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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00815568
Recruitment Status : Unknown
Verified December 2008 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : December 30, 2008
Last Update Posted : December 30, 2008
Information provided by:
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.

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 Type : Interventional  (Clinical Trial)
Estimated 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 : August 2008
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. progression free survival [ Time Frame: one year ]

Secondary Outcome Measures :
  1. relapse of primary disease, overall survival, and occurrence of acute/chronic GVHD [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00815568

Contact: Dong Hwan Kim +82-2-3410-1768

Korea, Republic of
Dong Hwan Kim Recruiting
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Study Director: Dong Hwan Kim Samsung Medical Center

Responsible Party: Dong Hwan Kim, Dept of Hematology/Medical Oncology, Samsung Medical Center Identifier: NCT00815568     History of Changes
Other Study ID Numbers: 2008-07-020
First Posted: December 30, 2008    Key Record Dates
Last Update Posted: December 30, 2008
Last Verified: December 2008

Keywords provided by Samsung Medical Center:
total body irradiation
conditioning regimen

Additional relevant MeSH terms:
Fludarabine phosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Alkylating Agents
Antineoplastic Agents, Alkylating
Myeloablative Agonists