Tacrolimus and Mycophenolate Mofetil in Preventing Acute Graft-Versus-Host Disease in Patients With Advanced Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplantation

NCT ID: NCT00096096

Last Updated: 2010-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31

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.

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.

Conditions

Chronic Myeloproliferative Disorders; Graft Versus Host Disease; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases

Study Design

• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

mycophenolate mofetil

Intervention Type: DRUG

tacrolimus

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Richard Nash, MD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

FHCRC-1893.00

Identifier Type: -

Identifier Source: secondary_id

CDR0000391026

Identifier Type: REGISTRY

Identifier Source: secondary_id

1893.00

Identifier Type: -

Identifier Source: org_study_id