NCT00005852

Brief Summary

RATIONALE: Bone marrow from donors may be able to treat patients with severe aplastic anemia and patients whose bodies have rejected previous bone marrow transplantation. PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating patients who have severe aplastic anemia or whose bodies have rejected previous bone marrow transplant.

Trial Health

55
Monitor

Trial Health Score

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

Timeline
Completed

Started Jun 1996

Longer than P75 for phase_2

Status
terminated

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

June 1, 1996

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed
4.2 years until next milestone

First Posted

Study publicly available on registry

July 26, 2004

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

December 11, 2012

Status Verified

December 1, 2012

Enrollment Period

11.1 years

First QC Date

June 2, 2000

Last Update Submit

December 10, 2012

Conditions

Chronic Myeloproliferative DisordersGraft Versus Host DiseaseLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic Syndromes

Keywords

recurrent childhood acute lymphoblastic leukemiarecurrent adult Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarefractory multiple myelomastage I multiple myelomastage II multiple myelomastage III multiple myelomarecurrent childhood lymphoblastic lymphomarecurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarelapsing chronic myelogenous leukemiarefractory chronic lymphocytic leukemiaprimary myelofibrosischildhood acute promyelocytic leukemia (M3)refractory hairy cell leukemiarecurrent/refractory childhood Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomapreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesgraft versus host diseaserecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomachildhood myelodysplastic syndromes

Interventions

anti-thymocyte globulinBIOLOGICAL
filgrastimBIOLOGICAL
muromonab-CD3BIOLOGICAL
cyclophosphamideDRUG
cyclosporineDRUG
methylprednisoloneDRUG
allogeneic bone marrow transplantationPROCEDURE

Eligibility Criteria

Age15 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: Histologically confirmed aplastic anemia Must have related donor with a genotypic 6 out of 6 HLA A, B, and DR match OR Bone marrow transplant failure Must have related donor with at least a 5 out of 6 HLA match OR Must have an unrelated donor with at least a 5 out of 6 HLA match PATIENT CHARACTERISTICS: Age: 15 to 55 Performance status: Aplastic anemia patients: Karnofsky 80-100% Graft failure patients: Karnofsky 20-100% Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Aplastic anemia patients: Bilirubin no greater than 2.0 mg/dL SGOT/SGPT no greater than 3 times normal PT/PTT normal (except when aplastic anemia secondary to viral hepatitis) Graft failure patients: Mild to severe venoocclusive disease allowed Renal: Aplastic anemia patients: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: Aplastic anemia patients: Left ventricular ejection fraction at least 45% by MUGA or echocardiography No myocardial infarction within the past 6 months No uncontrolled arrhythmias Pulmonary: Aplastic anemia patients: FEV1 and DLCO at least 50% predicted Other: Aplastic anemia patients: No uncontrolled diabetes mellitus or thyroid disease No active serious infections HIV negative Not pregnant or nursing Negative pregnancy test No psychosocial problem that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics 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

MeSH Terms

Conditions

Myeloproliferative DisordersGraft vs Host DiseaseLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesPrecursor Cell Lymphoblastic Leukemia-LymphomaHodgkin DiseaseLymphoma, T-Cell, CutaneousLeukemia, Myeloid, AcuteLeukemia, Lymphocytic, Chronic, B-CellPrimary MyelofibrosisLeukemia, Hairy CellRecurrenceLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaDendritic Cell Sarcoma, InterdigitatingLymphoma, Mantle-CellLymphoma, B-Cell, Marginal Zone

Interventions

Antilymphocyte SerumFilgrastimMuromonab-CD3CyclophosphamideCyclosporineMethylprednisolone

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLeukemia, LymphoidLymphoma, T-CellLeukemia, MyeloidLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsHistiocytic Disorders, MalignantHistiocytosis

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex MixturesGranulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesBiological FactorsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalImmunoglobulin GImmunoglobulin IsotypesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring Compounds

Study Officials

  • Steven C. Goldstein, MD

    H. Lee Moffitt Cancer Center and Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2000

First Posted

July 26, 2004

Study Start

June 1, 1996

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

December 11, 2012

Record last verified: 2012-12