Skip to main content
OpenTrials
Completed

NCT Number: NCT00957385

Maintenance Therapy in Acute Myeloid Leukemia (AML) Patients

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Revlimid

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Celgene Corporation

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Aug 12, 2009
Registry last updated
Jun 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.