Feasibility and Efficacy Study of Conditioning Regimen for Allogeneic Hematopoietic Cell Transplantation (HCT) With Fludarabine, Busulfan, and Total Body Irradiation (TBI)
Prospective Phase II Clinical Trial of Myeloablative Conditioning Regimen With Fludarabine and Busulfan Plus 400 cGy Total Body Irradiation for Hematologic Malignancies
1 other identifier
interventional
114
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2008
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 29, 2008
CompletedFirst Posted
Study publicly available on registry
December 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedDecember 30, 2008
December 1, 2008
3.3 years
December 29, 2008
December 29, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
progression free survival
one year
Secondary Outcomes (1)
relapse of primary disease, overall survival, and occurrence of acute/chronic GVHD
one year
Study Arms (1)
Regimen
EXPERIMENTALConditioning regimen for AML with FLT3 mutation, AML/MDS unfavorable cytogenetic risk group, chemorefractory NHL or HD, or ALL/CML
Interventions
Fludarabine ( 30mg/m2, iv, D-7\~D-2) Busulfan (3.2mg/kg, iv, D-6\~D-3) Total body irradiation (200cGy/day, D-2,-1)
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dong Hwan Kim
Seoul, 135-710, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dong Hwan Kim
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 29, 2008
First Posted
December 30, 2008
Study Start
August 1, 2008
Primary Completion
December 1, 2011
Study Completion
December 1, 2012
Last Updated
December 30, 2008
Record last verified: 2008-12