Tacrolimus and Mycophenolate Mofetil in Preventing Acute Graft-Versus-Host Disease in Patients With Advanced Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplantation
Study Details
Study Description
Brief Summary
RATIONALE: Tacrolimus and mycophenolate mofetil may be an effective treatment for graft-versus-host disease caused by donor stem cell transplantation.
PURPOSE: This phase II trial is studying how well giving tacrolimus together with mycophenolate mofetil works in preventing acute graft-versus-host disease in patients who are undergoing donor stem cell transplantation for advanced hematologic cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
Primary
- Determine the efficacy of tacrolimus and mycophenolate mofetil in preventing acute graft-vs-host disease in patients with advanced hematologic malignancies undergoing allogeneic peripheral blood stem cell transplantation.
Secondary
- Determine the safety of this regimen in these patients.
OUTLINE: This is a non-randomized study.
Patients receive tacrolimus IV continuously or orally twice daily on days -1 to 60 followed by a taper to day 180. Patients also receive mycophenolate mofetil IV over 2 hours or orally twice daily on days 0-60 followed by a taper to day 180. Treatment is discontinued at day 180 in the absence of graft-vs-host disease.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 5-25 patients will be accrued for this study.
Study Design
Outcome Measures
Primary Outcome Measures
- Efficacy []
Secondary Outcome Measures
- Safety []
- Area under the curve of plasma mycophenolic acid []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Diagnosis of 1 of the following hematologic malignancies:
-
Acute myeloid leukemia beyond first complete remission (CR1)
-
Acute lymphoblastic leukemia beyond CR1
-
Chronic myelogenous leukemia in second chronic phase, accelerated phase, or blastic phase
-
Non-Hodgkin's lymphoma beyond CR2
-
Hodgkin's lymphoma beyond CR2
-
Multiple myeloma (any stage)
-
Myelodysplastic syndromes beyond refractory anemia (including chronic myelomonocytic leukemia)
-
Any refractory hematologic malignancy
-
Advanced disease
-
Scheduled for transplantation of mobilized allogeneic peripheral blood stem cells
-
Genotypically HLA-identical stem cell donor available
PATIENT CHARACTERISTICS:
Age
- 65 and under
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
-
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
-
SGOT and SGPT ≤ 2.0 times ULN
Renal
- Creatinine clearance ≥ 60 mL/min
Pulmonary
-
No acute pulmonary infection by chest x-ray
-
No severe hypoxemia (partial O_2 < 70% of predicted) AND DLCO < 70% of predicted
-
No mild hypoxemia (partial O_2 < 80% of predicted) AND DLCO < 60% of predicted
Other
-
Not pregnant or nursing
-
Negative pregnancy test
-
No active systemic infection not controlled with antimicrobial therapy
-
HIV negative (HIV-1 or other virus)
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent T-cell depleted hematopoietic stem cell graft
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fred Hutchinson Cancer Research Center | Seattle | Washington | United States | 98109-1024 |
Sponsors and Collaborators
- Fred Hutchinson Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Richard Nash, MD, Fred Hutchinson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1893.00
- FHCRC-1893.00
- CDR0000391026