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| Sponsor: | University of Chicago |
|---|---|
| Collaborator: |
Genzyme |
| Information provided by: | University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00724009 |
Purpose
For relapsed and refractory leukemia patients induction chemotherapy prior to initiating a conditioning regimen will decrease residual leukemia (as measured by bone marrow leukemia blast percentage) at the time of HCT. This should lead to reduced relapse while still maintaining low transplant related mortality.
| Condition | Intervention |
|---|---|
|
Leukemia |
Drug: Clofarabine |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment |
| Official Title: | Clofarabine Bone Marrow Cytoreduction : Feasibility of Induction as a Bridge to Allogeneic Stem Cell Transplantation for Patients With Relapsed or Refractory Acute Leukemias, Myelodysplastic Syndromes, and Advanced Myeloproliferative Diseases. |
| Estimated Enrollment: | 27 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate hepatobiliary function as indicated by the following laboratory values:
Exclusion Criteria:
Contacts and Locations| Contact: Wendy Stock, MD | wstock@medicine.bsd.uchicago.edu | |
| Contact: Paula Del Cerro, RN, OCN | 773-702-2070 |
| United States, Illinois | |
| The University of Chicago hospitals | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Principal Investigator: Wendy Stock, MD | |
| Sub-Investigator: Frederick Locke, MD | |
| Principal Investigator: | Wendy Stock, MD | University of Chicago |
More Information
| Responsible Party: | The University of Chicago ( Wendy Stock, MD, Professor ) |
| Study ID Numbers: | 15809B |
| Study First Received: | July 25, 2008 |
| Last Updated: | March 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00724009 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Clofarabine Leukemia Neoplasms Neoplasms by Histologic Type Antineoplastic Agents |
Hematologic Diseases Therapeutic Uses Myelodysplastic Syndromes Bone Marrow Diseases Pharmacologic Actions |