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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00815568

Enrollment

114

Registered

2008-12-30

Start date

2008-08-31

Completion date

2012-12-31

Last updated

2008-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ALL, AML, CML, Lymphoma, MDS

Keywords

fludarabine, busulfan, total body irradiation, conditioning regimen

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.

Interventions

DRUGfludarabine phosphate, busulfan

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)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
progression free survival	one year

Secondary

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

Countries

South Korea

Contacts

Primary ContactDong Hwan Kim

drkiim@medimail.co.kr+82-2-3410-1768

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026