NCT00255710

Brief Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor bone marrow or stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclophosphamide, mycophenolate mofetil, and tacrolimus after transplant may stop this from happening. PURPOSE: This phase I trial is studying cyclophosphamide and/or mycophenolate mofetil with or without tacrolimus to see which is the best regimen in treating patients who are undergoing a donor bone marrow or stem cell transplant for hematologic cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

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

July 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
Last Updated

March 17, 2010

Status Verified

March 1, 2010

First QC Date

November 18, 2005

Last Update Submit

March 16, 2010

Conditions

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

Keywords

graft versus host diseaseadult 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)adult acute lymphoblastic leukemia in remissionadult acute myeloid leukemia in remissionchronic idiopathic myelofibrosischronic myelomonocytic leukemiachronic phase chronic myelogenous leukemiamyelodysplastic/myeloproliferative disease, unclassifiablepreviously treated myelodysplastic syndromesrecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomastage II multiple myelomastage III adult Hodgkin lymphomastage III chronic lymphocytic leukemiastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III multiple myelomastage III small lymphocytic lymphomastage IV adult Hodgkin lymphomastage IV chronic lymphocytic leukemiastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV small lymphocytic lymphomastage II mycosis fungoides/Sezary syndromestage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromerefractory anemia with excess blasts in transformationrefractory anemia with excess blastsrefractory cytopenia with multilineage dysplasiaprimary systemic amyloidosisde novo myelodysplastic syndromessecondary acute myeloid leukemiasecondary myelodysplastic syndromesatypical chronic myeloid leukemia

Outcome Measures

Primary Outcomes (3)

  • Post-transplant immunosuppression regimen with ≤ 20% incidence of a grade II-IV graft-versus-host-disease (GVHD) and < 10% incidence of nonengraftment (< 5% donor chimerism) at day 60 following transplant

  • Incidence and severity of acute GVHD at day 60 following transplant

  • Frequency of mixed chimerism defined as any detectable donor cells at day 60 following transplant

Interventions

allogeneic bone marrow transplantationPROCEDURE
filgrastimBIOLOGICAL
cyclophosphamideDRUG
fludarabine phosphateDRUG
mycophenolate mofetilDRUG
tacrolimusDRUG
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following hematologic malignancies: * Stage II or III multiple myeloma * Amyloidosis * Myelofibrosis with ≥ 2 of the following high-risk features: * Over 55 years of age * Hemoglobin \< 10 g/dL * WBC \< 3,000/mm\^3 OR \> 10,000/mm\^3 * Platelet count \< 100,000/mm\^3 * Cytogenetic abnormalities * Mycosis fungoides, meeting 1 of the following criteria: * Stage IIB or III disease with evidence of histologic conversion to an aggressive lymphoma * Must demonstrate chemosensitivity * Stage IV disease * Paroxysmal nocturnal hemoglobinuria * Not meeting criteria for other bone marrow transplantation (BMT) or treatment studies * Diagnosis of 1 of the following hematologic malignancies, for which patient is not eligible for potentially curative allogeneic BMT due to end-organ dysfunction, age 65 to 75, or the amount of prior chemotherapy: * Acute myeloid or acute lymphoblastic leukemia * High-risk disease in first or second (or further) complete remission * Relapsed aggressive non-Hodgkin's lymphoma * Not eligible for autologous or standard allogeneic BMT * Hodgkin's lymphoma in second or further complete or partial remission * Not eligible for autologous or standard allogeneic BMT * Myelodysplastic syndromes or myelodysplastic/myeloproliferative diseases * Any of the following subtypes: * Refractory anemia with excess blasts (RAEB) * RAEB in transformation * Chronic myelomonocytic leukemia * Any morphologic subtype with multiple chromosomal abnormalities * Any subset with life-threatening cytopenias in all 3 cell lines, defined as platelet count ≤ 20,000/mm\^3, absolute neutrophil count ≤ 500/mm\^3, and reticulocyte count ≤ 50,000/mm\^3 * Meets both of the following criteria: * Less than 20% blasts by bone marrow biopsy * Not eligible for standard allogeneic BMT * No refractory anemia with ringed sideroblasts * No 5q syndrome * Stage III or IV chronic lymphocytic leukemia * Not meeting criteria for other BMT studies * Chronic myelogenous leukemia in first or second chronic phase * Not meeting criteria for other BMT studies or treatment * Stage III or IV indolent small lymphocytic or follicular lymphoma * Not eligible for autologous or standard allogeneic BMT or other active protocols at Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins * Must have an HLA-identical related donor available PATIENT CHARACTERISTICS: Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * Bilirubin ≤ 3.0 mg/dL * AST ≤ 175 U/L * ALT ≤ 200 U/L Renal * Creatinine ≤ 3.0 mg/dL Cardiovascular * LVEF ≥ 30% Pulmonary * FEV\_1 ≥ 40% predicted * Forced vital capacity ≥ 40% predicted Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative PRIOR CONCURRENT THERAPY: Chemotherapy * See Disease Characteristics

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

MeSH Terms

Conditions

Myeloproliferative DisordersGraft vs Host DiseaseLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesCongenital AbnormalitiesPrimary MyelofibrosisLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, Chronic-PhaseBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellHodgkin DiseaseLeukemia, Lymphocytic, Chronic, B-CellMycosis FungoidesSezary SyndromeAnemia, Refractory, with Excess of BlastsImmunoglobulin Light-chain AmyloidosisLeukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative

Interventions

FilgrastimCyclophosphamidefludarabine phosphateMycophenolic AcidTacrolimusPeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, Myelogenous, Chronic, BCR-ABL PositiveEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, LymphoidLeukemia, B-CellLymphoma, T-Cell, CutaneousLymphoma, T-CellAnemia, RefractoryAnemiaAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

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 AcidsLipidsMacrolidesLactonesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Carol A. Huff, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 18, 2005

First Posted

November 21, 2005

Study Start

July 1, 2002

Last Updated

March 17, 2010

Record last verified: 2010-03

Locations

US(1)