MDACC Study Summary 2004-0711 (Archived)

Study Summary
No. 2004-0711:.......Other Studies......Daniel Couriel......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	2004-0711

Study Title:	Multicenter Phase III Double-Blind Clinical Trial to Evaluate the Efficacy of Mycophenolate Mofetil Added to Prednisone plus Cyclosporine or Tacrolimus for Treatment of Newly Diagnosed Chronic Graft-versus-Host Disease

Physician

New Patient Referral



Name:	Daniel Couriel	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Stem Cell Transplantation and Cellular Therapy	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6100 Contact us about clinical trials

General Information



Disease Group:	Other Studies	Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	weekly, biweekly or monthly depending on the patient.

Treatment Agents:	Mycophenolate Mofetil Prednisone	Home Care:	No

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Patients are treated on an outpatient basis.


Description/ Intervention:	The goal of this clinical research study is to learn if mycophenolate mofetil (MMF) given with either prednisone and cyclosporine or prednisone and tacrolimus is an effective treatment of chronic GVHD. The safety of these combination treatments will also be studied.

Study Objectives / Outcomes

The objectives of this study are 1) to test whether the addition of mycophenolate mofetil (MMF) improves the efficacy of prednisone plus cyclosporine or tacrolimus for treatment of newly diagnosed chronic GVHD, and 2) to assess whether the addition of MMF improves quality of life.

Study Status Information



Study Activation / Registration Date:	06/08/2005

IRB Review and Approval Date:	03/16/2005

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	230, 2 years enrollment, 27 months follow-up

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Biopsy-confirmed diagnosis of chronic GVHD with indication for systemic immunosuppressive treatment, with any type of donor, hematopoietic cell graft or conditioning regimen

2) Patient or guardian able and willing to provide informed consent

3) Stated willingness of a female patient to use two forms of contraception, if fertile and not abstinent (FDA requirement)

4) Stated willingness of a patient to comply with study procedures and reporting requirements

5) Stated willingness of the physician most involved in management of chronic GVHD to comply with study procedures and reporting requirements

Exclusion Criteria:

1) Fungal infection with no radiographic evidence of improvement during continued antifungal therapy at the time of enrollment

2) CMV pneumonia without major radiographic improvement or CMV infection with no reduction of antigenemia or viral load during continued antiviral therapy at the time of enrollment

3) Active disseminated VZV infection at the time of enrollment. Patients may be enrolled after all lesions have crusted

4) Inability to tolerate oral administration of medications at the time of enrollment

5) Lactose intolerant children who are too young to swallow capsules.

6) Known hypersensitivity or allergy to MMF

7) Melena or frank blood per rectum at the time of enrollment

8) Gastrointestinal ulceration known to be present at the time of enrollment

9) Absolute neutrophil count (ANC) < 1500/microliter at the time of enrollment

10) Any systemic immunosuppressive treatment other than glucocorticoids, cyclosporine or tacrolimus at the time of enrollment. Patients who received MMF for prevention or treatment of acute GVHD may be enrolled if administration of MMF was discontinued at least 2 weeks before the diagnosis of chronic GVHD was made.

11) Treatment with prednisone (or equivalent ) at doses higher than 1.0 mg/kg/day at the time of enrollment

12) Any prior treatment for chronic GVHD

13) Bronchiolitis obliterans known to be present as manifestation of chronic GVHD at the time of enrollment, since this would preclude taper of glucocorticoid treatment

14) Persistent or recurrent malignancy at the time of enrollment, including histopathologic evidence of myeloma or lymphoma. Patients with bcr/abl detected by PCR assay as the only evidence of persistent chronic myeloid leukemia may be enrolled.

15) Pregnancy or breast feeding at the time of enrollment

16) Hospitalization at the time of enrollment. Treatment with prednisone as described below in Sections 9 and 11 may begin during hospitalization, but randomization must be deferred until after the patient has been discharged form the hospital.

Links

Registration Number: NCT00089141
Study Information on Clinical Trials Registry (clinicaltrials.gov)