Myelodysplastic Syndromes Clinical Trial
Official title:
A Phase I Clinical Trial to Evaluate the Maximally Tolerated Dose (MTD), Dose Limiting Toxicities (DLTs) and Safety Profiles of Increasing Doses of Lenalidomide After Allo-HCT in AML and MDS Subjects With Minimal Residual Disease (MRD) Detected by the CD34+ Mixed Chimerism Analysis (UF-BMT-MRD-101)
The purpose of this study is to determine the maximum tolerated dose, dose limiting side effects, and the safety of increasing doses of lenalidomide in patients with AML and MDS who have a small amount of detectable disease after allogeneic stem cell transplant.
All subjects entering the screening phase will receive a unique subject number. This number
will be used to identify the subject throughout the study. Additional test to include:
physical examinations, blood tests, and if applicable pregnancy test will be performed as
part of participation in this research study.
Lenalidomide will be administered for a total of 42 days. The starting dose will be 2.5 mg
given orally every other day on days 1-21 of a 28-day cycle for 2 cycles. Dose escalations
and de-escalations will be made until the maximum tolerated dose is reached.
The dose levels of lenalidomide will be as follows:
Dose Level 1: 2.5 mg
Dose Level 2: 2.5 mg
Dose Level 3: 5 mg
Dose Level 4: 7.5 mg
Doses should be taken at approximately the same time each day.
Subjects must be instructed to swallow lenalidomide capsules whole with water at the same
time each day. Do not break, chew or open the capsules.
Each subject will keep an accurate record of lenalidomide dosing on the Subject Dosing Diary.
This diary will be kept in the research record as source documentation of lenalidomide
dosing. Study personnel will review the dosing instructions with each subject at each study
visit. Subjects will be asked to bring any unused drug and empty drug containers to the study
site at the next visit for reconciliation with the Subject Dosing Diary.
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