Lenalidomide in Combination With Microtransplantation as Post-remission Therapy in AML
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|ClinicalTrials.gov Identifier: NCT02255162|
Recruitment Status : Terminated (Slow Accrual)
First Posted : October 2, 2014
Last Update Posted : August 18, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia (AML) Acute Myelocytic Leukemia Acute Myelogenous Leukemia Acute Granulocytic Leukemia Acute Non-Lymphocytic Leukemia||Drug: Lenalidomide Genetic: HLA-mismatched stem-cell Microtransplantation Drug: Cytarabine||Phase 1|
After the screening procedures confirm that the participant is eligible to participate in the research study. The participant will be given a study drug-dosing calendar.
The investigators are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants, not everyone who participates in this research study will receive the same dose of the study drug. The dose given will depend on the number of participants who have been enrolled in the study prior and how well they have tolerated their doses. Participants will receive the following:
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Feasibility of Lenalidomide in Combination With HLA-mismatched Stem-cell Microtransplantation as Post-remission Therapy in Patients With Acute Myeloid Leukemia (AML)|
|Actual Study Start Date :||January 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
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:
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.
Other Name: •Revlimid®
Genetic: HLA-mismatched stem-cell Microtransplantation
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.
- Maximum Tolerated Dose (MTD) of lenalidomide after microtransplantation [ Time Frame: Baseline, 42 Days ]
- Disease Free Survival [ Time Frame: 1 year ]
- Overall Survival [ Time Frame: 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 [ Time Frame: 2 Years ]
- To identify incidence and severity of acute and chronic graft versus host disease (GVHD). [ Time Frame: 2 Years ]
- To detect and categorize, according to severity, the cumulative incidences of toxicities [ Time Frame: 2 Years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255162
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Amir Fathi, MD||Massachusetts General Hospital|