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| Sponsor: | New York Medical College |
|---|---|
| Collaborator: |
Genzyme |
| Information provided by (Responsible Party): | Mitchell Cairo, New York Medical College |
| 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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: Part A
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
Other Name: Clolar®
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Experimental: Part B
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.
Other Name: Clolar®
|
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 | 914-594-3650 | mitchell_cairo@nymc.edu |
| Contact: Lauren Harrison, MSN | 978-993-4372 | lauren_harrison@nymc.edu |
| United States, New York | |
| Columbia Presbyterian Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Principal Investigator: Prakash Satwani, MD | |
| Principal Investigator: | Mitchell S Cairo | New York Medical College |
More Information
| Responsible Party: | Mitchell Cairo, Principal Investigator, New York Medical College |
| ClinicalTrials.gov Identifier: | NCT00529360 History of Changes |
| Other Study ID Numbers: | L 9471 |
| Study First Received: | September 11, 2007 |
| Last Updated: | September 22, 2011 |
| 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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Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Clofarabine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |