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A Dose Range Finding Study of Lenalidomide in Non-5q Chromosome Deletion in Low and Intermediate Risk Myelodysplastic Syndrome (MDS) Patients

2014-07-23 21:22:14 | BioPortfolio

Summary

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.

Description

STUDY DESIGN:

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.

STUDY ENDPOINTS:

Primary:

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

Secondary:

1.Safety (type, frequency, severity, and relationship of adverse events to study treatment) with dose escalation.

Study Design

Allocation: Non-Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Myelodysplastic Syndrome (MDS) Low to Intermediate-1

Intervention

Lenalidomide

Location

Thomas Jefferson University
Philadelphia
Pennsylvania
United States
19107

Status

Recruiting

Source

Thomas Jefferson University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:22:14-0400

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