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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute ESP Pharma |
Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00363467 |
During the pre-transplantation phase (following completion of consolidation chemotherapy), patients will begin to receive G-CSF at 10 mcg/kg twice daily; leukapheresis will also be given until a target goal for recipient body weight is obtained, or up to a maximum of 5 days. Conditioning/Preparative therapy will follow PBSC collection for up to 30 days with Busulfan IV daily x 4 days; subsequent doses will be adjusted based on pharmacokinetic (plasma level)monitoring. Following 1 day of rest, stem cell reinfusion will begin with supportive care. During follow-up, patients will be monitored out to 730 days.
Condition | Intervention | Phase |
Acute Myeloid Leukemia (AML) |
Drug: G-CSF Drug: Leukapheresis Drug: Busulfan Procedure: Stem cell reinfusion |
Phase I |
MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic |
ChemIDplus related topics: | Granulocyte colony-stimulating factor Busulfan |
Study Type: | Interventional |
Study Design: | Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study of Intravenous, Targeted-Dose Busulfan Monotherapy as Conditioning for Autologous Hematopoietic Progenitor Cell Transplantation in High-Risk AML |
Estimated Enrollment: | 60 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Pre- Transplantation Phase -
Transplantation Phase
a. Conditioning/Preparative therapy - up to 30 days following PBSC collection, patients will begin conditioning therapy with Busulfan IV daily x 4 days (transplantation days -5,-4,-3,-2). The day -5 and -4 dose will be 130mg/m2; subsequent doses will be adjusted based on pharmacokinetic monitoring.
Supportive care
During follow-up, patients will be seen at least weekly for the first month and there after periodically out to 730 days posttransplant. The following medical procedures will be done:
Ages Eligible for Study: | 56 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
General Inclusion Criteria:
Disease Specific Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |||||
H. Lee Moffitt Cancer Center & Research Institute | |||||
Tampa, Florida, United States, 33612 |
H. Lee Moffitt Cancer Center and Research Institute |
ESP Pharma |
Principal Investigator: | Jeffrey E Lancet, MD | H. Lee Moffitt Cancer Center and Research Institute |
Moffiitt Cancer Center Clinical Trials Website 
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Responsible Party: | H. Lee Moffitt Cancer Center & Research Institute ( Jeffrey Lancet, MD ) |
Study ID Numbers: | MCC-14604 |
First Received: | August 10, 2006 |
Last Updated: | July 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00363467 |
Health Authority: | United States: Food and Drug Administration |
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