NCT00096096

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

November 9, 2004

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Last Updated

May 13, 2010

Status Verified

May 1, 2010

Enrollment Period

1.7 years

First QC Date

November 9, 2004

Last Update Submit

May 12, 2010

Conditions

Chronic Myeloproliferative DisordersGraft Versus Host DiseaseLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Diseases

Keywords

graft versus host diseaseaccelerated phase chronic myelogenous leukemiarelapsing chronic myelogenous leukemiarecurrent adult Hodgkin lymphomarefractory multiple myelomarecurrent adult Burkitt lymphomachronic idiopathic myelofibrosisrecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent mantle cell lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult lymphoblastic lymphomasecondary acute myeloid leukemiasecondary myelodysplastic syndromesadult acute lymphoblastic leukemia in remissionde novo myelodysplastic syndromespreviously treated myelodysplastic syndromeschronic myelomonocytic leukemiarefractory anemia with excess blasts in transformationrefractory anemia with excess blastsrefractory anemia with ringed sideroblastsrefractory hairy cell leukemiajuvenile myelomonocytic leukemiachronic eosinophilic leukemiachronic neutrophilic leukemiachronic phase chronic myelogenous leukemiarecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarecurrent childhood acute lymphoblastic leukemiarecurrent childhood acute myeloid leukemiarecurrent childhood large cell lymphomarecurrent childhood lymphoblastic lymphomarecurrent childhood small noncleaved cell lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomarecurrent/refractory childhood Hodgkin lymphomarecurrent mycosis fungoides/Sezary syndromerefractory chronic lymphocytic leukemiarefractory cytopenia with multilineage dysplasiastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomaadult acute myeloid leukemia in remissionchildhood acute myeloid leukemia in remissionadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult 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 remissionchildhood chronic myelogenous leukemiablastic phase chronic myelogenous leukemiastage I multiple myelomastage II multiple myelomastage III multiple myelomamyelodysplastic/myeloproliferative disease, unclassifiablenodal marginal zone B-cell lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuesplenic marginal zone lymphomaatypical chronic myeloid leukemiastage III childhood large cell lymphomastage IV childhood large cell lymphomastage III childhood lymphoblastic lymphomastage IV childhood lymphoblastic lymphomastage III childhood small noncleaved cell lymphomastage IV childhood small noncleaved cell lymphomastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiastage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage III marginal zone lymphomastage IV marginal zone lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomachildhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

  • Efficacy

Secondary Outcomes (2)

  • Safety

  • Area under the curve of plasma mycophenolic acid

Interventions

mycophenolate mofetilDRUG
tacrolimusDRUG

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

Myeloproliferative DisordersGraft vs Host DiseaseLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesLeukemia, Myeloid, Accelerated PhaseHodgkin DiseaseBurkitt LymphomaPrimary MyelofibrosisLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticLymphoma, Mantle-CellLymphoma, FollicularPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myelomonocytic, ChronicAnemia, Refractory, with Excess of BlastsLeukemia, Hairy CellLeukemia, Myelomonocytic, JuvenilePdgfra-Associated Chronic Eosinophilic LeukemiaLeukemia, Neutrophilic, ChronicLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, AcuteDendritic Cell Sarcoma, InterdigitatingLymphoma, T-Cell, CutaneousLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellRecurrenceMycosis FungoidesSezary SyndromeCongenital AbnormalitiesBlast CrisisLeukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative

Interventions

Mycophenolic AcidTacrolimus

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, LymphoidAnemia, RefractoryAnemiaHistiocytic Disorders, MalignantHistiocytosisLymphoma, T-CellLeukemia, B-CellCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCell Transformation, NeoplasticCarcinogenesisNeoplastic Processes

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsMacrolidesLactones

Study Officials

  • Richard Nash, MD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2004

First Posted

November 9, 2004

Study Start

August 1, 2004

Primary Completion

May 1, 2006

Last Updated

May 13, 2010

Record last verified: 2010-05

Locations

US(1)