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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00815568
First received: December 29, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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 Intervention Phase
AML
MDS
ALL
CML
Lymphoma
Drug: fludarabine phosphate, busulfan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • progression free survival [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • relapse of primary disease, overall survival, and occurrence of acute/chronic GVHD [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 114
Study Start Date: August 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815568

Contacts
Contact: Dong Hwan Kim +82-2-3410-1768 drkiim@medimail.co.kr

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

No publications provided

Responsible Party: Dong Hwan Kim, Dept of Hematology/Medical Oncology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00815568     History of Changes
Other Study ID Numbers: 2008-07-020
Study First Received: December 29, 2008
Last Updated: December 29, 2008
Health Authority: South Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Busulfan
Fludarabine monophosphate
Fludarabine
Vidarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 22, 2014