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| Sponsor: | Columbia University |
|---|---|
| Collaborator: |
Genzyme |
| Information provided by: | Columbia University |
| ClinicalTrials.gov Identifier: | NCT00529360 |
Purpose
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 |
|---|---|---|
|
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 |
|---|---|
|
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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Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| 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: | August 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00529360 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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Acute Leukemia Allogeneic Stem Cell Transplant Clofarabine Acute Lymphoblastic Leukemia Acute Myelogenous Leukemia |
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Clofarabine Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents Leukemia, Myeloid |
Leukemia, Myeloid, Acute Pharmacologic Actions Leukemia Lymphatic Diseases Neoplasms Therapeutic Uses Lymphoproliferative Disorders |