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

Lymphoma Clinical Trial

Official title:

Prospective Phase II Clinical Trial of Myeloablative Conditioning Regimen With Fludarabine and Busulfan Plus 400 cGy Total Body Irradiation for Hematologic Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00815568
• Other study ID #: 2008-07-020
• Status: Recruiting
• Phase: Phase 2
• First received: December 29, 2008
• Last updated: December 29, 2008
• Start date: August 2008
• Est. completion date: December 2012

Study information

• Verified date: December 2008
• Source: Samsung Medical Center
• Contact: Dong Hwan Kim
• Phone: +82-2-3410-1768
• Email: drkiim[@]medimail.co.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ALL
• AML
• CML
• Lymphoma
• MDS

Intervention

Drug:
• fludarabine 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)

Locations

Country	Name	City	State
Korea, Republic of	Dong Hwan Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival		one year	No
Secondary	relapse of primary disease, overall survival, and occurrence of acute/chronic GVHD		one year	No