Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT)
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First Received Date ICMJE | August 3, 2006 | ||||||||
Last Updated Date | November 1, 2011 | ||||||||
Start Date ICMJE | August 2005 | ||||||||
Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Define the maximally tolerated AUC and dose (AUC) limiting toxicities for IV busulfan in the setting of busulfan/fludarabine conditioning prior to allogeneic stem cell transplantation [ Time Frame: Day 100 Post Transplant ] [ Designated as safety issue: Yes ] | ||||||||
Original Primary Outcome Measures ICMJE |
Define the maximally tolerated AUC and dose (AUC) limiting toxicities for IV busulfan in the setting of busulfan/fludarabine conditioning prior to allogeneic stem cell transplantation | ||||||||
Change History | Complete list of historical versions of study NCT00361140 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT) | ||||||||
Official Title ICMJE | Busulfan Dose Escalation Study Based on AUC in the Setting of Busulfan/Fludarabine Conditioning Prior to Allogeneic Hematopoietic Cell Transplantation (HCT) | ||||||||
Brief Summary | Pre-transplant conditioning will include Fludarabine and dose-escalated Busulfan on days -6, -5, -4, and -3. Daily treatment doses will be adjusted to achieve target AUCs (area under the plasma concentration time curve). Day 0 is the day of hematopoietic progenitor cell reinfusion. Supportive care will be based on institutional guidelines. Blood samples will be collected for dose modification based on the AUC levels. Dose escalation will proceed to determine the maximally tolerated level or AUC to evaluate the potential therapeutic benefit of higher doses of busulfan. |
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Detailed Description | Patients will receive anti-seizure prophylaxis beginning on day -7. Pre-transplant conditioning will include Fludarabine and dose-escalated Busulfan on days -6, -5, -4, and -3. Daily treatment doses will be adjusted to achieve target AUCs (area under the plasma concentration time curve). Day 0 is the day of hematopoietic progenitor cell reinfusion. Supportive care will be based on institutional guidelines. In an effort to prevent hepatotoxicity, ursodiol will be given to patients. During chemotherapy patients will not receive concurrent metronidazole, itraconazole, or be given acetaminophen. Blood samples will be collected at specific times after Dose 1 and Dose 4 and dose modification will be determined or based on the desired AUC levels. Doses 3 and/or 4 will be adjusted to achieve an average daily Busulfan AUC over the 4 treatment days. Dose escalation will proceed through 3 dose levels to determine the maximally tolerated level or AUC to evaluate the potential therapeutic benefit of higher doses of busulfan. Graft assessment, processing, and characterization will be done as per institutional guidelines. Donor-recipient chimerism (two genetically distinct types of blood cells) will be characterized by samples obtained pre-transplant and on days 30+/- 7, 90+/-7 and 360+/-30 post-transplant. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 4 | ||||||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||
Estimated Enrollment ICMJE | 60 | ||||||||
Estimated Completion Date | December 2011 | ||||||||
Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria - Recipient:
Exclusion Criteria - Recipient:
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Gender | Both | ||||||||
Ages | 16 Years to 65 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00361140 | ||||||||
Other Study ID Numbers ICMJE | MCC-14178 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
Responsible Party | H. Lee Moffitt Cancer Center and Research Institute | ||||||||
Study Sponsor ICMJE | H. Lee Moffitt Cancer Center and Research Institute | ||||||||
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Information Provided By | H. Lee Moffitt Cancer Center and Research Institute | ||||||||
Verification Date | November 2011 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |