Maintenance Therapy in Acute Myeloid Leukemia (AML) Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00957385
First received: August 11, 2009
Last updated: June 29, 2010
Last verified: August 2009
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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. ] [ Designated as safety issue: Yes ]

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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: June 2008
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2011 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00957385

Contacts
Contact: Andre Schuh, MD FRCP(C) 416 946 2399 andre.schuh@uhn.on.ca

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

No publications provided

Responsible Party: Dr Andre Schuh, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00957385     History of Changes
Other Study ID Numbers: RV-AML-PI-166
Study First Received: August 11, 2009
Last Updated: June 29, 2010
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Leukemia
Remission

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Lenalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014