Maintenance Therapy in Acute Myeloid Leukemia (AML) Patients

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT00957385
Collaborator
Celgene Corporation (Industry)
24
1
2
82
0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if Revlimid will help maintain patients with acute myeloid leukemia in remission.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Apr 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: A

Arm A will receive Revlimid.

Drug: Revlimid
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.
Other Names:
  • Lenalidomide
  • No Intervention: B

    Arm B will not receive Revlimid but an observational arm

    Outcome Measures

    Primary Outcome Measures

    1. To assess the feasibility and assess the effect on relapse free survival by giving Revlimid in the post complete remission maintenance setting [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 Measures

    1. To determine the toxicity of Revlimid when given in the maintenance setting. [The 1st interim analysis will be done after all subjects have receieved 12 cycles and the 2nd when all subjects have completed treatment.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Health Network, Princess Margaret Hospital Toronto Ontario Canada M5G 2M9

    Sponsors and Collaborators

    • University Health Network, Toronto
    • Celgene Corporation

    Investigators

    • Principal Investigator: Andre Schuh, MD.FRCP(C), University Health Network Princess Margaret Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT00957385
    Other Study ID Numbers:
    • RV-AML-PI-166
    First Posted:
    Aug 12, 2009
    Last Update Posted:
    Jun 19, 2015
    Last Verified:
    Aug 1, 2009
    Keywords provided by University Health Network, Toronto
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 19, 2015