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Sponsors and Collaborators: |
Thomas Jefferson University Celgene Corporation |
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Information provided by: | Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT00699842 |
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.
Condition | Intervention | Phase |
---|---|---|
Myelodysplastic Syndrome (MDS) Low to Intermediate-1 |
Drug: Lenalidomide |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Optimal Dose Study of Lenalidomide in the Non-5q- LOW and INT-1 Risk MDS Patients |
Estimated Enrollment: | 25 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Dose Level Lenalidomide Schedule
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
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:
Secondary:
1.Safety (type, frequency, severity, and relationship of adverse events to study treatment) with dose escalation.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory test results within these ranges:
Disease free of prior malignancies for 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast
Exclusion Criteria:
History of thromboembolic disease within the past 6 months, regardless of anticoagulation
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Contact: Joshua J Schoppe, B.A., CCRP | 215-955-0030 | joshua.schoppe@jefferson.edu |
United States, Pennsylvania | |
Thomas Jefferson University | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Contact: Amanda Peterson 215-955-8042 amanda.peterson@jefferson.edu | |
Contact: Maureen O'Connell, RN 215-955-9244 maureen.oconnell@jefferson.edu | |
Thomas Jefferson University | Recruiting |
Philadephia, Pennsylvania, United States, 19107 | |
Contact: Amanda Peterson 215-955-8042 amanda.peterson@jefferson.edu | |
Contact: Maureen O'Connell, RN 215-955-9244 maureen.oconnell@jefferson.edu | |
Principal Investigator: Emmaunel Besa, MD |
Responsible Party: | Thomas Jeffeson University ( Emmaunel Besa, MD. ) |
Study ID Numbers: | RV-MDS-PI-244, IND #101536 |
Study First Received: | June 13, 2008 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00699842 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms Chromosome Deletion Preleukemia Precancerous Conditions |
Hematologic Diseases Myelodysplastic Syndromes Lenalidomide Bone Marrow Diseases |
Disease Precancerous Conditions Hematologic Diseases Antineoplastic Agents Myelodysplastic Syndromes Lenalidomide Pharmacologic Actions |
Preleukemia Neoplasms Pathologic Processes Syndrome Therapeutic Uses Bone Marrow Diseases |