Acute Myelogenous Leukemia Clinical Trial
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)
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.
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:
- Cytarabine
- Microtransplantation
- Lenalidomide
;
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