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Maintenance Therapy in Acute Myeloid Leukemia (AML) Patients

This study has been completed.
Celgene Corporation
Information provided by (Responsible Party):
University Health Network, Toronto Identifier:
First received: August 11, 2009
Last updated: June 17, 2015
Last verified: August 2009
The purpose of this study is to determine if Revlimid will help maintain patients with acute myeloid leukemia in remission.

Condition Intervention Phase
Acute Myeloid Leukemia Drug: Revlimid Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University Health Network, Toronto:

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 [ 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 Measures:
  • 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. ]

Enrollment: 24
Study Start Date: June 2008
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Lenalidomide
No Intervention: B
Arm B will not receive Revlimid but an observational arm

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00957385

Canada, Ontario
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Celgene Corporation
Principal Investigator: Andre Schuh, MD.FRCP(C) University Health Network Princess Margaret Hospital
  More Information

Responsible Party: University Health Network, Toronto Identifier: NCT00957385     History of Changes
Other Study ID Numbers: RV-AML-PI-166
Study First Received: August 11, 2009
Last Updated: June 17, 2015

Keywords provided by University Health Network, Toronto:

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents processed this record on August 18, 2017