AzTrials
AzTrials

LymphomaPhase 3NCT00049595

Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma

A Phase 3 study testing bleomycin sulfate, filgrastim and pegfilgrastim in people with Lymphoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 140 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating stage III or stage IV Hodgkin's lymphoma. Read more about this study

Who is it for?
Ages 16 to 60 years
Conditions the study is for
Lymphoma
What is being tested?
bleomycin sulfate, filgrastim and pegfilgrastim
Could I receive a placebo?
No, everyone receives an active treatment
How many people
552 participants
Where
140 sitesin 13 countries
Study dates
Aug 2002to Jan 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed Hodgkin's lymphoma
  • No lymphocyte predominant, nodular type (nodular paragranuloma)
  • Clinical stage III or IV disease
  • At least 1 bidimensionally measurable target lesion or extranodal lesion
  • International Prognostic Score of at least 3

PATIENT CHARACTERISTICS:

Age

  • 16 to 60

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC greater than 2,000/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic

  • No prior uncontrolled hepatitis B viral infection
  • Bilirubin no greater than 2.5 times normal (unless due to Hodgkin's lymphoma)

Renal

  • Creatinine no greater than 2.0 mg/dL (unless due to Hodgkin's lymphoma)

Cardiovascular

  • No severe cardiac disease that would limit normal life expectancy or preclude study
  • LVEF at least 50%

Pulmonary

  • No severe pulmonary disease that would limit normal life expectancy or preclude study
  • Respiratory function at least 30%

Other

  • HIV negative
  • HTLV1 negative
  • No severe active infection
  • No severe neurological or metabolic disease that would limit normal life expectancy or preclude study
  • No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • No psychological, familial, sociological, or geographical condition that would preclude study
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • No prior therapy for Hodgkin's lymphoma

Trial locations and contacts

140 sites in 13 countries.

140 sites in 13 countries

France55 sites

  • Centre Hospitalier d'Annecy

    Annecy, 74011 Cedex

  • Centre Hospitalier de la Cote Basque

    Bayonne, 64100

  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Institut Bergonie

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord Aquitaine

    Boucher, 33300

  • C.H. Bourg En Bresse

    Bourg-en-Bresse, 01012

  • CHU de Caen

    Caen, 14033

  • Polyclinique Du Parc

    Caen, 14052

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Hospitalier Regional de Chambery

    Chambéry, 73011

  • Hopital d'Instruction des Armees Percy

    Clamart, 92140

  • Hopital Antoine Beclere

    Clamart, 92141

  • CHR Clermont Ferrand, Hotel Dieu

    Clermont-Ferrand, 63003

  • Hopital Louis Pasteur

    Colmar, 68024

  • Centre Hospitalier Sud Francilien - Site Corbeil

    Corbeil, 91100

  • Centre Hospitalier Universitaire Henri Mondor

    Créteil, 94010

  • Hopital Du Bocage

    Dijon, 21034

  • Institut Prive de Cancerologie

    Grenoble, 38100

  • Hopital Andre Mignot

    Le Chesnay, 78157

  • Hopital Saint Antoine Lille

    Lille, 59000

  • Centre Hospitalier Regional et Universitaire de Lille

    Lille, 59037

  • Centre Hospital Regional Universitaire de Limoges

    Limoges, 87042

  • Centre Leon Berard

    Lyon, 69373

  • Hopital Edouard Herriot - Lyon

    Lyon, 69437

  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

    Marseille, 13273

  • Centre Hospitalier de Meaux

    Meaux, 77104

  • Centre Hospitalier Marc Jacquet

    Melun, 77011

  • Hopital Notre-Dame de Bon Secours

    Metz, 55038

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298

  • Centre Hospitalier de Mulhouse

    Mulhouse, 68051

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hopital de l'Archet CHU de Nice

    Nice, F-06202

  • Hotel Dieu de Paris

    Paris, 75181

  • Institut Curie Hopital

    Paris, 75248

  • Hopital Saint-Louis

    Paris, 75475

  • Hopital Saint Antoine

    Paris, 75571

  • CHU Pitie-Salpetriere

    Paris, 75651

  • Hopital Cochin

    Paris, 75674

  • Hopital Necker

    Paris, 75743

  • Hopital Haut Leveque

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Hopital Rene Dubos

    Pontoise, 95300

  • Institut Jean Godinot

    Reims, 51056

  • Hopital Sud

    Rennes, 35056

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Rene Huguenin

    Saint-Cloud, 92211

  • CHU Sainte-Etienne - Hopital Bellevue

    Saint-Etienne, 42055

  • Hopital de Saint Germain-en-Laye

    Saint-Germain-en-Laye, 78104

  • Hopital Universitaire Hautepierre

    Strasbourg, 67098

  • Hopital Foch

    Suresnes, 92151

  • Centre Hospitalier Valence

    Valence, 26000

  • Centre Hospitalier de Valenciennes

    Valenciennes, 59300

  • CHU de Nancy - Hopitaux de Brabois

    Vandœuvre-lès-Nancy, 54511

  • Hopital Paul Brousse

    Villejuif, 94804

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

Canada22 sites

  • Tom Baker Cancer Centre - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute at University of Alberta

    Edmonton, Alberta, T6G 1Z2

  • Northeastern Ontario Regional Cancer Centre

    Greater Sudbury, Ontario, P3E 5J1

  • Hopital Charles Lemoyne

    Greenfield Park, Quebec, J4V 2H1

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Cancer Centre of Southeastern Ontario at Kingston General Hospital

    Kingston, Ontario, K7L 5P9

  • London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, N6A 4L6

  • Moncton Hospital

    Moncton, New Brunswick, E1C 6ZB

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • Hopital Notre-Dame du CHUM

    Montreal, Quebec, H2L 4M1

  • CHUM - Hotel Dieu Hospital

    Montreal, Quebec, H2L-4M1

  • McGill Cancer Centre at McGill University

    Montreal, Quebec, H2W 1S6

  • Ottawa Hospital Regional Cancer Centre - General Campus

    Ottawa, Ontario, K1H 8L6

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, G1R 2J6

  • Hopital du Saint-Sacrement - Quebec

    Québec, Quebec, G1S 4L8

  • Saskatoon Cancer Centre at the University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 4H4

  • Doctor H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Edmond Odette Cancer Centre at Sunnybrook

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Windsor Regional Cancer Centre at Windsor Regional Hospital

    Windsor, Ontario, N8W 2X3

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

  • Centre Hospitalier De Dunkerque - CHD

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Netherlands16 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5211 NL

  • Meander Medisch Centrum

    Amersfoort, 3816 CP

  • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

    Amsterdam, 1066 CX

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 HA

  • Academisch Medisch Centrum at University of Amsterdam

    Amsterdam, 1105 AZ

  • Reinier de Graaf Group - Delft

    Delft, NL 2600 GA

  • Medisch Spectrum Twente

    Enschede, 7500 KA

  • University Medical Center Groningen

    Groningen, 9713 EZ

  • Atrium Medical Centre - Heerlen

    Heerlen, 6419 PC

  • Leiden University Medical Center

    Leiden, 2300 CA

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6202 AZ

  • Universitair Medisch Centrum St. Radboud - Nijmegen

    Nijmegen, NL-6500 HB

  • Saint Laurentius Ziekenhuis

    Roermond, 6043 CV

  • Daniel Den Hoed Cancer Center at Erasmus Medical Center

    Rotterdam, 3008 AE

  • HagaZiekenhuis - Locatie Leyenburg

    The Hague, 2545 CH

  • University Medical Center Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Belgium14 sites

  • Ziekenhuis Netwerk Antwerpen Middelheim

    Antwerp, 2020

  • AZ Sint-Jan

    Bruges, 8000

  • Institut Jules Bordet

    Brussels, 1000

  • Hopital Universitaire Erasme

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Centre Hospitalier Universitaire Brugmann

    Brussels, B 1020

  • Centre Hospitalier Notre Dame - Reine Fabiola

    Charleroi, 6000

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • Algemeen Ziekenhuis Sint Lucas

    Ghent, B-9000

  • Hopital de Jolimont

    Haine-Saint-Paul, 7100

  • U.Z. Gasthuisberg

    Leuven, B-3000

  • Centre Hospitalier Regional de la Citadelle

    Liège, 4000

  • H. Hartziekenhuis - Roeselaere

    Roeselare, 8800

  • Clinique Universitaire De Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

United Kingdom11 sites

  • Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

    Birmingham, England, B15 2TH

  • Raigmore Hospital

    Birmingham, England, B15 2TH

  • Kent and Canterbury Hospital

    Canterbury, England, CT2 7NR

  • Hull Royal Infirmary

    Hull, England, HU3 2KZ

  • Kettering General Hosptial

    Kettering, England, NNI6 8UZ

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

  • Middlesex Hospital

    London, England, WC1E 6HX

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England, HA6 2RN

  • Nottingham City Hospital NHS Trust

    Nottingham, England, NG5 1PB

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S1O 2SJ

  • Staffordshire General Hospital

    Stafford, England, ST16 3SA

Other trials in United Kingdom

Australia7 sites

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

  • Peter MacCallum Cancer Centre

    East Melbourne, Victoria, 3002

  • St. Vincent's Hospital - Melbourne

    Fitzroy, Victoria, 3065

  • Canberra Hospital

    Garran, Australian Capital Territory, 2606

  • Nepean Cancer Care Centre at Nepean Hospital

    Kingswood, New South Wales, 2747

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Westmead Institute for Cancer Research at Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Sweden6 sites

  • Sahlgrenska University Hospital

    Gothenburg (Goteborg), S-413 45

  • University Hospital of Linkoping

    Linköping, S-581 85

  • Lund University Hospital

    Lund, S-22185

  • Karolinska University Hospital - Huddinge

    Stockholm, S-141 86

  • Umea Universitet

    Umeå, S-901 85

  • Uppsala University Hospital

    Uppsala, S-75185

Other trials in Sweden

Spain3 sites

  • Hospital de la Santa Cruz i Sant Pau

    Barcelona, 08025

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, 08916

Other trials in Spain

New Zealand2 sites

  • Auckland City Hospital

    Auckland, 1

  • Waikato Hospital

    Hamilton, 2020

Other trials in New Zealand

Croatia1 site

  • University Hospital Rebro

    Zagreb, 41000

Other trials in Croatia

Czechia1 site

  • Thomayer's University Hospital

    Prague, 14000

Other trials in Czechia

Hungary1 site

  • National Institute of Oncology

    Budapest, 1122

Other trials in Hungary

Poland1 site

  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw

    Warsaw, 02-781

Other trials in Poland

About this study

Official title: BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating stage III or stage IV Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have stage III or stage IV Hodgkin's lymphoma.

Read the detailed description

OBJECTIVES:

  • Compare event-free survival of patients with stage III or IV Hodgkin's lymphoma treated with bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone vs doxorubicin, bleomycin, vinblastine, and dacarbazine.
  • Compare complete response, disease-free survival, and overall survival of patients treated with these regimens.
  • Compare quality of life of patients treated with these regimens.
  • Compare occurrence of second malignancies in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to International Prognostic Score (3 vs 4 or more) and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (BEACOPP): Patients receive doxorubicin IV over 5 minutes and cyclophosphamide IV on day 1; etoposide IV over 30 minutes on days 1-3; oral procarbazine on days 1-7; oral prednisone on days 1-14; and vincristine IV and bleomycin IV or intramuscularly (IM) on day 8. Patients may receive dexamethasone in place of prednisone. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 9 and continuing until blood counts recover or pegfilgrastim SC on day 9 only. Treatment repeats every 22 days for 8 courses (4 courses escalated dose followed by 4 courses baseline dose) in the absence of disease progression or unacceptable toxicity.
  • Arm II (ABVD): Patients receive doxorubicin IV over 5 minutes, bleomycin IV or IM, vinblastine IV, and dacarbazine IV over 5-10 minutes on days 1 and 15. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at the end of therapy, and then annually for 10 years.

Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 550 patients (225 per treatment arm) will be accrued for this study within 5.5 years.

Conditions
Lymphoma
Being tested
bleomycin sulfate, filgrastim, pegfilgrastim, ABVD regimen, BEACOPP regimen
Keywords
adult lymphocyte depletion Hodgkin lymphoma, adult mixed cellularity Hodgkin lymphoma, adult nodular sclerosis Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma
Medical subject headings
Lymphoma, Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00049595
Study groupRoleWhat they receive
ABVDActive comparator8 cycles of ABVD
Receives: Biological: bleomycin sulfate; Drug: ABVD regimen; Drug: dacarbazine; Drug: doxorubicin hydrochloride; Drug: vinblastine sulfate
BEACOPPExperimental4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline
Receives: Biological: bleomycin sulfate; Biological: filgrastim; Biological: pegfilgrastim; Drug: BEACOPP regimen; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: prednisone; Drug: procarbazine hydrochloride; Drug: vincristine sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival

    Measured: from randomization to early discontinuation of protocol treatment, no CR/CRu after 8 cycles, relapse, progression or death

Secondary outcomes (4)

  1. Complete response as assessed by Cheson criteria adapted to Hodgkin's lymphoma

    Measured: from randomization till end of treatment

  2. Disease-free survival in patients with complete response

    Measured: from the day of first documentation of CR to the day of relapse

  3. Overall survival

    Measured: from the date of randomization to the date of death

  4. Quality of life as assessed by European Organization for Research of the Treatment of Cancer (EORTC) Quality of Life Questionnaire (QoLQ) C30 version 3.0

    Measured: from one week prior to randomization till 10 years after end of treatment or death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startAug 2002
  3. Primary completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
552 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00049595
Sponsor's protocol ID
EORTC-20012
Other IDs
EORTC-20012, GELA-EORTC-20012, BNLI-EORTC-20012, GELCAB-EORTC-20012, NORDICLG-EORTC-20012, CAN-NCIC-EORTC-20012, ALLG-HD04, 2004-001558-10
Status last verified
Aug 2025
First submitted
12 Nov 2002
Last updated
5 Aug 2025
Results posted
No

Publications

  • Carde P, Karrasch M, Fortpied C, Brice P, Khaled H, Casasnovas O, Caillot D, Gaillard I, Bologna S, Ferme C, Lugtenburg PJ, Morschhauser F, Aurer I, Coiffier B, Meyer R, Seftel M, Wolf M, Glimelius B, Sureda A, Mounier N. Eight Cycles of ABVD Versus Four Cycles of BEACOPPescalated Plus Four Cycles of BEACOPPbaseline in Stage III to IV, International Prognostic Score >/= 3, High-Risk Hodgkin Lymphoma: First Results of the Phase III EORTC 20012 Intergroup Trial. J Clin Oncol. 2016 Jun 10;34(17):2028-36. doi: 10.1200/JCO.2015.64.5648. Epub 2016 Apr 25.

    PubMed 27114593

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bleomycin sulfate, filgrastim and pegfilgrastim in people with Lymphoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 140 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in France, Canada, Netherlands, Belgium, United Kingdom and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free survival (time frame: from randomization to early discontinuation of protocol treatment, no CR/CRu after 8 cycles, relapse, progression or death). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00049595, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.

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