Busulfan Plus Cyclophosphamide vs Fludarabine as a Conditioning Regimen for Allogeneic Hematopoietic Cell Transplantation in Leukemia and Myelodysplastic Syndrome - Full Text View

Sponsored by:	Cooperative Study Group A for Hematology
Information provided by:	Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier:	NCT00774280

Purpose

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

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

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Cyclophosphamide Fludarabine Fludarabine monophosphate Busulfan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
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

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: 2008 ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	May 2002
Estimated Study Completion Date:	December 2008
Primary Completion Date:	May 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
BuCy: Active Comparator 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
BuFlu: Active Comparator 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

Detailed Description:

1.1 Compare the regimen 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.

1.2 The other end points of the study include incidence of GVHD, non-relapse mortality, event-free survival, overall survival, and relapse incidence.

Eligibility

Ages Eligible for Study:	15 Years to 69 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 should not have major illness or organ failure.
Patients must not have a psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible.
Patients must not be in pregnancy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774280

Contacts

Contact: Je-Hwan Lee, Doctor

82-2-3010-3218

jhlee3@amc.seoul.kr

Locations

Korea, Republic of
Asan Medical Center	Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Yae-Eun Jang, Nurse

Sponsors and Collaborators

Cooperative Study Group A for Hematology

Investigators

Principal Investigator:

Je-Hwan Lee, Doctor

Asan Medical Center

More Information

Responsible Party:	Asan Medical Center ( Je-Hwan Lee )
Study ID Numbers:	C-005
Study First Received:	October 15, 2008
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00774280
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Myelodysplastic syndromes
Leukemia
Preleukemia
Precancerous Conditions
Hematologic Diseases
Busulfan

Myelodysplasia
Myelodysplastic Syndromes
Fludarabine
Fludarabine monophosphate
Cyclophosphamide
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Disease
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

Neoplasms
Pathologic Processes
Syndrome
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009