Busulfan Plus Cyclophosphamide vs Fludarabine as a Conditioning Regimen (BuCyvsBUFlu)

This study has been completed.
Sponsor:
Information provided by:
Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier:
NCT00774280
First received: October 15, 2008
Last updated: February 10, 2011
Last verified: February 2011
  Purpose
  1. At the same time of registration, patients will be randomized to one of the two conditioning therapy groups; Arm I (intravenous busulfan plus cyclophosphamide; BuCy) or Arm II (intravenous busulfan plus fludarabine; BuFlu).
  2. Randomization will be a stratified permuted-block design. 2.1The patients will be stratified into standard risk vs. high risk group, and related vs. unrelated donor. Standard risk group will be defined as follows: patients with acute leukemia in first remission, CML in chronic phase, and MDS (RA or RARS categories). High risk group will be defined as follows: patients with acute leukemia in relapse or in second or subsequent remission, CML in accelerated or blastic phase, and MDS (CMMoL or RAEB categories).

2.2.Pre-assigned block size is 8.


Condition Intervention Phase
Leukemia
Myelodysplastic Syndrome
Drug: BuCy vs BuFlu
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Comparison of Once-daily Intravenous Busulfan Plus Cyclophosphamide Versus Fludarabine as a Conditioning Regimen for Allogeneic Hematopoietic Cell Transplantation in Leukemia and Myelodysplastic Syndrome

Resource links provided by NLM:


Further study details as provided by Cooperative Study Group A for Hematology:

Primary Outcome Measures:
  • related toxicities of two different conditioning regimens, intravenous once-daily busulfan plus cyclophosphamide (BuCy) vs. fludarabine (BuFlu) for allogeneic hematopoietic cell transplantation (HCT) in leukemia and myelodysplastic syndrome [ Time Frame: 8years ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: May 2002
Study Completion Date: December 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: ArmI(BuCy)
  • Intravenous busulfan (Busulfex®; Orphan Medical, Minnetonka, MN) 3.2 ㎎/㎏ in normal saline 500 ㎖ i.v. over 3 hours on days -7 to -4
  • Cyclophosphamide 60 ㎎/㎏ in D5W 200 ㎖ i.v. over 1-2 hours on days -3 and -2
Drug: BuCy vs BuFlu
Arm 1:BuCy Arm 2:BuFlu
Other Name: busulfan plus cyclophosphamide versus fludarabine
No Intervention: Arm II (BuFlu)
  • Intravenous busulfan 3.2 ㎎/㎏ in normal saline 500 ㎖ i.v. over 3 hours on days -7 to -4.
  • Fludarabine (Fludara®, Schering AG, Berlin, Germany) 30 ㎎/㎡ i.v. over 30 minutes in D5W 100 ㎖ on days -6 to -2
Drug: BuCy vs BuFlu
Arm 1:BuCy Arm 2:BuFlu
Other Name: busulfan plus cyclophosphamide versus fludarabine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with acute leukemia, chronic myelogenous leukemia, myelodysplastic syndrome, and other hematologic malignancies.
  • Patients should have an HLA-identical or one-locus mismatched sibling, family or unrelated donor.
  • Patients should be 15 years of age or older, but younger than 70 years.

Exclusion Criteria:

  • Patients have major illness or organ failure.
  • Patients have a psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible.
  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: NCT00774280

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Cooperative Study Group A for Hematology
Investigators
Principal Investigator: Je-Hwan Lee, Doctor Asan Medical Center
  More Information

Additional Information:
No publications provided by Cooperative Study Group A for Hematology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Je-Hwan Lee, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00774280     History of Changes
Other Study ID Numbers: C-005
Study First Received: October 15, 2008
Last Updated: February 10, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Busulfan
Cyclophosphamide
Fludarabine monophosphate
Fludarabine
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
Antirheumatic Agents
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 24, 2014