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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00096096
Recruitment Status : Completed
First Posted : November 9, 2004
Last Update Posted : May 13, 2010
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

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
Chronic Myeloproliferative Disorders Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Drug: mycophenolate mofetil Drug: tacrolimus Phase 2

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Phase II Study of the Combination of Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-Versus-Host Disease
Study Start Date : August 2004
Actual Primary Completion Date : May 2006

Primary Outcome Measures :
  1. Efficacy

Secondary Outcome Measures :
  1. Safety
  2. Area under the curve of plasma mycophenolic acid

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 65 and under

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT ≤ 2.0 times ULN


  • Creatinine clearance ≥ 60 mL/min


  • 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


  • Not pregnant or nursing
  • Negative pregnancy test
  • No active systemic infection not controlled with antimicrobial therapy
  • HIV negative (HIV-1 or other virus)


Biologic therapy

  • No concurrent T-cell depleted hematopoietic stem cell graft


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00096096

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United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
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Principal Investigator: Richard Nash, MD Fred Hutchinson Cancer Research Center
Layout table for additonal information Identifier: NCT00096096    
Other Study ID Numbers: 1893.00
CDR0000391026 ( Registry Identifier: PDQ )
First Posted: November 9, 2004    Key Record Dates
Last Update Posted: May 13, 2010
Last Verified: May 2010
Keywords provided by Fred Hutchinson Cancer Research Center:
graft versus host disease
accelerated phase chronic myelogenous leukemia
relapsing chronic myelogenous leukemia
recurrent adult Hodgkin lymphoma
refractory multiple myeloma
recurrent adult Burkitt lymphoma
chronic idiopathic myelofibrosis
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent mantle cell lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult lymphoblastic lymphoma
secondary acute myeloid leukemia
secondary myelodysplastic syndromes
adult acute lymphoblastic leukemia in remission
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
chronic myelomonocytic leukemia
refractory anemia with excess blasts in transformation
refractory anemia with excess blasts
refractory anemia with ringed sideroblasts
refractory hairy cell leukemia
juvenile myelomonocytic leukemia
chronic eosinophilic leukemia
chronic neutrophilic leukemia
chronic phase chronic myelogenous leukemia
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Graft vs Host Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Mycophenolic Acid
Immunosuppressive Agents