Maintenance Therapy in Acute Myeloid Leukemia (AML) Patients

June 17, 2015 updated by: University Health Network, Toronto

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network, Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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

Outcome Measure
Time Frame
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.
The 1st interim analysis will be done after all subjects have receieved 12 cycles and the 2nd when all subjects have completed treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Celgene Corporation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

August 11, 2009

First Submitted That Met QC Criteria

August 11, 2009

First Posted (Estimate)

August 12, 2009

Study Record Updates

Last Update Posted (Estimate)

June 19, 2015

Last Update Submitted That Met QC Criteria

June 17, 2015

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RV-AML-PI-166

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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