Maintenance Therapy in Acute Myeloid Leukemia (AML) Patients

Phase 2

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Revlimid

• Registration Number: NCT00957385
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study Start: 2008-06
• Status Verified: 2009-08
• Study First Submitted: 2009-08-11
• Study First Submitted QC: 2009-08-11
• Study First Posted: 2009-08-12
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-06-17
• Last Update Posted: 2015-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Diagnosis of Acute myeloid leukemia in remission.
• Able to take aspirin 81mgs daily.

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Exclusion Criteria

• Pregnant or breast feeding females.
• Known hypersensitivity to thalidomide.
• Any prior use of lenalidomide.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Revlimid	Arm A will receive Revlimid.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University Health Network, Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada