NCT00089037

Brief Summary

RATIONALE: Sirolimus, tacrolimus, and methotrexate may be effective in preventing acute graft-versus-host disease in patients who are undergoing donor stem cell transplantation. PURPOSE: This phase I/II trial is studying the side effects of sirolimus when given together with tacrolimus and methotrexate and to see how well they work in preventing acute graft-versus-host disease in patients who are undergoing donor stem cell transplantation for hematologic cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 2003

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2004

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
Last Updated

July 15, 2011

Status Verified

July 1, 2011

Enrollment Period

1.8 years

First QC Date

August 4, 2004

Last Update Submit

July 13, 2011

Conditions

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

Keywords

graft versus host diseaseaccelerated phase chronic myelogenous leukemiaatypical chronic myeloid leukemiablastic phase chronic myelogenous leukemiachronic eosinophilic leukemiachronic idiopathic myelofibrosischronic myelomonocytic leukemiachronic neutrophilic leukemiamyelodysplastic/myeloproliferative disease, unclassifiablepreviously treated myelodysplastic syndromesrecurrent adult acute lymphoblastic leukemiaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomade novo myelodysplastic syndromesadult acute lymphoblastic leukemia in remissionadult acute myeloid leukemia in remissionchildhood acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemia in remissionrecurrent adult acute myeloid leukemiarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Hodgkin lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent mycosis fungoides/Sezary syndromerecurrent small lymphocytic lymphomarefractory chronic lymphocytic leukemiarefractory hairy cell leukemiarefractory multiple myelomarelapsing chronic myelogenous leukemiasecondary acute myeloid leukemiasecondary myelodysplastic syndromesnoncontiguous stage II adult Burkitt lymphomastage III adult Burkitt lymphomastage IV adult Burkitt lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II marginal zone lymphomanoncontiguous stage II small lymphocytic lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage III adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage III mantle cell lymphomastage IV mantle cell lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomastage III marginal zone lymphomastage IV marginal zone lymphomachildhood chronic myelogenous leukemiarecurrent childhood acute lymphoblastic leukemiarecurrent childhood acute myeloid leukemiarecurrent childhood large cell lymphomarecurrent childhood lymphoblastic lymphomarecurrent childhood small noncleaved cell lymphomauntreated childhood acute lymphoblastic leukemiauntreated childhood acute myeloid leukemia and other myeloid malignanciesrecurrent/refractory childhood Hodgkin lymphomajuvenile myelomonocytic leukemiasplenic marginal zone lymphomauntreated adult acute lymphoblastic leukemiauntreated adult acute myeloid leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiastage I multiple myelomastage II multiple myelomastage III multiple myelomarefractory cytopenia with multilineage dysplasiarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent marginal zone lymphoma

Interventions

methotrexateDRUG
sirolimusDRUG
tacrolimusDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of hematological malignancy * No chronic phase chronic myelogenous leukemia, de novo acute leukemia in first remission, or myelodysplastic syndromes with refractory anemia * Scheduled for hematopoietic stem cell transplantation from unrelated donors * Currently receiving conditioning regimen comprising cyclosporine and total body radiotherapy (1,200 to 1,350 cGy) or busulfan and cyclosporine * Donor must be typed to the highest level of resolution * One single non-serologic disparity for A, B, or C alleles allowed provided the disparity is within the third or fourth digit of the allele * No mismatch at DRB1 or DQB1 PATIENT CHARACTERISTICS: Age * Per primary treatment protocol Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * SGOT and SGPT ≤ 2.0 times upper limit of normal * Bilirubin normal * Hepatitis B and C virus negative Renal * Creatinine clearance ≥ 70 mL/min Cardiovascular * No cardiac insufficiency requiring treatment * No coronary artery disease Pulmonary * No acute pulmonary infection by chest x-ray * No severe hypoxemia with pO\_2 \< 70 mm Hg AND DLCO \< 70% of predicted * No mild hypoxemia with pO\_2 \< 80 mm Hg AND DLCO \< 60% of predicted Other * Not pregnant or nursing * Negative pregnancy test * HIV negative * No active systemic infection * No known hypersensitivity to macrolide antibiotics (e.g., erythromycin, azithromycin, or clarithromycin) * No prior intolerance or unresponsiveness to sirolimus PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No concurrent T-cell depleted transplantations Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics Surgery * Not specified Other * No concurrent grapefruit juice * No concurrent voriconazole

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 PhaseLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBlast CrisisPdgfra-Associated Chronic Eosinophilic LeukemiaPrimary MyelofibrosisLeukemia, Myelomonocytic, ChronicLeukemia, Neutrophilic, ChronicPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, B-Cell, Marginal ZoneLeukemia, Myeloid, AcuteBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellDendritic Cell Sarcoma, InterdigitatingRecurrenceLeukemia, Myelomonocytic, JuvenileLymphoma, T-Cell, Cutaneous

Interventions

MethotrexateSirolimusTacrolimus

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 SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLeukemia, LymphoidLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, T-CellLeukemia, B-CellHistiocytic Disorders, MalignantHistiocytosis

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMacrolidesLactonesOrganic Chemicals

Study Officials

  • Hans-Peter Kiem, MD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2004

First Posted

August 5, 2004

Study Start

June 1, 2003

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

July 15, 2011

Record last verified: 2011-07

Locations

US(1)