NCT00957385

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2009

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

June 19, 2015

Status Verified

August 1, 2009

Enrollment Period

6.8 years

First QC Date

August 11, 2009

Last Update Submit

June 17, 2015

Conditions

Acute Myeloid Leukemia

Keywords

LeukemiaRemission

Outcome Measures

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

    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.

    The 1st interim analysis will be done after all subjects have receieved 12 cycles and the 2nd when all subjects have completed treatment.

Study Arms (2)

A

ACTIVE COMPARATOR

Arm A will receive Revlimid.

Drug: Revlimid

B

NO INTERVENTION

Arm B will not receive Revlimid but an observational arm

Interventions

RevlimidDRUG

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.

Also known as: Lenalidomide
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Acute myeloid leukemia in remission.
  • Able to take aspirin 81mgs daily.

You may not qualify if:

  • Pregnant or breast feeding females.
  • Known hypersensitivity to thalidomide.
  • Any prior use of lenalidomide.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteLeukemia

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Andre Schuh, MD.FRCP(C)

    University Health Network Princess Margaret Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2009

First Posted

August 12, 2009

Study Start

June 1, 2008

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

June 19, 2015

Record last verified: 2009-08

Locations

CA(1)