Maintenance Therapy in Acute Myeloid Leukemia (AML) Patients

NCT ID: NCT00957385

Last Updated: 2015-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2015-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Arm A will receive Revlimid.

Group Type ACTIVE_COMPARATOR

Revlimid

Intervention Type 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.

B

Arm B will not receive Revlimid but an observational arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Revlimid

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.

Intervention Type DRUG

Other Intervention Names

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Lenalidomide

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene Corporation

INDUSTRY

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andre Schuh, MD.FRCP(C)

Role: PRINCIPAL_INVESTIGATOR

University Health Network Princess Margaret Hospital

Locations

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University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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RV-AML-PI-166

Identifier Type: -

Identifier Source: org_study_id

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