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Sponsored by: |
Tel-Aviv Sourasky Medical Center |
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Information provided by: | Tel-Aviv Sourasky Medical Center |
ClinicalTrials.gov Identifier: | NCT00704704 |
Study Objectives The aim of the study is to evaluate the safety and efficacy of the combination of 5-Aza-Cytidine + Thalidomide on the course of hrMDS patients.
Primary end point:
• To evaluate the overall response rate (CR+PR) of the combination of 5-Aza-Cytidine + Thalidomide in hrMDS patients (INT-2 and High risk as defined by IPSS).
Secondary end points:
Study design:
This is a multicenter, phase II, single arm study designed to evaluate the safety and efficacy of the combination of Thalidomide+5-Aza-Cytidine in high risk MDS patients (INT-2 and High risk defined by IPSS) who are older than 18 years of age. Potential study subjects will sign an informed consent prior to undergoing any study related procedure. Number of patients to be enrolled 50.
Treatment plan: 5-aza-cytidine (75 mg m2/d) will be injected subcutaneously in 5-day cycle every 28 days, for a total of 12 cycles.
Thalidomide will be given at the dose of 50 mg/d, from day 1 until for 6 months together with 5-aza-cytidine .
Treatment period includes 5-aza-cytidine (75 mg m2/d) will be injected subcutaneously in 5-day cycle every 28 days. Total number of 12 cycles or until progression or toxicity. Cycle delay of maximum 2 weeks in case of hematological toxicity grade 3-4 at investigator discretion.
Duration of the follow up period is 6 months. Duration of study The duration of the treatment period is approximately 12 months. This time is required to complete the treatment, and to determine the safety profile and the response rate. The duration of the Follow period will be approximately a half year. The occurrence of PD will determine the duration of progression-free survival of each patient.
Condition | Intervention | Phase |
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Myelodysplastic Syndrome |
Drug: 5-aza-cytidine and Thalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Single Arm Study to Determine the Safety and Efficacy of Azacitidine, and Thalidomide in Higher Risk Myelodysplastic Syndrome |
Estimated Enrollment: | 50 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient has the following laboratory values within 14 days before Baseline (day 1 of the Cycle 1):
Exclusion Criteria:
-
Contact: Moshe Mittelman, MD | 972-3-6973366 | moshemt@TASMC.HEALTH.GOV.IL |
Contact: Elizabeth Naparstek, MD | 972-524266435 | enaparstek@tasmc.health.gov.il |
Israel | |
Hematolpgical department Tel Aviv Medical Center | |
Tel-Aviv, Israel |
Study ID Numbers: | TASMC-08-MM-TLV-0069-08-CTIL |
Study First Received: | June 23, 2008 |
Last Updated: | June 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00704704 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
high risk MDS IPSS 5-AZA-Cytidine Thalidomide |
response rate cytogenetic response QOL questionaries INT-2 or High risk MDS |
Myelodysplastic syndromes Preleukemia Thalidomide Precancerous Conditions Hematologic Diseases |
Myelodysplasia Myelodysplastic Syndromes Azacitidine Bone Marrow Diseases |
Antimetabolites Anti-Infective Agents Disease Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Anti-Bacterial Agents Neoplasms Pathologic Processes Syndrome Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Leprostatic Agents |