Revlimid in Transfusion Dependent Patients
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|ClinicalTrials.gov Identifier: NCT01178814|
Recruitment Status : Unknown
Verified January 2016 by Mark Heaney, Columbia University.
Recruitment status was: Active, not recruiting
First Posted : August 10, 2010
Last Update Posted : January 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndrome||Drug: Revlimid (Lenalidomide)||Phase 2|
The first Revlimid® study reported by List et al included all transfusion dependent MDS patients, but given the early experience which showed a better response in del(5q) patients and those with lower risk disease, more patients belonging to this category were entered on the trial. The subsequent multi-center studies were focused entirely on the low/Int-1 patients who were transfusion dependent. In the present study, we would like to recapitulate the initial study by only treating the transfusion dependent, low and intermediate-1 risk MDS patients without deletion (5q). Since the predictive assay is most applicable for the non-del(5q) patients, and to avoid confusion resulting from an admixture of patients with del(5q) for whom the drug is already FDA approved, we have elected to restrict this clinical trial to only the non-del(5q) patients.
In the present study, only the non-del(5q) transfusion dependent, low and intermediate-1 risk MDS patients will be treated with single agent Revlimid®. All patients will have their pre-therapy bone marrows studied by gene expression microarray, Luminex bead assay, and real-time PCR.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Trial of Revlimid® in Transfusion Dependent Patients With Non-del (5q) Low/Intermediate-1 Risk Myelodysplastic Syndrome|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||September 2016|
Revlimid (Lenalidomide) capsule taken orally once a day
Drug: Revlimid (Lenalidomide)
The starting dose will be 10 mg days 1-28 with the first dose reduction going to 5 mg days 1-28 of a 28 day cycle. Therapy will cease if there is no response after 12 weeks.
Other Name: Revlimid
- Change in response signature in transfusion dependent MDS patients [ Time Frame: Up to 12 weeks from baseline ]The trial will be testing the Revlimid® (lenalidomide) response signature in patients who have transfusion dependent, non-del(5q), low and intermediate-1 risk myelodysplastic syndromes (MDS) in order to confirm the predictive value of the signature and to establish the boundaries of the z-score which can be used to pre-select patients in future clinical studies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01178814
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Mark Heaney, MD||Columbia University|