NCT00563589

Brief Summary

There is a significant (50-80%) risk of acute graft-versus-host disease(GVHD) and early mortality (30%) associated with high risk stem cell transplantation (SCT) such as that from a matched unrelated donor or HLA-mismatch sibling. Mycophenolate mofetil (MMF) has been shown to be an effective and safe immunosuppressant in the prevention and treatment of rejection after solid organ transplantation. Its role in acute GVHD prophylaxis in high risk SCT will be investigated in this clinical trial.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

July 7, 2010

Status Verified

July 1, 2010

First QC Date

November 21, 2007

Last Update Submit

July 6, 2010

Conditions

Graft vs Host DiseaseHematopoietic Stem Cell Transplantation

Keywords

Acute graft-versus-host disease post high risk allogeneic stem cell transplantation

Outcome Measures

Primary Outcomes (2)

  • acute GVHD incidence and grading

    100 Days

  • chronic GVHD incidence

    3 Years

Secondary Outcomes (3)

  • Mortality, GVHD-related and all cause

    3 Years

  • Symptomatic side effects attributed to MMF

    60 Days

  • Date of engraftment

    Date of engraftment

Interventions

mycophenolate mofetil, methotrexate, cyclosporinDRUG
Methotrexate and cyclosporinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing allogeneic SCT with high risk of acute GVHD, ie. from matched unrelated donor or one HLA-locus mismatch sibling

You may not qualify if:

  • known allergy to mycophenolate mofetil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Mycophenolic AcidMethotrexateCyclosporine

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Lawrence SY Ma, Dr

    Department of Medicine/ Haematology and Oncology, Queen Mary Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Winnie WW Cheung, Dr

CONTACT

(852) 2855 3111cheungww@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 26, 2007

Study Start

August 1, 2003

Study Completion

December 1, 2008

Last Updated

July 7, 2010

Record last verified: 2010-07

Locations

CN(1)