Clinical Trials Logo
  1. Home
  2. Graft vs Host Disease
  3. NCT00563589
  4. Details
NCT00563589 Clinical Trial

Mycophenolate Mofetil for the Prophylaxis of Graft-versus-host Disease in High Risk Allogeneic Stem Cell Transplantation

Graft vs Host Disease Clinical Trial

Official title:
A Randomized Single-center Trial of Mycophenolate Mofetil for the Prophylaxis of Graft-versus-host Disease in High Risk Allogeneic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00563589
Other study ID # IRB 03-09 R/353
Secondary ID HARECCTR0500036
Status Recruiting
Phase N/A
First received November 21, 2007
Last updated July 6, 2010
Start date August 2003
Est. completion date December 2008

Study information
Verified date July 2010
Source Hospital Authority, Hong Kong
Contact Winnie WW Cheung, Dr
Phone (852) 2855 3111
Email cheungww@hotmail.com
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- known allergy to mycophenolate mofetil

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• mycophenolate mofetil, methotrexate, cyclosporin

• Methotrexate and cyclosporin

Locations
Country Name City State
China Queen Mary Hospital Hong Kong

Sponsors (2)
Lead Sponsor Collaborator
Hospital Authority, Hong Kong Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary acute GVHD incidence and grading 100 Days
Primary chronic GVHD incidence 3 Years
Secondary Mortality, GVHD-related and all cause 3 Years
Secondary Symptomatic side effects attributed to MMF 60 Days
Secondary Date of engraftment Date of engraftment
See also
  Status Clinical Trial Phase
Recruiting NCT06080490 - Tacrolimus Blood Concentration and Transplant-related Outcomes in Pediatric HSCT Recipients
Completed NCT00001637 - Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults Phase 2
Withdrawn NCT04728646 - Evaluation of Dextenza in Patients With Ocular GVHD and Effects on Ocular Surface Disease Outcomes Phase 4
Suspended NCT01972438 - A Randomized, Controlled, Double-masked, Clinical Trial of Autologous Serum Eye Drops for Severe Ocular Chronic Graft-versus-host Disease (GVHD) in Hematopoietic Stem Cell Transplant (HSCT) Patients Phase 1/Phase 2
Completed NCT01221766 - Impact of Adnexal Involvement of the Severity and Prognosis of Chronic Graft-versus-Host Disease N/A
Recruiting NCT01764100 - Mesenchymal Stromal Cells (MSCs) for the Treatment of Graft Versus Host Disease (GVHD) Phase 1
Completed NCT00760981 - A Pilot Study of Imatinib Mesylate in Steroid Refractory Chronic Graft Versus Host Disease Phase 1
Terminated NCT00298324 - Myfortic - Treatment for Extensive cGvHD Phase 3
Completed NCT00224874 - Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302) Phase 2
Completed NCT00023491 - Potential of Transplanted Stem Cells to Mature Into Salivary Gland and Cheek Cells N/A
Completed NCT00023530 - Blood and Marrow Transplant Clinical Research Network N/A
Recruiting NCT05111834 - IRENE-G Study: Impact of Resistance Exercise and Nutritional Endorsement on GvHD Symptoms N/A
Completed NCT02841995 - A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease Phase 2
Recruiting NCT06143501 - Alterations in Intestinal Microbiota, Metabolites, and Immune Cells in Allo-HSCT
Recruiting NCT04622956 - GVHD Prophylaxis With Methotrexate in Haploidentical HCT Using Posttransplant Cyclophosphamide Phase 1/Phase 2
Recruiting NCT03340155 - Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases N/A
Recruiting NCT03836690 - Transfer of Effector Memory T Cells (Tem) Following Allogeneic Stem Cell Transplantation Phase 1
Not yet recruiting NCT06450925 - Vitamin A Supplementation in Allogeneic Stem Cell Transplantation. N/A
Not yet recruiting NCT02506231 - The Effect of Folinic Acid Rescue Following MTX GVHD Prophylaxis on Regimen Related Toxicity and Transplantation Outcome Phase 2/Phase 3
Recruiting NCT01042509 - Combination of Alemtuzumab and Rituximab at Low-doses in Refractory Chronic Graft-Versus-Host Disease N/A

External Links