NCT00003639

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 and slow the growth of non-Hodgkin's lymphoma. It is not yet known whether combining more than one chemotherapy drug with interferon alfa is more effective than chemotherapy alone in treating patients with low-grade non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without interferon alfa in treating patients with low-grade non-Hodgkin's lymphoma.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3 lymphoma

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

November 1, 1993

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.7 years until next milestone

First Posted

Study publicly available on registry

July 16, 2004

Completed
Last Updated

September 17, 2013

Status Verified

May 1, 2007

First QC Date

November 1, 1999

Last Update Submit

September 16, 2013

Conditions

Lymphoma

Keywords

stage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomacontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

recombinant interferon alfaBIOLOGICAL
chlorambucilDRUG
dexamethasoneDRUG
idarubicinDRUG

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed B cell low grade non-Hodgkin's lymphoma Stage II, III or IV Measurable disease No chronic lymphatic leukemia, prolymphocytic leukemia and hairy cell leukemia, angioimmunoblastic lymphadenopathy, mycosis fungoides, Sezary's syndrome and T-zone lymphoma, plasmacytoma, T cell lymphomas, or centroblastic lymphoma No CNS disease A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 15 to 70 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 2,000/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.96 mg/dL AST/ALT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.65 mg/dL OR Creatinine clearance no greater than 40 mL/min Cardiovascular: No history of myocardial infarction in the past 12 months No severe or uncontrolled cardiac failure Other: No history of malignant disease except basal cell carcinoma or carcinoma in situ of the cervix No active peptic ulceration, significant dyspepsia, or history of hematemesis or melena No concurrent medical or psychological condition that may preclude study participation Not pregnant Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior extensive radiotherapy for any malignant disease Prior radiotherapy for localized disease that subsequently relapses permitted 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)

Royal Victoria Infirmary

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

Location

MeSH Terms

Conditions

LymphomaLymphoma, FollicularLeukemia, Lymphocytic, Chronic, B-CellLymphoma, B-Cell, Marginal Zone

Interventions

Interferon-alphaChlorambucilDexamethasoneIdarubicin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-HodgkinLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicAminoglycosidesGlycosidesCarbohydrates

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

July 16, 2004

Study Start

November 1, 1993

Last Updated

September 17, 2013

Record last verified: 2007-05

Locations

GB(1)