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NCT00003578

High Dose Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Intermediate- or High-Grade Non-Hodgkin's Lymphoma

Last Updated: 2013-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-01-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether high dose chemotherapy plus bone marrow transplantation is more effective than high dose chemotherapy alone for intermediate- or high-grade non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of high dose chemotherapy with or without bone marrow transplantation in treating patients who have intermediate- or high-grade non-Hodgkin's lymphoma.

Detailed Description

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OBJECTIVES: I. Assess the value of early intensification with autologous bone marrow transplantation or stem cell support in patients with poor prognosis intermediate or high grade non-Hodgkin's lymphoma.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by age (under 50 vs 50 and over), bone marrow involvement (yes vs no), and country. All patients receive cyclophosphamide, doxorubicin, and vincristine on day 1 and prednisone on days 1-5. Courses repeat every 21 days. Patients receive a minimum of 6 courses of treatment in the absence of disease progression and unacceptable toxicity. Arm I: Patients receive carmustine IV over 2 hours on day 1 in week 9 or 10. Etoposide and cytarabine IV are administered over 30 minutes on days 2-5. Melphalan IV is administered over 5 minutes on day 6. Patients receive cryopreserved bone marrow or peripheral blood stem cells on day 7. Arm II: Patients continue conventional therapy. Patients are followed at 8-9 weeks and 6 months.

PROJECTED ACCRUAL: This study will accrue 500 patients.

Conditions

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Lymphoma

Keywords

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stage III grade 3 follicular lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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CHOP regimen

Intervention Type DRUG

carmustine

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

cytarabine

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

etoposide

Intervention Type DRUG

melphalan

Intervention Type DRUG

prednisone

Intervention Type DRUG

vincristine sulfate

Intervention Type DRUG

autologous bone marrow transplantation

Intervention Type PROCEDURE

peripheral blood stem cell transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed intermediate or high grade adult non-Hodgkin's lymphoma: Follicular large cell lymphoma Diffuse mixed cell lymphoma Diffuse large cell lymphoma Diffuse immunoblastic lymphoma Poor prognostic features defined as the presence of 2 or 3 of the following: Stage III/IV Lactase dehydrogenase greater than normal ECOG performance status 2-4 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: 16 to 65 Performance status: See Disease Characteristics Life expectancy: Not specified Hematopoietic: Not specified Hepatic: See Disease Characteristics Renal: Not specified Other: No other medical condition prohibiting intensive therapy

PRIOR CONCURRENT THERAPY: At least 5 years since prior systemic therapy for cancer

Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Principal Investigators

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David C. Linch

Role: STUDY_CHAIR

University College London Hospitals

Locations

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Charles University Hospital

Prague (Praha), , Czechia

Site Status

Aarhus Amtssygehus

Aarhus, , Denmark

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Rigshospitalet

Copenhagen, , Denmark

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Norwegian Radium Hospital

Oslo, , Norway

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Ullevall Hospital

Oslo, , Norway

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University of Tromso

Tromsø, , Norway

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Stoke Mandeville Hospital

Aylesbury-Buckinghamshire, England, United Kingdom

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Royal United Hospital

Bath, England, United Kingdom

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City Hospital - Birmingham

Birmingham, England, United Kingdom

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Birmingham Heartlands and Solihull NHS Trust (Teaching)

Birmingham, England, United Kingdom

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Southmead Hospital

Bristol, England, United Kingdom

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Bristol Haematology and Oncology Centre

Bristol, England, United Kingdom

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Queen's Hospital, Burton

Burton-on-Trent, England, United Kingdom

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Kent and Canterbury Hospital

Canterbury, England, United Kingdom

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Cheltenham General Hospital

Cheltenham, England, United Kingdom

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Countess of Chester Hospital

Chester, England, United Kingdom

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Derbyshire Royal Infirmary

Derby, England, United Kingdom

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Royal Free Hospital

Hampstead, London, England, United Kingdom

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Northwick Park Hospital

Harrow, England, United Kingdom

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Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, United Kingdom

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Ipswich Hospital NHS Trust

Ipswich, England, United Kingdom

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Leeds Teaching Hospital Trust

Leeds, England, United Kingdom

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University Hospitals of Leicester

Leicester, England, United Kingdom

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