NCT00003152

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and radiation therapy and kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy followed by interferon alfa alone or combination chemotherapy plus radiation therapy and peripheral stem cell transplantation in treating patients who have previously untreated stage III or stage IV follicular non-Hodgkin's lymphoma.

Trial Health

40
At Risk

Trial Health Score

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

Enrollment
469

participants targeted

Target at P50-P75 for phase_3 lymphoma

Geographic Reach
2 countries

2 active sites

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

March 1, 1997

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 1999

Completed
4.8 years until next milestone

First Posted

Study publicly available on registry

August 2, 2004

Completed
Last Updated

July 2, 2012

Status Verified

June 1, 2012

Enrollment Period

2.7 years

First QC Date

November 1, 1999

Last Update Submit

June 29, 2012

Conditions

Lymphoma

Keywords

stage 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 lymphoma

Interventions

filgrastimBIOLOGICAL
recombinant interferon alfaBIOLOGICAL
cyclophosphamideDRUG
prednisoneDRUG
vincristine sulfateDRUG
autologous bone marrow transplantationPROCEDURE
bone marrow ablation with stem cell supportPROCEDURE
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Previously untreated follicular stage III or IV non-Hodgkin's lymphoma At least one measurable mass PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Alkaline phosphatase and bilirubin less than 2.5 times upper limit of normal (ULN) (unless clearly related to NHL) Renal: Creatinine and BUN less than 2.5 times ULN (unless clearly related to NHL) Cardiovascular: No severe cardiac disease (e.g. severe heart failure requiring treatment or cardiac ejection fraction less than 45%) Neurologic: No neurologic disease Pulmonary: No pulmonary disease Other: Not pregnant No prior malignancies except nonmelanoma skin cancer or carcinoma in situ of the cervix Not HIV positive No psychiatric or metabolic disease PRIOR CONCURRENT THERAPY: See Disease Characteristics No concurrent immunotherapeutic drugs, chemotherapy, or radiotherapy

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

Sponsors & Collaborators

Study Sites (2)

Academisch Ziekenhuis Utrecht

Utrecht, 3508 GA, Netherlands

Location

Addenbrooke's NHS Trust

Cambridge, England, CB2 2QQ, United Kingdom

Location

MeSH Terms

Conditions

LymphomaLymphoma, Follicular

Interventions

FilgrastimInterferon-alphaCyclophosphamidePrednisoneVincristinePeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsInterferon Type IInterferonsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Anton Hagenbeek, MD, PhD

    UMC Utrecht

    STUDY CHAIR

  • Robert Marcus, MD

    Cambridge University Hospitals NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 2, 2004

Study Start

March 1, 1997

Primary Completion

November 1, 1999

Last Updated

July 2, 2012

Record last verified: 2012-06

Locations

NL(1)GB(1)