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Sponsors and Collaborators: |
Columbia University Genzyme |
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Information provided by: | Columbia University |
ClinicalTrials.gov Identifier: | NCT00529360 |
Hypothesis: Myeloablative conditioning using a dose escalation of clofarabine in combination with cytarabine (ARA-C) and total body irradiation (TBI) will lead to improved survival for previously untransplanted children and adolescents with acute lymphoblastic leukemia (ALL) and acute non-lymphoblastic leukemia (ANLL)followed by allogeneic stem cell transplantation (AlloSCT).
Condition | Intervention | Phase |
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Acute Lymphoblastic Leukemia Acute Myelogenous Leukemia |
Drug: Clofarabine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Clofarabine in Combination With Cytarabine and Total Body Irradiation Followed by Allogeneic Stem Cell Transplantation in Children With Acute Lymphoblastic Leukemia and Acute Non-Lymphoblastic Leukemia |
Estimated Enrollment: | 40 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Part A: Experimental
Part A will be the dose escalation phase to determine the MTD and/or safe/tolerated dose of clofarabine.
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Drug: Clofarabine
Dose escalation of clofarabine on Days -9, -8, -7, -6, -5: 1 - 30 mg/m2; 2 - 40 mg/m2; 2 - 46 mg/m2; 3 - 52 mg/m2; 4 - 60 mg/m2
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Part B: Experimental
Part B will accrue patients to further define the event free, disease free and overall survival at the MTD or safe/tolerated dose of clofarabine.
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Drug: Clofarabine
Use dose of clofarabine established in Part A to further define event free, disease free and overall survival.
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Ages Eligible for Study: | up to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mitchell S Cairo, MD | 212-305-8316 | mc1310@columbia.edu |
Contact: Lauren Harrison, RN | 978-993-4372 | la313@columbia.edu |
United States, New York | |
Columbia Presbyterian Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Principal Investigator: Mitchell S Cairo, MD | |
Sub-Investigator: Mary Brigid Bradley, MD | |
Sub-Investigator: Prakash Satwani, MD | |
Sub-Investigator: Diane George, MD | |
Sub-Investigator: Monica Bhatia, MD |
Principal Investigator: | Mitchell S Cairo, MD | Columbia University |
Responsible Party: | Columbia University ( Mitchell S. Cairo, MD/ Principal Investigator ) |
Study ID Numbers: | CHNY-06-532, AAAC0918 |
Study First Received: | September 11, 2007 |
Last Updated: | April 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00529360 |
Health Authority: | United States: Institutional Review Board |
Acute Leukemia Allogeneic Stem Cell Transplant Clofarabine Acute Lymphoblastic Leukemia Acute Myelogenous Leukemia |
Clofarabine Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Acute myelogenous leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute |
Leukemia Lymphatic Diseases Lymphoproliferative Disorders Lymphoma Acute myelocytic leukemia Cytarabine |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |