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LymphomaPhase 3NCT00005589

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

A Phase 3 study testing filgrastim, rituximab and carmustine in people with Lymphoma, run by EBMT Solid Tumors Working Party at 131 sites in 17 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. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
filgrastim, rituximab and carmustine
Type of treatment
Surgery or procedure
How many people
460 participants
Where
131 sitesin 17 countries
Study dates
Oct 1999to Apr 2013
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Relapsed or resistant follicular non-Hodgkin's lymphoma (NHL)
  • No evidence of transformation to high grade or diffuse large B-cell NHL
  • CD20 positive with no evidence of transformation
  • Achievement of complete remission (CR) or very good partial remission (VGPR) following reinduction chemotherapy with any standard regimen
  • Includes patients who fail to respond to first-line chemotherapy but who achieve CR or VGPR after proceeding directly to second-line chemotherapy
  • Platelet count greater than 100,000/mm^3 after induction chemotherapy and before randomization
  • No CNS involvement

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Bilirubin normal
  • ALT no greater than 2 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2 times ULN
  • Hepatitis B negative
  • Hepatitis C negative

Renal:

  • Creatinine no greater than 2 times ULN
  • BUN no greater than 2 times ULN

Cardiovascular:

  • No inadequate cardiac function

Pulmonary:

  • No inadequate pulmonary function

Other:

  • Not pregnant or nursing
  • HIV negative
  • No other uncontrolled serious medical conditions
  • No other malignancy within the past 5 years except nonmelanoma skin tumors or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • More than 12 months since prior CD20 therapy, including rituximab
  • No prior peripheral blood stem cell transplantation

Chemotherapy:

  • See Disease Characteristics
  • No more than 3 prior chemotherapy regimens for NHL

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to greater than 30% of bone marrow

Surgery:

  • Not specified

Trial locations and contacts

131 sites in 17 countries.

131 sites in 17 countries

United Kingdom39 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

  • Stoke Mandeville Hospital

    Aylesbury-Buckinghamshire, England, HP21 8AL

  • Ysbyty Gwynedd

    Bangor, Wales, LL57 2PW

  • Royal United Hospital

    Bath, England, BA1 3NG

  • Centre for Cancer Research and Cell Biology at Belfast City Hospital

    Belfast, Northern Ireland, BT9 7AB

  • Birmingham Heartlands Hospital

    Birmingham, England, B9 5SS

  • Royal Bournemouth Hospital

    Bournemouth, England, BH7 7DW

  • Bristol Haematology and Oncology Centre

    Bristol, England, BS2 8ED

  • Prince Philip Hospital

    Dyfed, Wales, SA14 8QF

  • Royal Devon and Exeter Hospital

    Exeter, England, EX2 5DW

  • Royal Infirmary - Castle

    Glasgow, Scotland, G4 0SF

  • Huddersfield Royal Infirmary

    Huddersfield, West Yorks, England, HD3 3EA

  • Hull Royal Infirmary

    Hull, England, HU3 2KZ

  • Kettering General Hosptial

    Kettering, Northants, England, NNI6 8UZ

  • Clinical Trials and Research Unit of the University of Leeds

    Leeds, England, LS2 9N9

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

  • Royal Liverpool and Broadgreen Hospitals NHS Trust

    Liverpool, England, L7 8XP

  • Liverpool University Hospital

    Liverpool, England, L9 7AL

  • Saint Bartholomew's Hospital

    London, England, EC1A 7BE

  • St. Thomas' Hospital

    London, England, SE1 7EH

  • Clinique Sainte Elisabeth

    London, England, SW17 ORE

  • St. Georges, University of London

    London, England, SW17 ORE

  • University College Hospital - London

    London, England, WC1E 6AU

  • Middlesex Hospital

    London, England, WC1E 6HX

  • James Paget Hospital

    Norfolk, England, NR31 6LA

  • Nottingham City Hospital NHS Trust

    Nottingham, England, NG5 1PB

  • Oxford Radcliffe Hospital

    Oxford, England, 0X3 9DU

  • Pontefract General Infirmary

    Pontefract West Yorkshire, England, WF8 1PL

  • Rotherham District General Hospital - NHS Trust

    Rotherham, England, S60 2UD

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S1O 2SJ

  • Southampton University Hospital NHS Trust

    Southampton, England, SO16 6YD

  • Staffordshire General Hospital

    Stafford, England, ST16 3SA

  • Royal Marsden NHS Foundation Trust - Surrey

    Sutton, England, SM2 5PT

  • Singleton Hospital of the Swansea NHS Trust

    Swansea, Wales, SA2 8QA

  • Great Western Hospital

    Swindon, England, SN3 6BB

  • Princess Margaret Hospital

    Swindon, England, SN3 6BB

  • Hillingdon Hospital

    Uxbridge, England, UB8 3NN

  • Pinderfields Hospital NHS Trust

    Wakefield, Scotland, WF1 4DG

  • Sandwell General Hospital

    West Bromwich, England, B71 4HJ

Other trials in United Kingdom

Spain34 sites

  • Hospital Juan Canalejo

    A Coruña, 15000

  • Hospital General - Alicante

    Alicante, 3010

  • Hospital de Cruces

    Barakaldo Bilbao, E-48903

  • Centro Medico Teknon

    Barcelona, 08022

  • Hospital de la Santa Cruz i Sant Pau

    Barcelona, 08025

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, 08916

  • Hospital San Pedro de Alcantara

    Cáceres, 10000

  • Hospital Universitario Puerta Del Mar

    Cadiz, 11000

  • Hospital General de Castellon

    Castellon, 12004

  • Hospital Virgen de la Arrixaca

    El Palmar, 30120

  • Hospital de Galdakao

    Galdakao Vizcaya, 48000

  • Hospital Virgen de las Nieves

    Granada, 18014

  • Hospital Cuidad de Jaen

    Jaén, E-23006

  • Hospital de Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria, 350311

  • Hospital de la Princesa

    Madrid, 28006

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario de Getafe

    Madrid, 28905

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

  • Hospital Universitario Central de Asturias

    Oviedo, 33006

  • Hospital Son Dureta

    Palma de Mallorca, 07014

  • Hospital Virgen de la Vega

    Salamanca, 37007

  • University Hospital - Salamanca

    Salamanca, 37007

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Hospital Universidad Virgen Del Rocio

    Seville, E- 41013

  • Hospital Mutua de Terrassa

    Terrassa, 08221

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Unidad De Oncol/Hemat. Hospital

    Valencia, 46017

  • Complexo Hospitalario Xeral de Vigo

    Vigo Pontevedra, 36204

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50006

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

France15 sites

  • Centre Hospitalier Regional et Universitaire d'Angers

    Angers, 49033

  • Polyclinique Du Parc

    Caen, 14052

  • Centre Regional Francois Baclesse

    Caen, 14076

  • CHU de Grenoble - Hopital de la Tronche

    Grenoble, 38043

  • Centre Leon Berard

    Lyon, 69373

  • Polyclinique Saint Jean

    Melun, 77000

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

    Montpellier, 34298

  • CHR Hotel Dieu

    Nantes, 44093

  • Hopital Saint-Louis

    Paris, 75475

  • CHU Pitie-Salpetriere

    Paris, 75651

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Hospitalier Universitaire de Rennes

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Hospitalier Universitaire Bretonneau de Tours

    Tours, 37044

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

Germany9 sites

  • Klinikum Augsburg

    Augsburg, DOH-86156

  • DIAKO Ev. Diakonie Krankenhaus gGmbH

    Bremen, D-28239

  • Universitaetsklinikum Goettingen

    Göttingen, D-37075

  • Asklepios Klinik St. Georg

    Hamburg, D-20099

  • Medical University Hospital Homburg

    Homburg, 66421

  • Universitaetsklinikum des Saarlandes

    Homburg, D-66424

  • Klinikum Nuernberg - Klinikum Nord

    Nuremberg, D-90419

  • Klinikum Oldenburg

    Oldenburg, D-26133

  • Southwest German Cancer Center at Eberhard-Karls-University

    Tübingen, D-72076

Other trials in Germany

Australia8 sites

  • Royal Adelaide Hospital Cancer Centre

    Adelaide, South Australia, 5000

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4029

  • Fremantle Hospital

    Fremantle, Western Australia, 6160

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Sydney Cancer Centre at Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050

  • Westmead Institute for Cancer Research at Westmead Hospital

    Westmead, New South Wales, 2145

  • Queen Elizabeth Hospital

    Woodville, South Australia, 5011

Other trials in Australia

Belgium8 sites

  • Ziekenhuis Netwerk Antwerpen Middelheim

    Antwerp, B-2020

  • Institut Jules Bordet

    Brussels, 1000

  • Academisch Ziekenhuis der Vrije Universiteit Brussel

    Brussels, 1090

  • Universitair Ziekenhuis Gent

    Ghent, B-9000

  • U.Z. Gasthuisberg

    Leuven, B-3000

  • CHU Liege - Domaine Universitaire du Sart Tilman

    Liège, B-4000

  • Clinique Universitaire De Mont-Godinne

    Mont-Godinne Yvoir, 5530

  • H. Hartziekenhuis - Roeselaere.

    Roeselaere, 8800

Other trials in Belgium

Denmark3 sites

  • Aalborg Hospital

    Aalborg, DK-9000

  • Rigshospitalet - Copenhagen University Hospital

    Copenhagen, 2100

  • Odense University Hospital

    Odense, DK-5000

Other trials in Denmark

New Zealand3 sites

  • Auckland City Hospital

    Auckland, 1

  • Canterbury Health Laboratories

    Christchurch

  • Waikato Hospital

    Hamilton, 2020

Other trials in New Zealand

Canada2 sites

  • Tom Baker Cancer Centre - Calgary

    Calgary, Alberta, T2N 4N2

  • Ottawa Hospital Regional Cancer Centre - General Campus

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

Poland2 sites

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

    Warsaw, 02-781

  • K. Dluski Hospital-Medical Academy

    Wroclaw, 53 439

Other trials in Poland

Switzerland2 sites

  • Kantonsspital Bruderholz

    Bruderholz, CH-4101

  • UniversitaetsSpital Zuerich

    Zurich, CH-8091

Other trials in Switzerland

Austria1 site

  • Allgemeines Krankenhaus - Universitatskliniken

    Vienna, A-1090

Other trials in Austria

Czechia1 site

  • University Hospital Kralovske Vinohr

    Prague, 10034

Other trials in Czechia

Israel1 site

  • Chaim Sheba Medical Center

    Tel HaShomer, 52621

Other trials in Israel

Portugal1 site

  • Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.

    Lisbon, 1099-023 Codex

Other trials in Portugal

Sweden1 site

  • Karolinska University Hospital - Huddinge

    Stockholm, SE-141 86

Other trials in Sweden

Turkey (Türkiye)1 site

  • Ibn-i Sina Hospital

    Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

Official title: Randomized Study of Rituximab (Mabthera) in Patients With Relapsed Follicular Lymphoma Prior to High-Dose Therapy as In Vivo Purging and to Maintain Remission Following High-Dose Therapy

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy plus peripheral stem cell transplantation is more effective with or without rituximab for non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy and peripheral stem cell transplantation together with rituximab to see how well it works compared to combination chemotherapy and peripheral stem cell transplantation alone in treating patients with relapsed non-Hodgkin's lymphoma.

Read the detailed description

OBJECTIVES:

  • Determine the effects of in vivo rituximab purging and maintenance on progression-free survival in patients with relapsed or resistant follicular non-Hodgkin's lymphoma undergoing high-dose chemotherapy.
  • Determine the effects of this regimen on response rate and overall survival in this patient population.
  • Determine the effects of in vivo purging with rituximab on molecular remission rates in the hematopoietic product and the patients.
  • Determine the safety of rituximab in the transplant setting.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to type of remission (complete vs good partial) and which remission (second vs third). Patients are randomized to one of four treatment arms.

All patients receive induction chemotherapy comprising cyclophosphamide IV over 3-4 hours on day 0 or a standard induction chemotherapy regimen. Filgrastim (G-CSF) is administered subcutaneously daily beginning on day 1.

Patients are then randomized to receive either in vivo rituximab purging or no purging following restaging after completion of induction. For those patients receiving purging (arms I and II), rituximab is administered IV once weekly for 4 weeks.

Peripheral blood stem cells (PBSC) are collected between days 8 and 12 post induction chemotherapy. Within 4 weeks of PBSC collection, patients receive carmustine IV over 2 hours on day -6, etoposide IV over 2 hours on days -5 to -2, cytarabine IV over 5 minutes twice daily on days -5 to -2, and melphalan IV over 10-15 minutes on day -1. (Alternatively, high dose cyclophosphamide and total body irradiation beginning 2-4 weeks after cyclophosphamide or standard induction chemotherapy priming is also allowed.) PBSC are reinfused on day 0.

Patients are further randomized to receive either rituximab maintenance or observation only. For those patients receiving maintenance (arms I and III), rituximab is administered IV once every 2 months for 4 doses beginning 30 days after PBSC reinfusion.

Patients are followed at 30 days, 3, 6, 9, and 12 months after PBSC transplant, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 460 patients (115 per treatment arm) will be accrued for this study within 5 years.

Conditions
Lymphoma
Being tested
filgrastim, rituximab, carmustine, cyclophosphamide, cytarabine
Keywords
recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma
Medical subject headings
Lymphoma, Lymphoma, Follicular

What participants receive

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

What is being measured

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

  1. Time to disease progression

Secondary outcomes (3)

  1. Response rate and survival

  2. Molecular remission rates

  3. Safety

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 startOct 1999
  3. Study completionApr 2013

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
Masking
None (open label)
Enrolment
460 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005589
Sponsor's protocol ID
CDR0000067665
Other IDs
EBMT-EBMTLYM1, BNLI-EBMT-EBMTLYM1, EU-99050
Status last verified
Mar 2007
First submitted
2 May 2000
Last updated
17 Sep 2013
Results posted
No

Publications

  • Pettengell R, Schmitz N, Gisselbrecht C, Smith G, Patton WN, Metzner B, Caballero D, Tilly H, Walewski JA, Bence-Bruckler I, To B, Geisler CH, Schots R, Kimby E, Taverna CJ, Kozak T, Dreger P, Uddin R, Ruiz de Elvira C, Goldstone AH. Rituximab purging and/or maintenance in patients undergoing autologous transplantation for relapsed follicular lymphoma: a prospective randomized trial from the lymphoma working party of the European group for blood and marrow transplantation. J Clin Oncol. 2013 May 1;31(13):1624-30. doi: 10.1200/JCO.2012.47.1862. Epub 2013 Apr 1.

    PubMed 23547078

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing filgrastim, rituximab and carmustine in people with Lymphoma, run by EBMT Solid Tumors Working Party at 131 sites in 17 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 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 131 sites in United Kingdom, Spain, France, Germany, Australia and 12 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?

Time to disease progression. 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 NCT00005589, 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 17 Sep 2013.

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Clinical Trial NCT00005589 | AzTrials