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

Lymphoma Clinical Trial

Official title:

A Phase II Study of the Combination of Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-Versus-Host Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00096096
• Other study ID #: 1893.00
• Secondary ID: FHCRC-1893.00CDR
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2004
• Last updated: May 12, 2010
• Start date: August 2004

Study information

• Verified date: May 2010
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 65 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Myeloproliferative Disorders
• Graft Versus Host Disease
• Graft vs Host Disease
• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Diseases
• Myeloproliferative Disorders
• Neoplasms, Plasma Cell
• Plasmacytoma
• Preleukemia

Intervention

Drug:
• mycophenolate mofetil

• tacrolimus

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy
Secondary	Safety
Secondary	Area under the curve of plasma mycophenolic acid