Status:
COMPLETED
PK-directed Dose Adjustment of IV Busulfan Conditioning Regimen for Autologous Stem Cell Transplant in Lymphoma Patients
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborating Sponsors:
Center for International Blood and Marrow Transplant Research
Conditions:
Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a study for the outcome and safety of individualized busulfan dosing with cyclophosphamide and etoposide for patients preparing for a stem cell transplant to treat Non-Hodgkin or Hodgkin's Lym...
Detailed Description
Evaluation of progression-free survival, transplant related mortality, overall survival, and overall response rate, in subjects with NHL and HL receiving an IV busulfan-based conditioning regimen with...
Eligibility Criteria
Inclusion
- Subjects with NHL to be included:
- Any subject with NHL that had relapsed or progressed following initial therapy with an anthracycline-based chemotherapy regimen and has achieved a subsequent partial remission (PR) or a complete remission (CR) following a salvage chemotherapy regimen.
- Any subject with NHL that was initially refractory to an anthracycline-based chemotherapy regimen but who has achieved a PR or CR following a salvage chemotherapy regimen.
- Any subject with an initial International Prognostic Index (IPI) score 4-5 who achieved a PR or any CR following an anthracycline-based chemotherapy regimen except subjects with Mantle cell, T cell and Natural Killer (NK) cell pathologies.
- Subjects with Mantle cell, T cell and NK cell lymphoma may be enrolled if they have PR or CR after initial therapy.
- Any subject that has relapsed or progressed following previous autologous HSCT.
- Subjects with HL to be included:
- Any subject with HL that had relapsed or progressed following initial therapy with an multi-drug chemotherapy regimen and has achieved a subsequent PR or a CR following a salvage chemotherapy regimen.
- Any subject with HL that is initially refractory to a multi-drug chemotherapy regimen but who has achieved a PR or CR following a salvage chemotherapy regimen.
- Any subject that has relapsed or progressed following previous autologous HSCT.
Exclusion
- Any subject with chemoresistant disease by demonstration of less than PR to most recent chemotherapy, and any subject with prior treatment history of autologous HSCT or high-dose chemotherapy with stem cell rescue for any medical reason will be excluded.
- Excluded will also be subjects with existing or active central nervous system lymphoma or human immunodeficiency virus related lymphoma, unacceptable organ function, or uncontrolled infections.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT00948090
Start Date
January 1 2010
End Date
June 1 2013
Last Update
July 31 2014
Active Locations (42)
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1
University of Alabama in Birmingham
Birmingham, Alabama, United States, 35294
2
Arizona Cancer Center
Tucson, Arizona, United States, 85719
3
Alta Bates Summit Medical Center
Berkeley, California, United States, 94704
4
Scripps Clinic
La Jolla, California, United States, 92037