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Sponsors and Collaborators: |
Indiana University School of Medicine Genzyme |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00477542 |
This is a phase trial to determine the maximum tolerated dose (MTD) of clofarabine in a combination with a myeloablative dose of busulfan. This is an initial step in developing a novel myeloablative preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT). While this phase I trial will initially develop the regimen in patients with refractory disease, it is expected that it will find its best application in patients with less advanced disease
Condition | Intervention | Phase |
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Hematologic Malignancies |
Drug: clofarabine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Trial of Myeloablative Conditioning Using Clofarabine and High-Dose Busulfan for Patients With Refractory Hematological Malignancies Undergoing Allogeneic HSCT |
Estimated Enrollment: | 18 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Cohort- n- Clofarabine (mg/m2/day)
-1 3-10 20
All patients will receive the same dose of busulfan. The dose of clofarabine will be escalated in successive cohorts of patients. Using a standard dose escalation design, successive cohorts of 3 patients will be treated with escalating doses of clofarabine. At the MTD (or highest dose-level if the MTD is not reached), the cohort will be expanded to 10 patients to better investigate correlative studies and give some preliminary idea of efficacy.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Documentation of disease. Patients must have one of the following disease types:
Acute myeloid leukemia (AML) with either:
Acute lymphoblastic leukemia (ALL) with one of the following criteria:
Chronic myelogenous leukemia (CML) with one of the following criteria:
Patients with aggressive non-Hodgkin's lymphoma (NHL), including diffuse large cell lymphoma, mediastinal B-cell lymphoma, transformed lymphoma, mantle cell lymphoma, and peripheral T cell lymphoma, who also have one of the following criteria:
Required baseline laboratory values:
Exclusion Criteria:
Contact: Lisa Wood, RN | 317-274-1781 | llwood@iupui.educ |
Contact: Sherif Farag, MD, PhD | 317-274-0843 | ssfarag@iupui.edu |
United States, Indiana | |
Indiana University Cancer Center | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Principal Investigator: Sherif Farag, MD, PhD |
Principal Investigator: | Sherif Farag, MD, PhD | Indiana University |
Responsible Party: | Indiana University Cancer Center ( Sherif Farag, MD, PhD/ Principal Investigator ) |
Study ID Numbers: | 0704-30 IUCRO-0186 |
Study First Received: | May 21, 2007 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00477542 |
Health Authority: | United States: Institutional Review Board |
Clofarabine allogeneic HSCT refractory malignancies |
Clofarabine Hematologic Neoplasms Hematologic Diseases Busulfan |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |