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Determine the optimal dose of Lenalidomide (Revlimid) in MDS patients, IPSS Score LOW or INT-1 who do not have the 5q- cytogenetic abnormality by dose escalation within the MTD.
The overall study will follow a Phase I/II design. Details of the phase I portion of the study are as follows: subjects will be entered according to the standard 3+3 design. If there are no DLTs among the first 3 patients enrolled to a dose level, enrollment will continue at the next higher dose level. If one patient among the first 3 patients enrolled to a dose level experiences a DLT, 3 more patients will be treated at that dose level up to a total of 6 subjects. If only 1 out of 6 patients treated at a dose level experience a DLT, enrollment with continue at the next higher dose level. If 2 or more patients within a dose level experience a DLT, then the maximum tolerated dose (MTD) will have been exceeded and the preceding dose level will be evaluated as the MTD. At least 6 patients must be evaluated at the MTD; therefore if only 3 patients had been enrolled at the preceding dose level, an additional 3 patients would be enrolled at that dose level. This evaluation of dose levels will continue until the MTD has been defined or until dose level 3 has been evaluated. The MTD is defined as the highest dose level at which 0 or 1 out of 6 patients experience a DLT. Dose levels to be tested will be 15mg, 20mg, and 25mg. Each dose level will be given daily on days 1-21, followed by 7 days rest (one cycle). Cycles will repeat every 28 days.
Dose Level Lenalidomide Schedule
1. 15mg/day for d1-21 out of 28 days
2. 20mg/day for d1-21 out of 28 days
3. 25mg/day for d1-21 out of 28 days
The 6 patients at the found MTD will continue into the phase II portion of the study. See section 10.3.3.2 for details on design of the phase II portion.
Meanwhile, a neutropenia mobilization test will be performed at the first occurrence of a 50% decrease in ANC from baseline. A bone marrow biopsy will be performed followed by a single dose of Prednisone at 1 mg/kg administered 24-48 after BM, then followed by a CBC 24 hours post prednisone dose. The mobilization test will be done once for each patient, if applicable.
1. Determine CR, PR, and rate of stable disease in MDS patients, IPSS Score LOW or INT-1 who do not have the 5q- cytogenetic abnormality according to the IWG criteria for response in >10mg doses of lenalidomide
2. MTD of lenalidomide
1.Safety (type, frequency, severity, and relationship of adverse events to study treatment) with dose escalation.
Allocation: Non-Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Myelodysplastic Syndrome (MDS) Low to Intermediate-1
Thomas Jefferson University
Thomas Jefferson University
Published on BioPortfolio: 2014-07-23T21:22:14-0400
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