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Safety and Feasibility of Lenalidomide in Combination With HLA-mismatched Stem-cell Microtransplantation as Post-remission Therapy in Patients With Acute Myeloid Leukemia (AML)
Sponsor study identifier
interventional
8
1 country
1
Study Start
January 2015
Actual (reported)Primary Completion
December 2016
Actual (reported)Study Completion
December 2016
Actual (reported)This research study is evaluating the safety and tolerability of the drug lenalidomide in combination with and following mismatched related donor microtransplantation in high risk AML patients in first remission. This study also aims to define the maximum tolerated dose (MTD) of lenalidomide given in this setting. Microtransplantation seeks to give the participant donor cells in hopes that those cells can attack the underlying cancer. However, since the donor cells do not replace all of the host cells, it can hopefully avoid many of the serious risks involved with standard transplant, including graft-vs.-host disease (GVHD) - a complication where the donor cells attack the participant's normal body. Recent studies have suggested that lenalidomide can help aid donor cells to attack cancer when given after a stem cell transplant. This trial is trying to see if lenalidomide can help encourage the attack of leukemia cells by donor cells given as part of microtransplantation. The FDA (the U.S. Food and Drug Administration) has approved lenalidomide but it has been approved for other uses such as in the treatment of other cancers including multiple myeloma and non-Hodgkin lymphoma. Although lenalidomide has been studied in patients with AML, it has not been approved by the FDA for standard use in AML. Lenalidomide is a compound made by the Celgene Corporation. It has properties which could demonstrate antitumor effects. The exact antitumor mechanism of action of lenalidomide is unknown.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 26, 2014
Actual (reported)October 2, 2014
Actual (reported)January 2015
Actual (reported)December 2016
Actual (reported)December 2016
Actual (reported)Maximum Tolerated Dose (MTD) of lenalidomide after microtransplantation
Baseline, 42 Days
Disease Free Survival
1 year
Overall Survival
1 Year
To assess immunomodulatory effects of this combination through measurement of T cell subsets by flow cytometric techniques and through microchimerism analysis at multiple points on study
Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. Participants will receive the following: * Cytarabine-intravenous, fixed dosage, given 5 times during cycle * HLA-mismatched stem-cell microtransplantation * Lenalidomide-administered daily per cycle
Patients will receive lenalidomide starting on day 6 of each post-remission cycle, following conclusion of cytarabine post-remission therapy on days 1-5. Following count recovery in the third post-remission cycle, patients will then receive lenalidomide daily as a maintenance therapy.
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Amir Fathi, MD
Massachusetts General Hospital
8 participants (actual enrollment reported by the registry).
First Submitted
September 26, 2014
First Posted
October 2, 2014
Study Start
January 2015
Actual (reported)2 Years
To identify incidence and severity of acute and chronic graft versus host disease (GVHD).
2 Years
To detect and categorize, according to severity, the cumulative incidences of toxicities
2 Years
Patient will receive HLA-mismatched stem cell microtransplant infusion on day 6 of each post-remission cycle, following conclusion of course of cytarabine in each cycle.
Patients will receive cytarabine post-remission therapy for 3 cycles, on days 1-5 of each cycle.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 2016
Actual (reported)Study Completion
December 2016
Actual (reported)Last Updated
August 18, 2017
Record last verified: 2017-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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