NCT00274794

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as busulfan, etoposide, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving colony-stimulating factors, such as G-CSF, monoclonal antibodies, such as rituximab, or chemotherapy, such as etoposide, helps stem cells move from the bone marrow to the blood so they can be collected and stored until transplant. Giving etoposide and G-CSF together with rituximab before a peripheral stem cell transplant may be an effective treatment for non-Hodgkin's lymphoma. PURPOSE: This randomized clinical trial is studying how well giving etoposide and G-CSF with or without rituximab works in treating patients who are undergoing an autologous peripheral stem cell transplant for B-cell non-Hodgkin's lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable lymphoma

Timeline
Completed

Started Feb 2000

Longer than P75 for not_applicable 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

February 1, 2000

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

March 29, 2011

Status Verified

March 1, 2011

Enrollment Period

6.2 years

First QC Date

January 10, 2006

Last Update Submit

March 28, 2011

Conditions

Lymphoma

Keywords

noncontiguous stage II adult Burkitt lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell 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 lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell 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 lymphomanoncontiguous stage II adult immunoblastic large cell lymphomarecurrent adult immunoblastic large cell lymphomastage III adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomarecurrent adult lymphoblastic lymphomastage III adult lymphoblastic lymphomastage IV adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular 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 lymphomanoncontiguous stage II mantle cell lymphomarecurrent mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomanoncontiguous stage II marginal zone lymphomarecurrent marginal zone lymphomasplenic marginal zone lymphomastage III marginal zone lymphomastage IV marginal zone lymphomanoncontiguous stage II small lymphocytic lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphoma

Outcome Measures

Primary Outcomes (2)

  • Correlate CD34+ cell yields with the addition of rituximab

    At least two weeks prior to transplant

  • Acute toxicity of rituximab, etoposide, and filgrastim (G-CSF)

    100 days post transplant

Study Arms (2)

Rituxan + Etoposide + G-CSF

OTHER
Biological: filgrastimBiological: rituximab

Etoposide + G-CSF

OTHER
Biological: filgrastim

Interventions

filgrastimBIOLOGICAL

10mcg/kg/d subcutaneously, beginning 48 hours after completion of Etoposide

Etoposide + G-CSFRituxan + Etoposide + G-CSF
rituximabBIOLOGICAL

375 mg/m2, IV, Once per week for 3 weeks.

Rituxan + Etoposide + G-CSF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Patients with B-cell malignancies who are appropriate candidates for high-dose chemotherapy and autologous stem cell transplantation and meet 1 of the following criteria: * Relapsed or refractory B-cell non-Hodgkin's Lymphoma (NHL) * Patients with B-cell NHL in first remission and who have significant risk for later relapse * Patients with other B-cell malignancies otherwise eligible for autologous stem cell transplantation PATIENT CHARACTERISTICS: * Life expectancy at least 2 months * Cardiac ejection fraction ≥ 45% * DLCO ≥ 45% * Creatinine \< 2.0 mg/dL * Bilirubin \< 2.0 mg/dL * AST \< 2 times normal * Platelet count ≥ 50,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Absolute lymphocyte count ≤ 10,000/mm\^3 * HIV negative * No severe medical or psychiatric illnesses * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * More than 8 weeks since prior rituximab

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

  • Copelan E, Pohlman B, Rybicki L, Kalaycio M, Sobecks R, Andresen S, Dean R, Koo A, Chan J, Sweetenham J, Bolwell B. A randomized trial of etoposide and G-CSF with or without rituximab for PBSC mobilization in B-cell non-Hodgkin's lymphoma. Bone Marrow Transplant. 2009 Jan;43(2):101-5. doi: 10.1038/bmt.2008.306. Epub 2008 Sep 15.

    PMID: 18794865RESULT

MeSH Terms

Conditions

LymphomaLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

FilgrastimRituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, LymphoidLeukemiaHematologic DiseasesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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 GlobulinsGlobulins

Study Officials

  • Brian J. Bolwell, MD

    Cleveland Clinic Taussig Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 11, 2006

Study Start

February 1, 2000

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

March 29, 2011

Record last verified: 2011-03

Locations

US(1)