NCT00028665

Brief Summary

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known if combining rituximab with cyclophosphamide is more effective than cyclophosphamide alone in stimulating peripheral stem cells for transplantation. PURPOSE: This randomized phase II trial is studying how well giving cyclophosphamide with or without rituximab followed by chemotherapy and peripheral stem cell transplantation works in treating patients with recurrent non-Hodgkin's lymphoma.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for phase_2 lymphoma

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, 2000

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2002

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Last Updated

June 10, 2010

Status Verified

June 1, 2010

Enrollment Period

4.8 years

First QC Date

January 4, 2002

Last Update Submit

June 9, 2010

Conditions

Lymphoma

Keywords

stage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic 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 lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphoma

Outcome Measures

Primary Outcomes (4)

  • Total CD34 cells

    measured at baseline, at time of harvests, days 42 and 90 after the transplant, and 6 and 12 months after the transplant

  • T and B lymphocyte counts

    measured at baseline, at time of harvests, days 42 and 90 after the transplant, and 6 and 12 months after the transplant

  • Disease response

    measured at 4 weeks after the transplant

  • Engraftment

    measured at days 42 and 90 after the transplant, and 6 and 12 months after the transplant

Study Arms (2)

Arm I: with rituximab IV

EXPERIMENTAL
Biological: filgrastimBiological: rituximabDrug: carmustineDrug: cisplatinDrug: cyclophosphamideDrug: etoposideProcedure: bone marrow ablation with stem cell supportProcedure: peripheral blood stem cell transplantationRadiation: radiation therapy

Arm II: without rituximab IV

ACTIVE COMPARATOR
Biological: filgrastimDrug: carmustineDrug: cisplatinDrug: cyclophosphamideDrug: etoposideProcedure: bone marrow ablation with stem cell supportProcedure: peripheral blood stem cell transplantationRadiation: radiation therapy

Interventions

filgrastimBIOLOGICAL

Beginning 36-48 hours after the completion of cyclophosphamide, patients receive filgrastim (G-CSF) subcutaneously (SC) daily until blood counts recover. Patients receive G-CSF SC daily beginning 4 hours after completion of PBSC infusion and continuing until neutrophil engraftment.

Arm I: with rituximab IVArm II: without rituximab IV
rituximabBIOLOGICAL

rituximab IV over 2-5 hours on days 1, 8, and 15

Arm I: with rituximab IV
carmustineDRUG

After completion of PBSC collection, patients receive high-dose chemotherapy comprising carmustine IV on days -7 to -3

Arm I: with rituximab IVArm II: without rituximab IV
cisplatinDRUG

After completion of PBSC collection, cisplatin IV for 3 days during days -7 to -3.

Arm I: with rituximab IVArm II: without rituximab IV
cyclophosphamideDRUG

cyclophosphamide IV over 3-6 hours on day 16.

Arm I: with rituximab IVArm II: without rituximab IV
etoposideDRUG

After completion of PBSC collection, etoposide IV for 3 days during days -7 to -3.

Arm I: with rituximab IVArm II: without rituximab IV
bone marrow ablation with stem cell supportPROCEDURE

Patients then undergo peripheral blood stem cell (PBSC) collection.

Arm I: with rituximab IVArm II: without rituximab IV
peripheral blood stem cell transplantationPROCEDURE

Arm I: Patients receive unmanipulated PBSCs on day 0. Arm II: Patients receive CD34 cell-enriched PBSC on day 0.

Arm I: with rituximab IVArm II: without rituximab IV
radiation therapyRADIATION

Patients may undergo involved-field radiotherapy to active or previously bulky (more than 5 cm) tumors daily for 7-10 days.

Arm I: with rituximab IVArm II: without rituximab IV

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed B-cell non-Hodgkin's lymphoma (NHL) * Indolent or aggressive histology * No small lymphocytic lymphoma, Burkitt's lymphoma, or small lymphocytic non-Burkitt's lymphoma * CD20-positive and/or CD19-positive by immunohistochemistry or flow cytometry * Second or greater remission allowed * Partial remission, relapse, or refractory disease must have measurable tumor * Eligible for high-dose therapy followed by autologous peripheral blood stem cell transplantation * No CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age: * 12 to 65 Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1,200/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL Renal: * Creatinine clearance at least 60 mL/min * No renal dysfunction Cardiovascular: * LVEF at least 40% * No cardiac dysfunction * No myocardial infarction within the past 3 months Pulmonary: * FEV\_1 greater than 60% * DLCO at least 60% of predicted * No pulmonary dysfunction * No asthma Other: * HIV negative * No significant organ dysfunction * No severe comorbid condition * No uncontrolled diabetes * No severe or active infection * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Chemotherapy * No prior immunotherapy Chemotherapy: * No prior high-dose chemotherapy with or without peripheral blood stem cell transplantation * No more than 3 prior chemotherapy regimens for NHL * At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: * Not specified Radiotherapy: * Prior radiotherapy allowed 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)

Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

Cleveland, Ohio, 44106-7284, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, Mantle-Cell

Interventions

FilgrastimRituximabCarmustineCisplatinCyclophosphamideEtoposidePeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsSerum GlobulinsGlobulinsNitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Omer N. Koc, MD

    Case Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2002

First Posted

January 27, 2003

Study Start

June 1, 2000

Primary Completion

March 1, 2005

Last Updated

June 10, 2010

Record last verified: 2010-06

Locations

US(1)