Back to resultsMaintenance Therapy in Acute Myeloid Leukemia (AML) Patients
Primary Purpose
Acute Myeloid Leukemia
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Revlimid
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Leukemia, Remission
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Acute myeloid leukemia in remission.
- Able to take aspirin 81mgs daily.
Exclusion Criteria:
- Pregnant or breast feeding females.
- Known hypersensitivity to thalidomide.
- Any prior use of lenalidomide.
Sites / Locations
- University Health Network, Princess Margaret Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
A
B
Arm Description
Arm A will receive Revlimid.
Arm B will not receive Revlimid but an observational arm
Outcomes
Primary Outcome Measures
To assess the feasibility and assess the effect on relapse free survival by giving Revlimid in the post complete remission maintenance setting
Secondary Outcome Measures
To determine the toxicity of Revlimid when given in the maintenance setting.
Full Information
NCT ID
NCT00957385
First Posted
August 11, 2009
Last Updated
June 17, 2015
Sponsor
University Health Network, Toronto
Collaborators
Celgene Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00957385
Brief Title
Maintenance Therapy in Acute Myeloid Leukemia (AML) Patients
Official Title
A Randomized Phase II Study of Lenalidomide Maintenance Therapy in AML Patients Aged > 60 Years in CR1 or Higher and < 60 Years in CR2 or Higher
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Celgene Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if Revlimid will help maintain patients with acute myeloid leukemia in remission.
Detailed Description
At present, the majority of AML patients >60 years of age that achieve CR and thereafter successfully complete further chemotherapy, are not candidates for allogeneic bone marrow transplantation (alloBMT) due to their age. Rather, this group of patients is simply observed until relapse occurs. In this age group, the median duration of CR is only ~10 months. The survival of patients <60 years of age who are not candidates for transplantation (due to donor unavailability), and who are in CR2 or higher is also extremely poor. Several lines of evidence suggest that the immune system - and in particular AML specific CTLs and NK cells - is capable of recognizing and clearing AML cells.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Leukemia, Remission
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Arm A will receive Revlimid.
Arm Title
B
Arm Type
No Intervention
Arm Description
Arm B will not receive Revlimid but an observational arm
Intervention Type
Drug
Intervention Name(s)
Revlimid
Other Intervention Name(s)
Lenalidomide
Intervention Description
10mgs PO daily for 21 days of each 28 day cycle. Number of cycles: total of 24 or until subject relapses or unacceptable toxicity develops.
Primary Outcome Measure Information:
Title
To assess the feasibility and assess the effect on relapse free survival by giving Revlimid in the post complete remission maintenance setting
Time Frame
The 1st interim analysis will be done once all subjects have completed 12 cycles, and the 2nd interim analysis will be done once all subjects have completed treatment.
Secondary Outcome Measure Information:
Title
To determine the toxicity of Revlimid when given in the maintenance setting.
Time Frame
The 1st interim analysis will be done after all subjects have receieved 12 cycles and the 2nd when all subjects have completed treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Acute myeloid leukemia in remission.
Able to take aspirin 81mgs daily.
Exclusion Criteria:
Pregnant or breast feeding females.
Known hypersensitivity to thalidomide.
Any prior use of lenalidomide.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre Schuh, MD.FRCP(C)
Organizational Affiliation
University Health Network Princess Margaret Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network, Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Maintenance Therapy in Acute Myeloid Leukemia (AML) Patients
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