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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
filgrastim
rituximab
carmustine
cyclophosphamide
cytarabine
etoposide
melphalan
bone marrow ablation with stem cell support
peripheral blood stem cell transplantation
Sponsored by
EBMT Solid Tumors Working Party
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sydney Cancer Centre at Royal Prince Alfred Hospital
  • Westmead Institute for Cancer Research at Westmead Hospital
  • Royal Brisbane and Women's Hospital
  • Royal Adelaide Hospital Cancer Centre
  • Queen Elizabeth Hospital
  • Royal Melbourne Hospital
  • Fremantle Hospital
  • Royal Perth Hospital
  • Allgemeines Krankenhaus - Universitatskliniken
  • Ziekenhuis Netwerk Antwerpen Middelheim
  • Institut Jules Bordet
  • Academisch Ziekenhuis der Vrije Universiteit Brussel
  • Universitair Ziekenhuis Gent
  • U.Z. Gasthuisberg
  • CHU Liege - Domaine Universitaire du Sart Tilman
  • Clinique Universitaire De Mont-Godinne
  • H. Hartziekenhuis - Roeselaere.
  • Tom Baker Cancer Centre - Calgary
  • Ottawa Hospital Regional Cancer Centre - General Campus
  • University Hospital Kralovske Vinohr
  • Aalborg Hospital
  • Rigshospitalet - Copenhagen University Hospital
  • Odense University Hospital
  • Centre Hospitalier Regional et Universitaire d'Angers
  • Polyclinique Du Parc
  • Centre Regional Francois Baclesse
  • CHU de Grenoble - Hopital de la Tronche
  • Centre Leon Berard
  • Polyclinique Saint Jean
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • CHR Hotel Dieu
  • Hopital Saint-Louis
  • CHU Pitie-Salpetriere
  • Centre Hospitalier Lyon Sud
  • Centre Hospitalier Universitaire de Rennes
  • Centre Henri Becquerel
  • Centre Hospitalier Universitaire Bretonneau de Tours
  • Institut Gustave Roussy
  • Klinikum Augsburg
  • DIAKO Ev. Diakonie Krankenhaus gGmbH
  • Universitaetsklinikum Goettingen
  • Asklepios Klinik St. Georg
  • Medical University Hospital Homburg
  • Universitaetsklinikum des Saarlandes
  • Klinikum Nuernberg - Klinikum Nord
  • Klinikum Oldenburg
  • Southwest German Cancer Center at Eberhard-Karls-University
  • Chaim Sheba Medical Center
  • Auckland City Hospital
  • Canterbury Health Laboratories
  • Waikato Hospital
  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
  • K. Dluski Hospital-Medical Academy
  • Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.
  • Hospital General - Alicante
  • Hospital de Cruces
  • Centro Medico Teknon
  • Hospital de la Santa Cruz i Sant Pau
  • Hospital Clinic de Barcelona
  • Hospital Universitari Germans Trias i Pujol
  • Hospital San Pedro de Alcantara
  • Hospital Universitario Puerta Del Mar
  • Hospital General de Castellon
  • Hospital Virgen de la Arrixaca
  • Hospital de Galdakao
  • Hospital Virgen de las Nieves
  • Hospital Cuidad de Jaen
  • Hospital Juan Canalejo
  • Hospital de Gran Canaria Dr. Negrin
  • Hospital de la Princesa
  • Hospital General Universitario Gregorio Maranon
  • Hospital Ramon y Cajal
  • Hospital Universitario San Carlos
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario de Getafe
  • Hospital General Universitario Morales Meseguer
  • Hospital Universitario Central de Asturias
  • Hospital Son Dureta
  • Hospital Virgen de la Vega
  • University Hospital - Salamanca
  • Hospital Universitario Marques de Valdecilla
  • Hospital Universidad Virgen Del Rocio
  • Hospital Mutua de Terrassa
  • Hospital Clinico Universitario de Valencia
  • Unidad De Oncol/Hemat. Hospital
  • Complexo Hospitalario Xeral de Vigo
  • Hospital Clinico Universitario Lozano Blesa
  • Hospital Universitario Miguel Servet
  • Karolinska University Hospital - Huddinge
  • Kantonsspital Bruderholz
  • UniversitaetsSpital Zuerich
  • Ibn-i Sina Hospital
  • Stoke Mandeville Hospital
  • Royal United Hospital
  • Birmingham Heartlands Hospital
  • Royal Bournemouth Hospital
  • Bristol Haematology and Oncology Centre
  • Royal Devon and Exeter Hospital
  • Huddersfield Royal Infirmary
  • Hull Royal Infirmary
  • Kettering General Hosptial
  • Clinical Trials and Research Unit of the University of Leeds
  • Leicester Royal Infirmary
  • Royal Liverpool and Broadgreen Hospitals NHS Trust
  • Liverpool University Hospital
  • Saint Bartholomew's Hospital
  • St. Thomas' Hospital
  • Clinique Sainte Elisabeth
  • St. Georges, University of London
  • University College Hospital - London
  • Middlesex Hospital
  • James Paget Hospital
  • Nottingham City Hospital NHS Trust
  • Oxford Radcliffe Hospital
  • Pontefract General Infirmary
  • Rotherham District General Hospital - NHS Trust
  • Cancer Research Centre at Weston Park Hospital
  • Southampton University Hospital NHS Trust
  • Staffordshire General Hospital
  • Royal Marsden NHS Foundation Trust - Surrey
  • Great Western Hospital
  • Princess Margaret Hospital
  • Hillingdon Hospital
  • Sandwell General Hospital
  • Centre for Cancer Research and Cell Biology at Belfast City Hospital
  • Aberdeen Royal Infirmary
  • Royal Infirmary - Castle
  • Pinderfields Hospital NHS Trust
  • Ysbyty Gwynedd
  • Prince Philip Hospital
  • Singleton Hospital of the Swansea NHS Trust

Outcomes

Primary Outcome Measures

Time to disease progression

Secondary Outcome Measures

Response rate and survival
Molecular remission rates
Safety

Full Information

First Posted
May 2, 2000
Last Updated
September 16, 2013
Sponsor
EBMT Solid Tumors Working Party
Collaborators
Lymphoma Trials Office
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1. Study Identification

Unique Protocol Identification Number
NCT00005589
Brief Title
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
EBMT Solid Tumors Working Party
Collaborators
Lymphoma Trials Office

4. Oversight

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
460 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Drug
Intervention Name(s)
carmustine
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
melphalan
Intervention Type
Procedure
Intervention Name(s)
bone marrow ablation with stem cell support
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Primary Outcome Measure Information:
Title
Time to disease progression
Secondary Outcome Measure Information:
Title
Response rate and survival
Title
Molecular remission rates
Title
Safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth Pettengell, MD
Organizational Affiliation
St George's, University of London
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David C. Linch
Organizational Affiliation
Middlesex Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sydney Cancer Centre at Royal Prince Alfred Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Westmead Institute for Cancer Research at Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Royal Adelaide Hospital Cancer Centre
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Queen Elizabeth Hospital
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Fremantle Hospital
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Allgemeines Krankenhaus - Universitatskliniken
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Ziekenhuis Netwerk Antwerpen Middelheim
City
Antwerpen
ZIP/Postal Code
B-2020
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Academisch Ziekenhuis der Vrije Universiteit Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Ghent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
CHU Liege - Domaine Universitaire du Sart Tilman
City
Liege
ZIP/Postal Code
B-4000
Country
Belgium
Facility Name
Clinique Universitaire De Mont-Godinne
City
Mont-Godinne Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
H. Hartziekenhuis - Roeselaere.
City
Roeselaere
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Tom Baker Cancer Centre - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Ottawa Hospital Regional Cancer Centre - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
University Hospital Kralovske Vinohr
City
Prague
ZIP/Postal Code
10034
Country
Czech Republic
Facility Name
Aalborg Hospital
City
Aalborg
ZIP/Postal Code
DK-9000
Country
Denmark
Facility Name
Rigshospitalet - Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
Centre Hospitalier Regional et Universitaire d'Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Polyclinique Du Parc
City
Caen
ZIP/Postal Code
14052
Country
France
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
CHU de Grenoble - Hopital de la Tronche
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Polyclinique Saint Jean
City
Melun
ZIP/Postal Code
77000
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
CHR Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
CHU Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Hospitalier Universitaire de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Centre Hospitalier Universitaire Bretonneau de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Facility Name
Klinikum Augsburg
City
Augsburg
ZIP/Postal Code
DOH-86156
Country
Germany
Facility Name
DIAKO Ev. Diakonie Krankenhaus gGmbH
City
Bremen
ZIP/Postal Code
D-28239
Country
Germany
Facility Name
Universitaetsklinikum Goettingen
City
Goettingen
ZIP/Postal Code
D-37075
Country
Germany
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
D-20099
Country
Germany
Facility Name
Medical University Hospital Homburg
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Universitaetsklinikum des Saarlandes
City
Homburg
ZIP/Postal Code
D-66424
Country
Germany
Facility Name
Klinikum Nuernberg - Klinikum Nord
City
Nuernberg
ZIP/Postal Code
D-90419
Country
Germany
Facility Name
Klinikum Oldenburg
City
Oldenburg
ZIP/Postal Code
D-26133
Country
Germany
Facility Name
Southwest German Cancer Center at Eberhard-Karls-University
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1
Country
New Zealand
Facility Name
Canterbury Health Laboratories
City
Christchurch
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
2020
Country
New Zealand
Facility Name
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
K. Dluski Hospital-Medical Academy
City
Wroclaw
ZIP/Postal Code
53 439
Country
Poland
Facility Name
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.
City
Lisboa
ZIP/Postal Code
1099-023 Codex
Country
Portugal
Facility Name
Hospital General - Alicante
City
Alicante
ZIP/Postal Code
3010
Country
Spain
Facility Name
Hospital de Cruces
City
Barakaldo Bilbao
ZIP/Postal Code
E-48903
Country
Spain
Facility Name
Centro Medico Teknon
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Hospital de la Santa Cruz i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital San Pedro de Alcantara
City
Caceres
ZIP/Postal Code
10000
Country
Spain
Facility Name
Hospital Universitario Puerta Del Mar
City
Cadiz
ZIP/Postal Code
11000
Country
Spain
Facility Name
Hospital General de Castellon
City
Castellon
ZIP/Postal Code
12004
Country
Spain
Facility Name
Hospital Virgen de la Arrixaca
City
El Palmar
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital de Galdakao
City
Galdakao Vizcaya
ZIP/Postal Code
48000
Country
Spain
Facility Name
Hospital Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital Cuidad de Jaen
City
Jaen
ZIP/Postal Code
E-23006
Country
Spain
Facility Name
Hospital Juan Canalejo
City
La Coruna
ZIP/Postal Code
15000
Country
Spain
Facility Name
Hospital de Gran Canaria Dr. Negrin
City
Las Palmas de Gran Canaria
ZIP/Postal Code
350311
Country
Spain
Facility Name
Hospital de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario de Getafe
City
Madrid
ZIP/Postal Code
28905
Country
Spain
Facility Name
Hospital General Universitario Morales Meseguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Hospital Son Dureta
City
Palma De Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
Hospital Virgen de la Vega
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
University Hospital - Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universidad Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
E- 41013
Country
Spain
Facility Name
Hospital Mutua de Terrassa
City
Terrassa
ZIP/Postal Code
08221
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Unidad De Oncol/Hemat. Hospital
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Complexo Hospitalario Xeral de Vigo
City
Vigo Pontevedra
ZIP/Postal Code
36204
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50006
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Karolinska University Hospital - Huddinge
City
Stockholm
ZIP/Postal Code
SE-141 86
Country
Sweden
Facility Name
Kantonsspital Bruderholz
City
Bruderholz
ZIP/Postal Code
CH-4101
Country
Switzerland
Facility Name
UniversitaetsSpital Zuerich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
Ibn-i Sina Hospital
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Stoke Mandeville Hospital
City
Aylesbury-Buckinghamshire
State/Province
England
ZIP/Postal Code
HP21 8AL
Country
United Kingdom
Facility Name
Royal United Hospital
City
Bath
State/Province
England
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
State/Province
England
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
State/Province
England
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Huddersfield Royal Infirmary
City
Huddersfield, West Yorks
State/Province
England
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
Facility Name
Hull Royal Infirmary
City
Hull
State/Province
England
ZIP/Postal Code
HU3 2KZ
Country
United Kingdom
Facility Name
Kettering General Hosptial
City
Kettering, Northants
State/Province
England
ZIP/Postal Code
NNI6 8UZ
Country
United Kingdom
Facility Name
Clinical Trials and Research Unit of the University of Leeds
City
Leeds
State/Province
England
ZIP/Postal Code
LS2 9N9
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Royal Liverpool and Broadgreen Hospitals NHS Trust
City
Liverpool
State/Province
England
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Liverpool University Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Saint Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
St. Thomas' Hospital
City
London
State/Province
England
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Clinique Sainte Elisabeth
City
London
State/Province
England
ZIP/Postal Code
SW17 ORE
Country
United Kingdom
Facility Name
St. Georges, University of London
City
London
State/Province
England
ZIP/Postal Code
SW17 ORE
Country
United Kingdom
Facility Name
University College Hospital - London
City
London
State/Province
England
ZIP/Postal Code
WC1E 6AU
Country
United Kingdom
Facility Name
Middlesex Hospital
City
London
State/Province
England
ZIP/Postal Code
WC1E 6HX
Country
United Kingdom
Facility Name
James Paget Hospital
City
Norfolk
State/Province
England
ZIP/Postal Code
NR31 6LA
Country
United Kingdom
Facility Name
Nottingham City Hospital NHS Trust
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 9DU
Country
United Kingdom
Facility Name
Pontefract General Infirmary
City
Pontefract West Yorkshire
State/Province
England
ZIP/Postal Code
WF8 1PL
Country
United Kingdom
Facility Name
Rotherham District General Hospital - NHS Trust
City
Rotherham
State/Province
England
ZIP/Postal Code
S60 2UD
Country
United Kingdom
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Facility Name
Southampton University Hospital NHS Trust
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Staffordshire General Hospital
City
Stafford
State/Province
England
ZIP/Postal Code
ST16 3SA
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Great Western Hospital
City
Swindon
State/Province
England
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
Facility Name
Princess Margaret Hospital
City
Swindon
State/Province
England
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
Facility Name
Hillingdon Hospital
City
Uxbridge
State/Province
England
ZIP/Postal Code
UB8 3NN
Country
United Kingdom
Facility Name
Sandwell General Hospital
City
West Bromwich
State/Province
England
ZIP/Postal Code
B71 4HJ
Country
United Kingdom
Facility Name
Centre for Cancer Research and Cell Biology at Belfast City Hospital
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Royal Infirmary - Castle
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
Pinderfields Hospital NHS Trust
City
Wakefield
State/Province
Scotland
ZIP/Postal Code
WF1 4DG
Country
United Kingdom
Facility Name
Ysbyty Gwynedd
City
Bangor
State/Province
Wales
ZIP/Postal Code
LL57 2PW
Country
United Kingdom
Facility Name
Prince Philip Hospital
City
Dyfed
State/Province
Wales
ZIP/Postal Code
SA14 8QF
Country
United Kingdom
Facility Name
Singleton Hospital of the Swansea NHS Trust
City
Swansea
State/Province
Wales
ZIP/Postal Code
SA2 8QA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23547078
Citation
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.
Results Reference
derived

Learn more about this trial

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

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