Status:
UNKNOWN
Feasibility and Efficacy Study of Conditioning Regimen for Allogeneic Hematopoietic Cell Transplantation (HCT) With Fludarabine, Busulfan, and Total Body Irradiation (TBI)
Lead Sponsor:
Samsung Medical Center
Conditions:
AML
MDS
Eligibility:
All Genders
15-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the OS, RFS, and TRM after HCT with low-dose total body irradiation, fludarabine, and busulfan conditioning.
Detailed Description
Conventional allogeneic hematopoietic cell transplantation (HCT) for patients with hematological malignancies involves conditioning with high doses of systemic chemo/radiation therapy such as cyclopho...
Eligibility Criteria
Inclusion
- At least 15 years old and not more than 65 years old.
- ECOG performance status 0-2.
- Patients with AML or MDS with intermediate/unfavorable cytogenetics.
- Patients with ALL and CML ineligible for Cy/TBI conditioning.
- Patients with NHL or HD eligible to myeloablative HCT.
- Patients receiving unrelated BMT for AML, MDS, ALL, CML, NHL or HD.
- Consent form signed and dated prior to study specific procedures.
- Subject able to comply with the scheduled follow-up and with the management of toxicities.
Exclusion
- \-
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00815568
Start Date
August 1 2008
End Date
December 1 2012
Last Update
December 30 2008
Active Locations (1)
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1
Dong Hwan Kim
Seoul, South Korea, 135-710