
First Posted : December 6, 2012
Results First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Myeloid Leukemia
Interventions Drug: Azacitidine
Drug: Lenalidomide
Other: Off Therapy
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Azacitidine + Lenalidomide + Off Therapy
Hide Arm/Group Description Patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone. Afterwards beginning on Day 8 patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28. They will then enter a 2 week observation period where they will be monitored and assessed.
Period Title: Overall Study
Started 37
Completed 28
Not Completed 9
Arm/Group Title Azacitidine + Lenalidomide + Off Therapy
Hide Arm/Group Description

Patients will receive 7 days of azacitidine followed by 3 weeks of lenalidomide. They will then have 2 weeks off therapy, for a maximum of 12 cycles.

Azacitidine: Enrolled patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone.

Lenalidomide: Beginning on day 8, patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28.

Off Therapy: 2 weeks off therapy, then begin sequence again for 12 weeks.

Overall Number of Baseline Participants 37
Hide Baseline Analysis Population Description
Relapsed and refractory AML patients who received azacitidine and lenalidomide
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
<=18 years
1
   2.7%
Between 18 and 65 years
6
  16.2%
>=65 years
30
  81.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants
73  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Female
13
  35.1%
Male
24
  64.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants
37
1.Primary Outcome
Title Percentage of Participants With Complete Remission or Complete Remission With Incomplete Recovery Blood Counts
Hide Description Change in baseline to end of study. To be assessed by standard criteria based on bone marrow examination. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time Frame Interim assessment after 18 patients (estimated 2 years) and full assessment after 37 patients (estimated 3-4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Relapsed/refractory AML patients who received azacitidine and lenalidomide
Arm/Group Title Azacitidine + Lenalidomide + Off Therapy
Hide Arm/Group Description:
Patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone. Afterwards beginning on Day 8 patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28. They will then enter a 2 week observation period where they will be monitored and assessed.
Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: percentage of participants
11
2.Primary Outcome
Title Overall Response Rate
Hide Description Change in baseline to end of study. To be assessed by standard criteria based on bone marrow examination
Time Frame Planned assessment after enrollment of all 37 patients (estimated 3-4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
relapsed/refractory patients who received azacitidine and lenaldiomide
Arm/Group Title Azacitidine + Lenalidomide + Off Therapy
Hide Arm/Group Description:
Patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone. Afterwards beginning on Day 8 patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28. They will then enter a 2 week observation period where they will be monitored and assessed.
Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: percentage of participants
52
3.Secondary Outcome
Title Response or Remission Duration
Hide Description Change in baseline to end of study. To be assessed by standard criteria based on bone marrow examination
Time Frame Depending on outcomes, will initiate this assessment after 2 years and will continue until completion of study, estimated at 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Relapsed and refractory AML patients who received azacitidine and lenalidomide
Arm/Group Title Azacitidine + Lenalidomide + Off Therapy
Hide Arm/Group Description:
Patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone. Afterwards beginning on Day 8 patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28. They will then enter a 2 week observation period where they will be monitored and assessed.
Overall Number of Participants Analyzed 37
Median (95% Confidence Interval)
Unit of Measure: days
125
(23 to 308)
4.Secondary Outcome
Title Toxicity and SAEs Related to Treatment
Hide Description Change in baseline to end of study. To be measured based on Common Terminology Criteria for Adverse Events (CTCAE) criteria
Time Frame Will begin assessment with first patient and will continue until completion of study, estimated to be 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Relapsed and refractory AML patients who received azacitidine and lenalidomide -See toxicity data reported for results
Arm/Group Title Azacitidine + Lenalidomide + Off Therapy
Hide Arm/Group Description:
Patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone. Afterwards beginning on Day 8 patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28. They will then enter a 2 week observation period where they will be monitored and assessed.
Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: percentage of SAEs related to treatment
46
5.Secondary Outcome
Title Overall Survival
Hide Description Change in baseline to end of study
Time Frame Depending on outcomes, will begin assessment at 2 years and will continue until completion of study, estimated to be at four years
Hide Outcome Measure Data
Hide Analysis Population Description
Relapsed and refractory AML patients who received azacitidine and lenalidomide
Arm/Group Title Azacitidine + Lenalidomide + Off Therapy
Hide Arm/Group Description:
Patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone. Afterwards beginning on Day 8 patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28. They will then enter a 2 week observation period where they will be monitored and assessed.
Overall Number of Participants Analyzed 37
Median (95% Confidence Interval)
Unit of Measure: days
166
(35 to 355)
6.Secondary Outcome
Title Progression-free Survival
Hide Description Change in baseline to end of study. To be assessed by standard criteria based on bone marrow examination
Time Frame Depending on outcomes, will initiate this assessment after 2 years and will continue until completion of study, estimated at 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Relapsed and refractory AML patients who received azacitidine and lenalidomide
Arm/Group Title Azacitidine + Lenalidomide + Off Therapy
Hide Arm/Group Description:
Patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone. Afterwards beginning on Day 8 patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28. They will then enter a 2 week observation period where they will be monitored and assessed.
Overall Number of Participants Analyzed 37
Median (95% Confidence Interval)
Unit of Measure: days
112
(33 to 355)
7.Secondary Outcome
Title Determine Biomarkers That Predict Response/Toxicity
Hide Description Change in baseline to end of study. Planned assessments of methylation changes and other biomarkers. Computational biology modeling used to identify biomarkers and predict response.
Time Frame Three years after initiating study
Hide Outcome Measure Data
Hide Analysis Population Description
Relapsed and refractory AML patients who received azacitidine and lenalidomide.
Arm/Group Title Azacitidine + Lenalidomide + Off Therapy
Hide Arm/Group Description:
Patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone. Afterwards beginning on Day 8 patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28. They will then enter a 2 week observation period where they will be monitored and assessed.
Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: patients w/response predictor mutations
9
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Azacitidine + Lenalidomide + Off Therapy
Hide Arm/Group Description Patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone. Afterwards beginning on Day 8 patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28. They will then enter a 2 week observation period where they will be monitored and assessed.
All-Cause Mortality
Azacitidine + Lenalidomide + Off Therapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Azacitidine + Lenalidomide + Off Therapy
Affected / at Risk (%)
Total   24/37 (64.86%) 
Blood and lymphatic system disorders   
Febrile Neutropenia   11/37 (29.73%) 
Cardiac disorders   
Syncope   2/37 (5.41%) 
Hypertension   2/37 (5.41%) 
Gastrointestinal disorders   
Clostridium Defficile   2/37 (5.41%) 
Infections and infestations   
Sepsis   2/37 (5.41%) 
Pneuomonia   2/37 (5.41%) 
Respiratory, thoracic and mediastinal disorders   
Pneumothorax   1/37 (2.70%) 
Hypoxia   2/37 (5.41%) 
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 0%
Azacitidine + Lenalidomide + Off Therapy
Affected / at Risk (%)
Total   28/37 (75.68%) 
Blood and lymphatic system disorders   
Neutropenia   21/37 (56.76%) 
Thrombocytopenia   12/37 (32.43%) 
Anemia   15/37 (40.54%) 
Gastrointestinal disorders   
Nausea   16/37 (43.24%) 
Constipation   17/37 (45.95%) 
Diarrhea   21/37 (56.76%) 
General disorders   
Fatigue   28/37 (75.68%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea   17/37 (45.95%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Daniel Pollyea
Organization: University of Colorado
EMail: daniel.pollyea@ucdenver.edu
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01743859     History of Changes
Other Study ID Numbers: 12-1283.cc
NCI-2012-03191 ( Other Identifier: National Cancer Institute )
First Submitted: November 16, 2012
First Posted: December 6, 2012
Results First Submitted: July 5, 2019
Results First Posted: October 8, 2019
Last Update Posted: October 8, 2019