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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Genzyme |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00412243 |
Purpose
Primary Objectives (Phase I):
Primary Objectives (Phase II):
| Condition | Intervention | Phase |
|---|---|---|
|
Burkitt's Lymphoma Lymphoblastic Lymphoma Acute Lymphoblastic Leukemia |
Drug: Clofarabine Drug: Cyclophosphamide |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase I/II Study of Clofarabine Plus Cyclophosphamide for Relapsed and Refractory Acute Lymphoblastic Leukemia (ALL) |
| Estimated Enrollment: | 55 |
| Study Start Date: | March 2006 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Clofarabine + Cyclophosphamide: Experimental |
Drug: Clofarabine
40 mg/m^2 Daily for 3 Days
Drug: Cyclophosphamide
Beginning dose 200 mg/m^2 every 12 hours for 3 days
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Stefan Faderl, MD | 713-745-4613 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Stefan Faderl, MD | |
| Principal Investigator: | Stefan Faderl, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | UT MD Anderson Cancer Center ( Stefan Faderl, MD / Associate Professor ) |
| Study ID Numbers: | 2005-0552 |
| Study First Received: | December 14, 2006 |
| Last Updated: | September 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00412243 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Burkitt's Lymphoma Lymphoblastic Lymphoma Acute Lymphoblastic Leukemia Clofarabine Clofarex |
Clolar Cyclophosphamide Neosar Cytoxan |
|
Leukemia, Lymphoid Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Tumor Virus Infections Cyclophosphamide Neoplasms, Experimental Lymphoma, B-Cell Leukemia Therapeutic Uses Epstein-Barr Virus Infections Alkylating Agents Lymphoma Clofarabine |
Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Immune System Diseases Immunosuppressive Agents Pharmacologic Actions Herpesviridae Infections Virus Diseases Lymphatic Diseases Neoplasms Burkitt Lymphoma Myeloablative Agonists DNA Virus Infections Antineoplastic Agents, Alkylating Antirheumatic Agents |