NCT00006042

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells. PURPOSE: Phase I trial to study the effectiveness of cyclophosphamide plus bone marrow transplantation in treating patients who have 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

December 1, 1999

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

March 10, 2010

Status Verified

March 1, 2010

First QC Date

July 5, 2000

Last Update Submit

March 9, 2010

Conditions

LeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Diseases

Keywords

recurrent adult Hodgkin lymphomaBurkitt lymphomarefractory multiple myelomastage II multiple myelomastage III multiple myelomarecurrent childhood lymphoblastic lymphomastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarelapsing chronic myelogenous leukemiarefractory chronic lymphocytic leukemiachronic phase chronic myelogenous leukemiaadult acute myeloid leukemia in remissionadult acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemia in remissionchildhood acute lymphoblastic leukemia in remissionrecurrent/refractory childhood Hodgkin lymphomastage II adult lymphoblastic lymphomastage III grade 3 follicular lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult Burkitt lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt 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 lymphomade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesrecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult lymphoblastic lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomachildhood chronic myelogenous leukemiaatypical chronic myeloid leukemiamyelodysplastic/myeloproliferative disease, unclassifiablerecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomaadult acute myeloid leukemia with t(8;21)(q22;q22)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with t(15;17)(q22;q12)childhood myelodysplastic syndromes

Interventions

filgrastimBIOLOGICAL
cyclophosphamideDRUG
fludarabine phosphateDRUG
mycophenolate mofetilDRUG
tacrolimusDRUG
allogeneic bone marrow transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Patients with any of the following diagnoses: * Chronic myelogenous leukemia * Chronic phase 1 * Failed prior interferon alfa therapy OR * Relapsed after prior autologous stem cell transplantation * Chronic phase 2 * Acute leukemia * Standard risk * Age over 60 years * Complete remission 1 (CR1) * High risk * High WBC at presentation, unfavorable cytogenetics, mixed lineage, delayed response to induction chemotherapy * CR1 * Complete remission 2 or higher * Acute lymphocytic leukemia * CR1 or higher * Myelodysplastic syndrome * Untreated OR * CR1 * Acute myeloid leukemia in CR1 * Chronic lymphocytic leukemia * Rai stage III or IV OR * Received prior autologous stem cell transplantation * Multiple myeloma * Stage II or III * Stable or progressive disease after prior chemotherapy OR * Received prior autologous stem cell transplantation * Non-Hodgkin's Lymphoma * Hodgkin's lymphoma * Ineligible for or refused autologous or standard allogeneic bone marrow transplantation * Ineligible for bone marrow transplantation from an HLA matched, sibling donor or from an HLA matched, unrelated donor * Must have an HLA mismatched, related donor (3-5 out of 6) PATIENT CHARACTERISTICS: Age: * 0.5 to 70 Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin less than 3.1 mg/dL Renal: * Not specified Cardiovascular: * Left ventricular ejection fraction at least 35% Pulmonary: * FEV\_1 and FVC at least 40% of predicted OR * FEV\_1 and FVC at least 60% in patients who have received prior thoracic or mantle radiotherapy Other: * HIV negative * No other debilitating medical or psychiatric illness that would preclude study compliance * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No prior transfusions from donor Chemotherapy: * See Disease Characteristics 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)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Related Publications (1)

  • O'Donnell PV, Luznik L, Jones RJ, Vogelsang GB, Leffell MS, Phelps M, Rhubart P, Cowan K, Piantados S, Fuchs EJ. Nonmyeloablative bone marrow transplantation from partially HLA-mismatched related donors using posttransplantation cyclophosphamide. Biol Blood Marrow Transplant. 2002;8(7):377-86. doi: 10.1053/bbmt.2002.v8.pm12171484.

    PMID: 12171484RESULT

MeSH Terms

Conditions

LeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesHodgkin DiseaseBurkitt LymphomaLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, Chronic-PhaseRecurrencePrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticDendritic Cell Sarcoma, InterdigitatingLymphoma, Mantle-CellLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative DisordersLymphoma, B-Cell, Marginal ZoneCongenital Abnormalities

Interventions

FilgrastimCyclophosphamidefludarabine phosphateMycophenolic AcidTacrolimusRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBone Marrow DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidHistiocytic Disorders, MalignantHistiocytosisCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsMacrolidesLactonesTherapeutics

Study Officials

  • Ephraim J. Fuchs, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2000

First Posted

January 27, 2003

Study Start

December 1, 1999

Last Updated

March 10, 2010

Record last verified: 2010-03

Locations

US(1)