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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the feasibility and assess the effect on relapse free survival by giving Revlimid in the post complete remission maintenance setting

Outcome 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.

Safety Issue:

Yes

Principal Investigator

Andre Schuh, MD.FRCP(C)

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network Princess Margaret Hospital

Authority:

Canada: Health Canada

Study ID:

RV-AML-PI-166

NCT ID:

NCT00957385

Start Date:

June 2008

Completion Date:

February 2012

Related Keywords:

  • Acute Myeloid Leukemia
  • Leukemia
  • Remission
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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