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

This study is currently recruiting patients.

Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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 Treatment or Intervention Phase
childhood Hodgkin's lymphoma
childhood non-Hodgkin's lymphoma
Graft Versus Host Disease
hematopoietic and lymphoid cancer
 Drug: mycophenolate mofetil
 Drug: tacrolimus
 Procedure: biological response modifier therapy
 Procedure: complications of therapy assessment/management
 Procedure: graft versus host disease prophylaxis/therapy
 Procedure: supportive care/therapy
Phase II

MedlinePlus related topics:  Hodgkin's Disease;   Immune System and Disorders;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-Versus-Host Disease in Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation

Further Study Details: 

OBJECTIVES: Primary

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.

Eligibility

Ages Eligible for Study:  up to  65 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

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

Location and Contact Information


Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109-1024,  United States; Recruiting
Richard Nash, MD  206-667-4978 

Study chairs or principal investigators

Richard Nash, MD,  Principal Investigator,  Fred Hutchinson Cancer Research Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000391026; FHCRC-1893.00; NCT00096096
Record last reviewed:  October 2004
Last Updated:  February 24, 2005
Record first received:  November 9, 2004
ClinicalTrials.gov Identifier:  NCT00096096
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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