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


Phase 2
N/A
65 Years
Not Enrolling
Both
Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Efficacy

Principal Investigator

Richard Nash, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1893.00

NCT ID:

NCT00096096

Start Date:

August 2004

Completion Date:

Related Keywords:

  • Chronic Myeloproliferative Disorders
  • Graft Versus Host Disease
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • 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
  • recurrent adult acute lymphoblastic leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • recurrent childhood large cell lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • refractory chronic lymphocytic leukemia
  • refractory cytopenia with multilineage dysplasia
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • adult acute myeloid leukemia in remission
  • childhood acute myeloid leukemia in remission
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • childhood acute lymphoblastic leukemia in remission
  • childhood chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • myelodysplastic/myeloproliferative disease, unclassifiable
  • nodal marginal zone B-cell lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • splenic marginal zone lymphoma
  • atypical chronic myeloid leukemia
  • stage III childhood large cell lymphoma
  • stage IV childhood large cell lymphoma
  • stage III childhood lymphoblastic lymphoma
  • stage IV childhood lymphoblastic lymphoma
  • stage III childhood small noncleaved cell lymphoma
  • stage IV childhood small noncleaved cell lymphoma
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • stage III adult Burkitt lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage IV adult Burkitt lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage III marginal zone lymphoma
  • stage IV marginal zone lymphoma
  • stage III small lymphocytic lymphoma
  • stage IV small lymphocytic lymphoma
  • childhood myelodysplastic syndromes
  • Neoplasms
  • Graft vs Host Disease
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Lymphoma, Large-Cell, Immunoblastic
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109