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

Sponsor

Samsung Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00815568

Collaborator

(none)

114

Enrollment

Location

Arm

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
AML MDS ALL CML Lymphoma	Drug: fludarabine phosphate, busulfan	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

114 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2011

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Regimen Conditioning regimen for AML with FLT3 mutation, AML/MDS unfavorable cytogenetic risk group, chemorefractory NHL or HD, or ALL/CML	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) Other Names: Fludarabine (Fludara®, Berlex Laboratories, Richmond, CA)

Arm

Intervention/Treatment

Experimental: Regimen

Conditioning regimen for AML with FLT3 mutation, AML/MDS unfavorable cytogenetic risk group, chemorefractory NHL or HD, or ALL/CML

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)

Other Names:

Fludarabine (Fludara®, Berlex Laboratories, Richmond, CA)

Outcome Measures

Primary Outcome Measures

progression free survival [one year]

Secondary Outcome Measures

relapse of primary disease, overall survival, and occurrence of acute/chronic GVHD [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.