Maintenance Therapy in Acute Myeloid Leukemia (AML) Patients

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00957385

Enrollment

Registered

2009-08-12

Start date

2008-06-30

Completion date

2015-04-30

Last updated

2015-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

Leukemia, Remission

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.

Interventions

DRUGRevlimid

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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	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

Measure	Time frame
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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026