NCT00005787

Brief Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Treating the peripheral stem cells in the laboratory may improve the effectiveness of the transplant. PURPOSE: Phase I trial to study the effectiveness of peripheral stem cell transplantation in patients who have relapsed or refractory non-Hodgkin's lymphoma and who will be treated with high-dose chemotherapy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_1 lymphoma

Timeline
Completed

Started Sep 1999

Shorter than P25 for phase_1 lymphoma

Geographic Reach
1 country

1 active site

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

September 1, 1999

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2002

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

June 1, 2012

Status Verified

May 1, 2012

Enrollment Period

2.3 years

First QC Date

June 2, 2000

Last Update Submit

May 31, 2012

Conditions

LymphomaNeutropenia

Keywords

neutropeniarecurrent 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 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 lymphoma

Interventions

epoetin alfaBIOLOGICAL
filgrastimBIOLOGICAL
recombinant flt3 ligandBIOLOGICAL
recombinant interleukin-3BIOLOGICAL
sargramostimBIOLOGICAL
in vitro-treated peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age17 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven relapsed or refractory non-Hodgkin's lymphoma * Scheduled to undergo high-dose chemotherapy (carmustine, etoposide, cytarabine, and melphalan) with autologous peripheral blood mononuclear cell transplantation * No metastatic disease involving the bone marrow PATIENT CHARACTERISTICS: Age: * 17 to 65 Performance status: * ECOG 0 or 1 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * No active hepatitis B or C * Bilirubin less than 2.5 times normal\* * SGOT or SGPT less than 2.5 times normal\* * Alkaline phosphatase less than 2.5 times normal NOTE: \* Unless Gilbert's syndrome present Renal: * Creatinine clearance greater than 50 mL/min Cardiovascular: * Cardiac ejection fraction normal Pulmonary: * DLCO at least 50% predicted * FEV\_1 and FVC at least 75% predicted Other: * HIV negative * Not pregnant * Negative pregnancy test * No non-neoplastic disease that would preclude intensive chemotherapy PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * No prior external beam radiotherapy to more than 25% of the active bone marrow 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)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

MeSH Terms

Conditions

LymphomaNeutropeniaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

Epoetin AlfaFilgrastimflt3 ligand proteinStem Cell Factorsargramostim

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesLeukocyte DisordersLymphoma, B-CellLeukemia, LymphoidLeukemiaEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsGranulocyte Colony-Stimulating Factor

Study Officials

  • Jane N. Winter, MD

    Robert H. Lurie Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2000

First Posted

January 27, 2003

Study Start

September 1, 1999

Primary Completion

January 1, 2002

Study Completion

January 1, 2002

Last Updated

June 1, 2012

Record last verified: 2012-05

Locations

US(1)