Feasibility and Efficacy Study of Conditioning Regimen for Allogeneic Hematopoietic Cell Transplantation (HCT) With Fludarabine, Busulfan, and Total Body Irradiation (TBI)

Phase 2

• Conditions: AML; MDS; ALL; CML; Lymphoma
• Interventions: Drug: fludarabine phosphate, busulfan

• Registration Number: NCT00815568
• Lead Sponsor: Samsung Medical Center

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 cyclophosphamide (CY) plus 1200 or 1000 cGy total body irradiation (TBI; CY/TBI) or busulfan (Bu) / CY (BuCy). Unfortunately, such regimens have been associated with significant toxicities, limiting their use to otherwise healthy, relatively young patients.

Recently, Fludarabine plus 4 day dose of busulfan (FluBu4) containing myeloablative regimen has been introduced successfully without increasing transplant-related mortality (TRM). To improve transplant outcomes without increasing the risk of recurrence, Russell et al introduced 400cGy of TBI with antithymocyte (ATG, 4.5mg/Kg) into FluBu4 regimen with successful outcomes.

Study Timeline

• Study Start: 2008-08
• Status Verified: 2008-12
• Study First Submitted: 2008-12-29
• Study First Submitted QC: 2008-12-29
• Last Update Submitted: 2008-12-29
• Study First Posted: 2008-12-30
• Last Update Posted: 2008-12-30
• Primary Completion: 2011-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• 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 Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Regimen	fludarabine phosphate, busulfan	Conditioning regimen for AML with FLT3 mutation, AML/MDS unfavorable cytogenetic risk group, chemorefractory NHL or HD, or ALL/CML

Primary Outcome Measures

Name	Time	Method
progression free survival	one year

Secondary Outcome Measures

Name	Time	Method
relapse of primary disease, overall survival, and occurrence of acute/chronic GVHD	one year

Trial Locations

Locations (1)

Dong Hwan Kim; 🇰🇷 Seoul, Korea, Republic of