Phase I Trial of Maintenance Lenalidomide in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome Post Allogeneic Bone Marrow Transplantation
The purpose of this study is determine whether lenalidomide can directly inhibit leukemic
stem cells in vivo and can be used to prevent the relapse of leukemia stem cells after
transplant. A concern with any post transplant intervention is the possibility of multiple
drug interactions, potential for graft versus host disease exacerbation and/or induction of
cytopenia. Therefore, the smallest doses of lenalidomide (5 mg) that has been used in this
setting will be utilized as dose level 1. Starting six months post-transplant, patients will
begin on a daily dose of lenalidomide. Dependent on the cohort, patients will receive 5 to
20 mg of lenalidomide post transplant. The maximum tolerated dose (MTD) will be determined
by the incidence of grade III-IV toxicities of all organs and grade II-IV GVHD. Duration of
treatment is six months.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated dose as assessed by NCI CTCAE, Version 4.0 and Graft versus Host Disease Staging
All patients will be followed closely and evaluated for toxicity. For grade III-IV non hematological toxicity or grade IV hematological toxicity associated with lenalidomide will be held until the toxicity resolves and then will be started at a lower dose; Patients who develop grade II to IV GVHD on study will stop lenalidomide
4 week cycle; the expected time frame is 24 weeks (or 6 cycles)
Yes
Mehrdad Abedi, MD
Principal Investigator
University of California, Davis
United States: Food and Drug Administration
UCDCC#227
NCT01433965
August 2012
October 2015
Name | Location |
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University of California Davis | Sacramento, California 95817 |