Maintenance Therapy in Acute Myeloid Leukemia (AML) Patients

University Health Network, Toronto

Status and phase: Completed; Phase 2

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Revlimid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00957385

RV-AML-PI-166

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

A

Active Comparator group

Description:

Arm A will receive Revlimid.

Treatment:

Drug: Revlimid

B

No Intervention group

Description:

Arm B will not receive Revlimid but an observational arm