NCT00774280

Brief Summary

  1. 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at below P25 for phase_3 leukemia

Timeline
Completed

Started May 2002

Typical duration for phase_3 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 14, 2011

Status Verified

February 1, 2011

Enrollment Period

7.5 years

First QC Date

October 15, 2008

Last Update Submit

February 10, 2011

Conditions

LeukemiaMyelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

    8years

Study Arms (2)

ArmI(BuCy)

NO INTERVENTION

* 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 II (BuFlu)

NO INTERVENTION

* 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

Interventions

BuCy vs BuFluDRUG

Arm 1:BuCy Arm 2:BuFlu

Also known as: busulfan plus cyclophosphamide versus fludarabine
Arm II (BuFlu)ArmI(BuCy)

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (1)

  • Lee JH, Joo YD, Kim H, Ryoo HM, Kim MK, Lee GW, Lee JH, Lee WS, Park JH, Bae SH, Hyun MS, Kim DY, Kim SD, Min YJ, Lee KH. Randomized trial of myeloablative conditioning regimens: busulfan plus cyclophosphamide versus busulfan plus fludarabine. J Clin Oncol. 2013 Feb 20;31(6):701-9. doi: 10.1200/JCO.2011.40.2362. Epub 2012 Nov 5.

    PMID: 23129746DERIVED

Related Links

MeSH Terms

Conditions

LeukemiaMyelodysplastic Syndromes

Interventions

Busulfan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Intervention Hierarchy (Ancestors)

Butylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Je-Hwan Lee, Doctor

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

October 15, 2008

First Posted

October 17, 2008

Study Start

May 1, 2002

Primary Completion

November 1, 2009

Study Completion

December 1, 2010

Last Updated

February 14, 2011

Record last verified: 2011-02

Locations

KR(1)