Lenalidomide for Myelodysplastic Syndrome Refractory to Hypomethylating Agents
|ClinicalTrials.gov Identifier: NCT01246076|
Recruitment Status : Completed
First Posted : November 23, 2010
Results First Posted : January 5, 2016
Last Update Posted : January 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndromes||Drug: Lenalidomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of High Dose Lenalidomide in Patients With Myelodysplastic Syndrome Refractory to Hypomethylating Agents|
|Study Start Date :||June 2011|
|Primary Completion Date :||May 2014|
|Study Completion Date :||August 2015|
Lenalidomide 50 mg/day for two 28 day cycles.
Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles.
Other Name: Revlimid
- Number of Participants With Confirmed Responses (Complete Remission, Partial Remission, or Hematologic Improvement) as Defined by the International Working Group Criteria [ Time Frame: Up to 56 weeks (14 cycles of treatment) ]
- Complete remission (CR): ≤5% myeloblasts bone marrow blasts, normal maturation in all cell lines (dysplasia will be noted), ≥11 g/dl peripheral blood hemoglobin, ≥100x10^9cells/μL peripheral blood platelets, ≥1000 cells/ μL peripheral blood absolute neutrophil count (ANC), and 0% peripheral blood blasts.
- Marrow complete remission (MCR): ≤5% myeloblasts and decreased by ≥50% compared to pre-treatment bone marrow blasts, bone marrow morphology not relevant, and peripheral blood (if hematological improvement they will be noted in addition to marrow CR).
- Partial remission (PR): previously had ≥5% myeloblasts and now have ≥5% myeloblasts but decreased by ≥50% compared to pre-treatment, bone marrow morphology not relevant, ≥11 g/dl peripheral blood hemoglobin, ≥100x109cells/μL peripheral blood platelets, ≥1000 cells/ μL peripheral blood ANC, and 0% peripheral blood blasts
- Overall Survival Rate [ Time Frame: 6 months after end of treatment (up to 82 weeks from start of treatment) ]-Overall survival rate is the percentage of participants who were alive 6 months after end of treatment.
- Duration of Response [ Time Frame: Until 6 months after end of treatment ]
- Time to Discontinuation of Treatment [ Time Frame: Up to 56 weeks (14 cycles) ]
- Toxicity as Measured by Number of Participants Who Experienced Related Grade 3-5 Adverse Events Based on CTCAE Version 4 [ Time Frame: 30 days after end of treatment (up to 60 weeks) ]
- Time to Progression [ Time Frame: Up to 6 months after completion of treatment (up to 82 weeks from start of treatment) ]The time to progression is defined as the time from registration to the date of progression or last follow-up. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246076
|United States, Arizona|
|Mayo Clinic Scottsdale AZ|
|Scottsdale, Arizona, United States|
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Ravi Vij, M.D.||Washington University School of Medicine|