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A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13

Primary Purpose

Diffuse Large B-Cell Lymphoma (DLBCL), Follicular NHL Grade 3b

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rituximab
Sponsored by
Arbeitsgemeinschaft medikamentoese Tumortherapie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma (DLBCL) focused on measuring DLBCL, NHL 13, Rituximab, maintenance

Eligibility Criteria

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

Inclusion Criteria:

  • 4 to 8 cycles R-CHOP/like, total of 8x Rituximab
  • CR, CRu
  • ECOG/ 0.1 or 2
  • Known IPI at time of diagnosis
  • Age > 18 years
  • Negative pregnancy test
  • Men must agree not to father a child during the therapy

Exclusion Criteria:

  • Transformed lymphoma
  • Secondary malignancy
  • Evidence of CNS - involvement
  • Significant cardiac disease
  • Creatinine > 2.0 mg/dl
  • HIV, Hepatitis positive

Sites / Locations

  • Border Medical Oncology
  • Concord Repatriation General Hospital
  • Gosford Hospital
  • Greenslopes Hospital
  • Prince of Wales Hospital
  • Krankenhaus Oberpullendorf
  • Krankenhaus Oberwart
  • A.ö. Krankenhaus der Landeshauptstadt St. Pölten
  • A.ö. Krankenhaus der Statutarstadt Wr. Neustadt
  • Krankenhaus d. Barmherzigen Schwestern Linz
  • Krankenhaus der Elisabethinen Linz
  • KH Barmherzige Schwestern Ried
  • Klinikum Kreuzschwestern Wels GmbH
  • A.ö. Landeskrankenhaus Steyr
  • Bezirkskrankenhaus Kufstein
  • A.oe.Bezirkskrankenhaus Hall
  • Universitätsklinik Innsbruck/ Klinik für Innere Medizin
  • Landeskrankenhaus Feldkirch
  • LKH Bregenz
  • KH Dornbirn
  • A.ö. Landeskrankenhaus Fürstenfeld
  • Universitätsklinikum Graz
  • LKH Hohenems
  • Universitaetsklinik Innsbruck
  • Landeskrankenhaus Klagenfurt
  • A.ö. Landeskrankenhaus Leoben
  • Krankenhaus der Stadt Linz
  • LKH Weinviertel Mistelbach
  • St. Johanns LK
  • KH Barmherzige Brüder
  • Krankenhaus der Stadt Wien Rudolfsstiftung
  • AKH Wien / Hämatologie u. Hämostaseologie
  • Kaiser-Franz-Josef-Spital
  • Krankenhaus der Stadt Wien Lainz
  • Hanusch-Krankenhaus
  • Wilhelminenspital
  • Sozialmedizinisches Zentrum Ost - Donauspital
  • LKH Villach
  • LKH Vöcklabruck
  • KH Waidhofen/Thaya
  • BKH Zams
  • Clinical Centre University Sarajevo
  • University Center Tuzla
  • Centro Goiano de Oncologia
  • Hospital Santa Izabel
  • Hospital das Clinicas FMUSP
  • Hospital deas Clinical FMUSP
  • UMHAT "St. George" Plodviv
  • Nat. Centre of Hematology and Transfusiology Sofia
  • MHAT "St. Marina" Varna
  • Chinese PLA General hospital
  • West China Hospital of Sichuan University
  • Harbin Institue
  • Jiangsu Cancer Hospital
  • Changhai Hospital
  • Shanghai Ruijin Hospital
  • Clinical Hopital Center Zagreb
  • Clinical Hospital Dubrava
  • Clinicall Hospital "Merkur"
  • Nemocnice Boskovice s.r.o.
  • Faculty Hospital Brno
  • Univ. Hospital and Med. School Hradec Kralove
  • Onkologické Centrum J.G. Mendela
  • Fakultni Nemocnice Olomouc
  • Hospital Opava
  • Fakultni nemocnice Ostrava
  • Faculty Hospital Binohrady FNKV
  • Charles University Hospital
  • University Hospital Motol
  • RTO MN Usti n. Labem
  • North Estonian Regional Hospital
  • Tartu University Hospital
  • Queen Mary Hospital
  • Tuen Mun Hospital
  • Soroka Medical Centre
  • Rambam Medical Centre
  • Rabin Medical Centre
  • Kaplan Medical Centre
  • Riga Hematology Center
  • Clinical Centre Skopje
  • Hospital Ampang
  • Hospital University Kebangsaan Malaysia
  • ISSSTE Hospital Regional de Leon
  • Hospital Espanol de Mexico
  • Hospital General de Mexico
  • Instituto National de Cancerologia
  • Hospital Regional Monterrey, ISSTE
  • ISSSTEP Puebla
  • Hospital Carlso alberto seguin escobedo Arequipa
  • Hospital Alberto Sabogal sooguren Callao
  • Coltea Hospital
  • Coltea Hospital
  • University Emergency Center Bucharest
  • Clinic Judatean de Urgenta Brasov
  • Emergency County Clinical Hospital
  • Belgorod regional Clinical Hospital
  • Moscow Regional Clinical Research Institute
  • Botkin City Clinical Hospital
  • Novgorod Regional Clinical Hospital
  • Leningrad regional Cliniacal Hospital
  • SPB Pavlov State Medical University
  • Republican Clinic Oncology Dispensary
  • Clinical centre of Serbia
  • Clinical Centre Nis
  • Clinical Centre Novi Sad
  • Institute of Oncology Sremska Kamenica
  • National Cancer Institut Bratislava
  • OUSA Bratislava
  • Východoslovenský onkolgický ústav
  • Martinská fakultná nemocnima
  • Institut of Oncology Ljubljana
  • Hopelands Cancer Centre
  • Wilgers Oncology Centre
  • Falun Hospital
  • Sunderby Hospital
  • Sundsvall Hospital
  • Uddevalla Hospital
  • Kaohsiung Medical University Hospital
  • Taipei Veterans General Hospital
  • Taichung Veterans General Hospital
  • King Chulalongkorn Memorial Hospital
  • Phramongkutklao College of Medicine
  • Ramathibodi Hospital
  • Siriray Hospital
  • Chiang Mai University
  • Srinagarind Hospital
  • Songklanagrarind Hospital
  • Ankara University, School of Medicine
  • Osmangazi Univ. school of Medicine
  • Gaziantep University School of Medicine
  • Ericyes Univ. Med. School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

A

B

Arm Description

Treatment

Observation

Outcomes

Primary Outcome Measures

event free survival

Secondary Outcome Measures

progression free survival, overall survival and safety

Full Information

First Posted
November 16, 2006
Last Updated
May 25, 2016
Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00400478
Brief Title
A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13
Official Title
A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Aggressive B-cell Lymphoma: NHL-13
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, open label, phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL. Patients will be screened after successful standard induction therapy (CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm) will be recruited.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-Cell Lymphoma (DLBCL), Follicular NHL Grade 3b
Keywords
DLBCL, NHL 13, Rituximab, maintenance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
683 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Treatment
Arm Title
B
Arm Type
No Intervention
Arm Description
Observation
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Rituximab 375mg/m2 i every 8 weeks for two years (12 infusions)
Primary Outcome Measure Information:
Title
event free survival
Time Frame
4 years
Secondary Outcome Measure Information:
Title
progression free survival, overall survival and safety
Time Frame
four years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 4 to 8 cycles R-CHOP/like, total of 8x Rituximab CR, CRu ECOG/ 0.1 or 2 Known IPI at time of diagnosis Age > 18 years Negative pregnancy test Men must agree not to father a child during the therapy Exclusion Criteria: Transformed lymphoma Secondary malignancy Evidence of CNS - involvement Significant cardiac disease Creatinine > 2.0 mg/dl HIV, Hepatitis positive
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Jaeger, Prof. Dr.
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Border Medical Oncology
City
Wodonga
State/Province
Victoria
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
Country
Australia
Facility Name
Gosford Hospital
City
Gosford
Country
Australia
Facility Name
Greenslopes Hospital
City
Greenslopes
Country
Australia
Facility Name
Prince of Wales Hospital
City
Sidney
Country
Australia
Facility Name
Krankenhaus Oberpullendorf
City
Oberpullendorf
State/Province
Burgenland
ZIP/Postal Code
A-7350
Country
Austria
Facility Name
Krankenhaus Oberwart
City
Oberwart
State/Province
Burgenland
ZIP/Postal Code
A-7400
Country
Austria
Facility Name
A.ö. Krankenhaus der Landeshauptstadt St. Pölten
City
St. Poelten
State/Province
Niederoesterreich
ZIP/Postal Code
A-3100
Country
Austria
Facility Name
A.ö. Krankenhaus der Statutarstadt Wr. Neustadt
City
Wr. Neustadt
State/Province
Niederoesterreich
ZIP/Postal Code
A-2770
Country
Austria
Facility Name
Krankenhaus d. Barmherzigen Schwestern Linz
City
Linz
State/Province
Oberoesterreich
ZIP/Postal Code
A-4010
Country
Austria
Facility Name
Krankenhaus der Elisabethinen Linz
City
Linz
State/Province
Oberoesterreich
ZIP/Postal Code
A-4010
Country
Austria
Facility Name
KH Barmherzige Schwestern Ried
City
Ried
State/Province
Oberoesterreich
ZIP/Postal Code
A-4910
Country
Austria
Facility Name
Klinikum Kreuzschwestern Wels GmbH
City
Wels
State/Province
Oberösterreich
ZIP/Postal Code
A-4600
Country
Austria
Facility Name
A.ö. Landeskrankenhaus Steyr
City
Steyr
State/Province
Steiermark
ZIP/Postal Code
A-4400
Country
Austria
Facility Name
Bezirkskrankenhaus Kufstein
City
Endach
State/Province
Tirol
ZIP/Postal Code
A-6330
Country
Austria
Facility Name
A.oe.Bezirkskrankenhaus Hall
City
Hall
State/Province
Tirol
ZIP/Postal Code
A-6060
Country
Austria
Facility Name
Universitätsklinik Innsbruck/ Klinik für Innere Medizin
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Landeskrankenhaus Feldkirch
City
Feldkirch
State/Province
Vorarlberg
ZIP/Postal Code
A-6806
Country
Austria
Facility Name
LKH Bregenz
City
Bregenz
ZIP/Postal Code
A-6900
Country
Austria
Facility Name
KH Dornbirn
City
Dornbirn
ZIP/Postal Code
A-6850
Country
Austria
Facility Name
A.ö. Landeskrankenhaus Fürstenfeld
City
Fuerstenfeld
ZIP/Postal Code
A-8280
Country
Austria
Facility Name
Universitätsklinikum Graz
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
LKH Hohenems
City
Hohenems
ZIP/Postal Code
A-6845
Country
Austria
Facility Name
Universitaetsklinik Innsbruck
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Landeskrankenhaus Klagenfurt
City
Klagenfurt
ZIP/Postal Code
A-9020
Country
Austria
Facility Name
A.ö. Landeskrankenhaus Leoben
City
Leoben
ZIP/Postal Code
A-8700
Country
Austria
Facility Name
Krankenhaus der Stadt Linz
City
Linz
ZIP/Postal Code
A-4020
Country
Austria
Facility Name
LKH Weinviertel Mistelbach
City
Mistelbach
ZIP/Postal Code
A-2130
Country
Austria
Facility Name
St. Johanns LK
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
KH Barmherzige Brüder
City
Vienna
ZIP/Postal Code
A-1020
Country
Austria
Facility Name
Krankenhaus der Stadt Wien Rudolfsstiftung
City
Vienna
ZIP/Postal Code
A-1030
Country
Austria
Facility Name
AKH Wien / Hämatologie u. Hämostaseologie
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Kaiser-Franz-Josef-Spital
City
Vienna
ZIP/Postal Code
A-1100
Country
Austria
Facility Name
Krankenhaus der Stadt Wien Lainz
City
Vienna
ZIP/Postal Code
A-1130
Country
Austria
Facility Name
Hanusch-Krankenhaus
City
Vienna
ZIP/Postal Code
A-1140
Country
Austria
Facility Name
Wilhelminenspital
City
Vienna
ZIP/Postal Code
A-1160
Country
Austria
Facility Name
Sozialmedizinisches Zentrum Ost - Donauspital
City
Vienna
ZIP/Postal Code
A-1220
Country
Austria
Facility Name
LKH Villach
City
Villach
ZIP/Postal Code
A-9500
Country
Austria
Facility Name
LKH Vöcklabruck
City
Voecklabruck
ZIP/Postal Code
A-4840
Country
Austria
Facility Name
KH Waidhofen/Thaya
City
Waidhofen
ZIP/Postal Code
A-3830
Country
Austria
Facility Name
BKH Zams
City
Zams
ZIP/Postal Code
A-6511
Country
Austria
Facility Name
Clinical Centre University Sarajevo
City
Sarajevo
ZIP/Postal Code
71 000
Country
Bosnia and Herzegovina
Facility Name
University Center Tuzla
City
Tuzla
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina
Facility Name
Centro Goiano de Oncologia
City
Goiania
Country
Brazil
Facility Name
Hospital Santa Izabel
City
Salvador
Country
Brazil
Facility Name
Hospital das Clinicas FMUSP
City
Sao Paolo
Country
Brazil
Facility Name
Hospital deas Clinical FMUSP
City
Sao Paolo
Country
Brazil
Facility Name
UMHAT "St. George" Plodviv
City
Plovdiv
Country
Bulgaria
Facility Name
Nat. Centre of Hematology and Transfusiology Sofia
City
Sofia
Country
Bulgaria
Facility Name
MHAT "St. Marina" Varna
City
Varna
Country
Bulgaria
Facility Name
Chinese PLA General hospital
City
Bejing
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
Country
China
Facility Name
Harbin Institue
City
Harbin
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
Country
China
Facility Name
Changhai Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
Country
China
Facility Name
Clinical Hopital Center Zagreb
City
Zagreb
Country
Croatia
Facility Name
Clinical Hospital Dubrava
City
Zagreb
Country
Croatia
Facility Name
Clinicall Hospital "Merkur"
City
Zagreb
Country
Croatia
Facility Name
Nemocnice Boskovice s.r.o.
City
Boskovice
Country
Czech Republic
Facility Name
Faculty Hospital Brno
City
Brno
Country
Czech Republic
Facility Name
Univ. Hospital and Med. School Hradec Kralove
City
Kralove
Country
Czech Republic
Facility Name
Onkologické Centrum J.G. Mendela
City
Novi Jicin
Country
Czech Republic
Facility Name
Fakultni Nemocnice Olomouc
City
Olomouc
Country
Czech Republic
Facility Name
Hospital Opava
City
Opava
Country
Czech Republic
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava-Poruba
Country
Czech Republic
Facility Name
Faculty Hospital Binohrady FNKV
City
Prague
Country
Czech Republic
Facility Name
Charles University Hospital
City
Praha
Country
Czech Republic
Facility Name
University Hospital Motol
City
Praha
Country
Czech Republic
Facility Name
RTO MN Usti n. Labem
City
Usti nad Labem
Country
Czech Republic
Facility Name
North Estonian Regional Hospital
City
Tallin
ZIP/Postal Code
12915
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
15014
Country
Estonia
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Tuen Mun Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Soroka Medical Centre
City
Beer Sheva
Country
Israel
Facility Name
Rambam Medical Centre
City
Haifa
Country
Israel
Facility Name
Rabin Medical Centre
City
Petah-Tikva
Country
Israel
Facility Name
Kaplan Medical Centre
City
Rehovot
Country
Israel
Facility Name
Riga Hematology Center
City
Riga
Country
Latvia
Facility Name
Clinical Centre Skopje
City
Skopje
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Hospital Ampang
City
Ampang
Country
Malaysia
Facility Name
Hospital University Kebangsaan Malaysia
City
Kuala Lumpur
Country
Malaysia
Facility Name
ISSSTE Hospital Regional de Leon
City
Leon
Country
Mexico
Facility Name
Hospital Espanol de Mexico
City
Mexico City
Country
Mexico
Facility Name
Hospital General de Mexico
City
Mexico City
Country
Mexico
Facility Name
Instituto National de Cancerologia
City
Mexico City
Country
Mexico
Facility Name
Hospital Regional Monterrey, ISSTE
City
Monterrey
Country
Mexico
Facility Name
ISSSTEP Puebla
City
Puebla
Country
Mexico
Facility Name
Hospital Carlso alberto seguin escobedo Arequipa
City
Arequipa
Country
Peru
Facility Name
Hospital Alberto Sabogal sooguren Callao
City
Callao
Country
Peru
Facility Name
Coltea Hospital
City
Bucharest
ZIP/Postal Code
22328
Country
Romania
Facility Name
Coltea Hospital
City
Bucharest
Country
Romania
Facility Name
University Emergency Center Bucharest
City
Bucharest
Country
Romania
Facility Name
Clinic Judatean de Urgenta Brasov
City
Targu Mures
Country
Romania
Facility Name
Emergency County Clinical Hospital
City
Targu Mures
Country
Romania
Facility Name
Belgorod regional Clinical Hospital
City
Belgorod
ZIP/Postal Code
308007
Country
Russian Federation
Facility Name
Moscow Regional Clinical Research Institute
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Botkin City Clinical Hospital
City
Moscow
ZIP/Postal Code
125101
Country
Russian Federation
Facility Name
Novgorod Regional Clinical Hospital
City
Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Leningrad regional Cliniacal Hospital
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
SPB Pavlov State Medical University
City
St. Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
Republican Clinic Oncology Dispensary
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Clinical centre of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Centre Nis
City
NIs
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Clinical Centre Novi Sad
City
Novisad
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute of Oncology Sremska Kamenica
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
National Cancer Institut Bratislava
City
Bratislava
Country
Slovakia
Facility Name
OUSA Bratislava
City
Bratislava
Country
Slovakia
Facility Name
Východoslovenský onkolgický ústav
City
Kosice
Country
Slovakia
Facility Name
Martinská fakultná nemocnima
City
Martin
Country
Slovakia
Facility Name
Institut of Oncology Ljubljana
City
Ljubljana
ZIP/Postal Code
1100
Country
Slovenia
Facility Name
Hopelands Cancer Centre
City
Pietremarizburg
Country
South Africa
Facility Name
Wilgers Oncology Centre
City
Pretoria
Country
South Africa
Facility Name
Falun Hospital
City
Falun
ZIP/Postal Code
79182
Country
Sweden
Facility Name
Sunderby Hospital
City
Lulea
ZIP/Postal Code
97180
Country
Sweden
Facility Name
Sundsvall Hospital
City
Sundsvall
ZIP/Postal Code
85186
Country
Sweden
Facility Name
Uddevalla Hospital
City
Uddevalla
ZIP/Postal Code
45180
Country
Sweden
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
Country
Thailand
Facility Name
Phramongkutklao College of Medicine
City
Bangkok
Country
Thailand
Facility Name
Ramathibodi Hospital
City
Bangkok
Country
Thailand
Facility Name
Siriray Hospital
City
Bangkok
Country
Thailand
Facility Name
Chiang Mai University
City
Chiang Mai
Country
Thailand
Facility Name
Srinagarind Hospital
City
Khon kaen
Country
Thailand
Facility Name
Songklanagrarind Hospital
City
Songkla
Country
Thailand
Facility Name
Ankara University, School of Medicine
City
Ankara
ZIP/Postal Code
06620
Country
Turkey
Facility Name
Osmangazi Univ. school of Medicine
City
Eskisehir
ZIP/Postal Code
26480
Country
Turkey
Facility Name
Gaziantep University School of Medicine
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Facility Name
Ericyes Univ. Med. School
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
25911553
Citation
Jaeger U, Trneny M, Melzer H, Praxmarer M, Nawarawong W, Ben Yehuda D, Goldstein D, Mihaljevic B, Ilhan O, Ballova V, Hedenus M, Hsiao LT, Au WY, Burgstaller S, Weidinger G, Keil F, Dittrich C, Skrabs C, Klingler A, Chott A, Fridrik MA, Greil R; AGMT-NHL13 Investigators. Rituximab maintenance for patients with aggressive B-cell lymphoma in first remission: results of the randomized NHL13 trial. Haematologica. 2015 Jul;100(7):955-63. doi: 10.3324/haematol.2015.125344. Epub 2015 Apr 24.
Results Reference
result
PubMed Identifier
26521299
Citation
Jaeger U, Praxmarer M, Greil R; AGMT-NHL13 investigators. Response to comment by P. Vassilakopoulos and colleagues. Haematologica. 2015 Nov;100(11):e482. doi: 10.3324/haematol.2015.134288. No abstract available.
Results Reference
result
Links:
URL
http://www.agmt.at
Description
AGMT
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicaltrialsregister.eu/ctr-search/search;jsessionid=cJHnlkSBP30JjfQV2K-KXCK3mdjOE64o0FAsUcmzHmslzlaX5yhQ!675812678

Learn more about this trial

A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13

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