NCT00774527

Brief Summary

Randomized comparison of cyclophosphamide versus reduced-dose cyclophosphamide plus fludarabine in addition to anti-thymocyte globulin for the conditioning therapy in allogeneic hematopoietic cell transplantation for bone marrow failure syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_3

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

March 1, 2003

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

February 17, 2011

Status Verified

February 1, 2011

Enrollment Period

6.9 years

First QC Date

October 12, 2008

Last Update Submit

February 16, 2011

Conditions

Bone Marrow Failure Syndromes

Outcome Measures

Primary Outcomes (1)

  • Occurrence of regimen related toxicities

    1.1 Compare the regimen related toxicities of two different conditioning regimens, cyclophosphamide (Cy)+anti-thymocyte globulin (ATG) (Cy-ATG) vs. reduced dose of Cy+fludarabine (Flu)+ATG (Cy-Flu-ATG) after allogeneic hematopoietic cell transplantation (allo-HCT).

    7 years

Secondary Outcomes (1)

  • Secondary end point will be the occurrence of engraftment failure (primary and secondary)

    7years

Study Arms (1)

ArmI(CyATG)

NO INTERVENTION

•Conditioning therapy will start on day -5 in patients who are randomized to receive Cy+ATG. Hydration with 0.45% NaCl at 6 liters/24 hours will be started on day -5. Cy 50 mg/kg in D5W 200 ml i.v. over 1-2 hours on days -5 to -2 by pump through a central venous catheter

Drug: Cyclophosphamide-fludarabine-anti thymocyte globulin

Interventions

Cyclophosphamide-fludarabine-anti thymocyte globulinDRUG

* Cyclophosphamide 50 mg/kg in D5W 200 ml i.v. over 1-2 hours on days -5 to -2 by pump through a central venous catheter. * Fludarabine 30 mg/m2 will be infused intravenously over 30 minutes in D5W 100 ml for 5 consecutive days (days -6 to -2). * Thymoglobuline 3 mg/kg in N/S 500-800 mL (less than 0.5 mg/mL) or lymphoglobuline 15 mg/kg in N/S 500-800 mL (less than 2 mg/mL) iv daily at 8 am on days -4 to -2.

Also known as: CYCLOPHOSPHAMIDE,FLUDARA,ANTI-THYMOCYTE GLOBULINE
ArmI(CyATG)

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with bone marrow failure syndrome.
  • Written informed consent must be obtained from the patients and donors.
  • Patients should have an HLA-identical or one-locus mismatched sibling, family or unrelated donor who is 60 years or less.
  • Patients should be 15 years of age or older, but younger than 60 years.
  • The performance status of the patients should be 70 or over by Karnofsky performance scale (see Appendix I).
  • Patients should not have major illness or organ failure.
  • Patients must have adequate hepatic function (bilirubin less than 2 mg/dl, AST and ALT less than three times the upper normal limit).
  • Patients must have adequate renal function (creatinine less than 2.0 mg/dl).
  • Patients must have adequate cardiac function (ejection fraction \> 45% on MUGA scan).
  • Patients must not have a psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlikely, and making informed consent impossible.
  • Patients must not be in pregnancy.

You may not qualify if:

  • Patients should have major illness or organ failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Links

MeSH Terms

Conditions

Bone Marrow Failure Disorders

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Kyoo-Hyung 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 12, 2008

First Posted

October 17, 2008

Study Start

March 1, 2003

Primary Completion

February 1, 2010

Study Completion

January 1, 2011

Last Updated

February 17, 2011

Record last verified: 2011-02

Locations

KR(1)