NCT00003815

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy and radiation therapy plus bone marrow transplantation in treating patients who have aggressive non-Hodgkin's lymphoma.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 1994

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

September 17, 2013

Status Verified

July 1, 2001

First QC Date

November 1, 1999

Last Update Submit

September 16, 2013

Conditions

Lymphoma

Keywords

stage I adult diffuse mixed cell lymphomastage I adult diffuse large cell lymphomastage I adult immunoblastic large cell lymphomastage I adult lymphoblastic lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomacontiguous stage II adult diffuse mixed cell lymphomacontiguous stage II adult immunoblastic large cell lymphomacontiguous stage II adult diffuse large cell lymphomacontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult lymphoblastic lymphoma

Interventions

bleomycin sulfateBIOLOGICAL
carmustineDRUG
cyclophosphamideDRUG
cytarabineDRUG
doxorubicin hydrochlorideDRUG
etoposideDRUG
melphalanDRUG
prednisoloneDRUG
vincristine sulfateDRUG
autologous bone marrow transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed aggressive non-Hodgkin's lymphoma requiring chemotherapy * Stage II, III, or IV * B cell: * Centroblastic * Immunoblastic * Large cell anaplastic * Non-Burkitt lymphoblastic * T cell: * Pleomorphic medium cell * Pleomorphic large cell * Immunoblastic * Large cell anaplastic * Lymphoblastic * No Burkitt (L3) subtype * No large mediastinal mass OR * Stage I, II, III, or IV * Bulk disease greater than 10 cm * Nodal or extranodal site * No primary localized gut lymphoma * No CNS involvement PATIENT CHARACTERISTICS: Age: * 15 to 65 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * No concurrent bone marrow dysplastic syndromes Hepatic: * Bilirubin no greater than 2.5 times upper limit of normal (ULN) Renal: * Creatinine no greater than 2.5 times ULN Other: * No other malignancy except skin cancer or stage I cervical cancer * Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * Not specified 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)

Newcastle Upon Tyne Hospitals NHS Trust

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

Location

MeSH Terms

Conditions

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

Interventions

BleomycinCarmustineCyclophosphamideCytarabineDoxorubicinEtoposideMelphalanPrednisoloneVincristineRadiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsNitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesTherapeutics

Study Officials

  • Stephen J. Proctor, MD, FRCP, FRCPath

    Newcastle-upon-Tyne Hospitals NHS Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

June 1, 1994

Last Updated

September 17, 2013

Record last verified: 2001-07

Locations

GB(1)