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Rituximab and Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
rituximab
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
Sponsored by
German High-Grade Non-Hodgkin's Lymphoma Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, stage I grade 3 follicular lymphoma, contiguous stage II adult diffuse large cell lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult diffuse mixed cell lymphoma, nodal marginal zone B-cell lymphoma, anaplastic large cell lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, stage I adult immunoblastic large cell lymphoma, contiguous stage II adult Burkitt lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II adult Burkitt lymphoma, noncontiguous stage II mantle cell lymphoma, stage I adult Burkitt lymphoma, stage I mantle cell lymphoma, contiguous stage II marginal zone lymphoma, noncontiguous stage II marginal zone lymphoma, stage I marginal zone lymphoma, stage III marginal zone lymphoma, stage IV marginal zone lymphoma, stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage IV adult Burkitt lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV grade 3 follicular lymphoma, stage IV mantle cell lymphoma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma, including the following subtypes: Grade 3 follicular lymphoma Diffuse B-cell lymphoma, including diffuse large cell lymphoma with any of the following variants: Centroblastic Immunoblastic Plasmablastic Anaplastic large cell T-cell-rich B-cell lymphoma Primary effusion lymphoma Intravascular B-cell lymphoma Primary mediastinal B-cell lymphoma Burkitt's or Burkitt-like lymphoma Mantle cell lymphoma (blastoid) Aggressive marginal zone lymphoma (monocytoid) Previously untreated disease CD20-positive disease International Prognostic Index (IPI) score 0 No bulky disease Largest single or conglomerate tumor < 7.5 cm in diameter No mucosa-associated lymphoid tissue (MALT) lymphoma No CNS involvement of lymphoma (intracerebral, meningeal, or intraspinal) PATIENT CHARACTERISTICS: ECOG performance status 0-1 Platelet count ≥ 100,000/mm^3 WBC ≥ 2,500/mm^3 Lactate dehydrogenase normal Not pregnant or lactating Fertile patients must use effective contraception during and for 1 year after study participation Negative pregnancy test No known hypersensitivity to the study medications No known HIV-positivity No active hepatitis infection No impaired left ventricular function No severe cardiac arrhythmias No other impaired organ function No other serious disorder No other malignancy within the past 5 years except carcinoma in situ or basal cell skin cancer PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy No prior immunosuppressive treatment with cytostatics No planned radiotherapy to extranodal involvement No concurrent participation in other treatment studies

Sites / Locations

  • Haematologisch Onkologische Praxis
  • Klinikum Augsburg
  • Klinikum Bayreuth
  • Haematologisch-Onkologische Schwerpunktpraxis - Weilheim
  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
  • Franziskus Hospital
  • Augusta-Kranken-Anstalt gGmbH
  • Staedtisches Klinikum Braunschweig
  • DIAKO Ev. Diakonie Krankenhaus gGmbH
  • Hospital Kuchwald Chemnitz
  • Praxis Fuer Haematologie Internistische Onkologie
  • Medizinische Universitaetsklinik I at the University of Cologne
  • Carl - Thiem - Klinkum Cottbus
  • Praxis Dr. Rheinhold Siegmund - Dr. Matthias Penke
  • Klinikum Dortmund
  • Hans - Susemihl - Krankenhaus
  • St. Antonius Hospital
  • Universitaetsklinikum Essen
  • Klinikum Frankfurt (Oder) GmbH
  • Universitaetsklinikum Freiburg
  • Klinikum Fulda
  • Saint Josef Hospital
  • Universitaetsklinikum Goettingen
  • Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
  • Kreiskrankenhaus Gummersbach GMBH
  • St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
  • St. Sixtus Hospital
  • Asklepios Klinik St. Georg
  • University Medical Center Hamburg - Eppendorf
  • Haematologisch-Onkologische Praxis Altona
  • St. Marien-Hospital Hamm - Klinik Knappenstrasse
  • Evangelische Krankenhaus Hamm
  • Medizinische Hochschule Hannover
  • Ruprecht - Karls - Universitaet Heidelberg
  • St. Bernward Krankenhaus
  • Universitaetsklinikum des Saarlandes
  • Clinic for Bone Marrow Transplantation and Hematology and Oncology
  • Staedtisches Klinikum Karlsruhe gGmbH
  • St. Vincentius - Kliniken
  • Klinikum Kempten Oberallgaeu
  • University Hospital Schleswig-Holstein - Kiel Campus
  • Caritas - Krakenhaus Lebach
  • Klinikum Lippe - Lemgo
  • St. Vincenz Hospital Limburg
  • Klinikum der Stadt Ludwigshafen am Rhein
  • Kreiskrankenhaus Luedenscheid
  • Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
  • III Medizinische Klinik Mannheim
  • Universitaetsklinikum Giessen und Marburg GmbH - Marburg
  • Krankenhaus Ludmillenstift
  • Krankenhaus Maria Hilf GmbH
  • Haematologisch - Onkologische Gemeinschaftspraxis - Muenster
  • Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
  • Klinikum der Universitaet Muenchen - Grosshadern Campus
  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen
  • Klinikum Schwaebisch Gmuend Stauferklinik
  • Onkologische Schwerwpunktpraxis Dr. Ladda
  • Lukaskrankenhaus Neuss
  • Schlossbergkliniken Oberstaufen
  • Klinikum Oldenburg
  • Klinikum Ernst Von Bergmann
  • Prosper-Hospital Recklinghausen
  • St. Marien - Krankenhaus Siegen GMBH
  • Diakonie Klinikum Stuttgart
  • Krankenanstalt Mutterhaus der Borromaerinnen
  • Southwest German Cancer Center at Eberhard-Karls-University
  • Universitaetsklinikum Tuebingen
  • Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
  • St. Marienhospital - Vechta
  • Onkologische Schwerpunktpraxis
  • Dr. Horst-Schmidt-Kliniken
  • Helios Kliniken Wuppertal University Hospital
  • Rabin Medical Center - Beilinson Campus
  • Ospedale Civile - Piacenza
  • Arcispedale S. Maria Nuova
  • Cellulari ed Ematologia Sapienza

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Interventional: 6 R-CHOP-21

Interventional: 4 R-CHOP-21 + 2 x R

Arm Description

Arm I: Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo restaging of their disease. Patients with disease progression proceed to salvage therapy off study. All other patients receive 3 more courses of R-CHOP.

Arm II: Patients receive R-CHOP as in arm I. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo restaging of their disease. Patients with disease progression proceed to salvage therapy off study. All other patients receive 1 more course of R-CHOP followed by 2 courses of rituximab alone.

Outcomes

Primary Outcome Measures

Time to treatment failure (TTF) measured from day 1 of course 1 of Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (CHOP) therapy up to 3 years on study with life-long follow-up

Secondary Outcome Measures

Complete response (CR) rate duration until first relapse
Progression rate during treatment
Survival
Tumor control measured from day 1 of course 1 of CHOP therapy (non-tumor related events are censored)
Disease-free survival measured from day 1 of course 1 of CHOP therapy
Safety (adverse events, serious adverse events) assessed at 3 months after treatment

Full Information

First Posted
January 16, 2006
Last Updated
March 9, 2021
Sponsor
German High-Grade Non-Hodgkin's Lymphoma Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00278421
Brief Title
Rituximab and Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma
Official Title
Randomized Study Comparing 4 and 6 Cycles of Chemotherapy With CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) at 21-day Intervals, Both With 6 Cycles of Immunotherapy With the Monoclonal Anti-CD20-Positive B-Cell Lymphoma Aged 18-60 Years Having no Risk Factor (Age-Adjusted IPI=0) and No Large Tumor Mass (Diameter <7,5cm) [FLYER 6-6-6-4 Study]
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
German High-Grade Non-Hodgkin's Lymphoma Study Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. It is not yet known which schedule of rituximab and combination chemotherapy is more effective in treating non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and combination chemotherapy to compare how well they work in treating patients with aggressive B-cell non-Hodgkin's lymphoma.
Detailed Description
OBJECTIVES: Primary Compare the efficacy of 2 different schedules of immunochemotherapy comprising rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone in patients with previously untreated, low-risk, aggressive B-cell non-Hodgkin's lymphoma. Compare acute and chronic side effects in patients treated with these regimens. Compare time to treatment failure in patients treated with these regimens. Secondary Compare the time to progression in patients treated with these regimens. Compare the overall and disease-free/relapse-free survival of patients treated with these regimens. Compare the complete response rate in patients treated with these regimens. Compare the tumor control in patients treated with these regimens. Compare the safety of these regimens in these patients. Compare the pharmacoeconomics of these regimens. Compare patient adherence to these regimens. OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. All patients are given the option of receiving a 1-week course of pretreatment therapy comprising vincristine IV once on day -6 and oral prednisone once daily on days -6 to 0. Arm I: Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo restaging of their disease. Patients with disease progression proceed to salvage therapy off study. All other patients receive 3 more courses of R-CHOP. Arm II: Patients receive R-CHOP as in arm I. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo restaging of their disease. Patients with disease progression proceed to salvage therapy off study. All other patients receive 1 more course of R-CHOP followed by 2 courses of rituximab alone. All patients undergo final restaging after 6 courses of rituximab. Patients with disease progression, stable disease, or partial response proceed to salvage therapy off study. After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter. PROJECTED ACCRUAL: A total of 622 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, stage I grade 3 follicular lymphoma, contiguous stage II adult diffuse large cell lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult diffuse mixed cell lymphoma, nodal marginal zone B-cell lymphoma, anaplastic large cell lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, stage I adult immunoblastic large cell lymphoma, contiguous stage II adult Burkitt lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II adult Burkitt lymphoma, noncontiguous stage II mantle cell lymphoma, stage I adult Burkitt lymphoma, stage I mantle cell lymphoma, contiguous stage II marginal zone lymphoma, noncontiguous stage II marginal zone lymphoma, stage I marginal zone lymphoma, stage III marginal zone lymphoma, stage IV marginal zone lymphoma, stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage IV adult Burkitt lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV grade 3 follicular lymphoma, stage IV mantle cell lymphoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Interventional: 6 R-CHOP-21
Arm Type
Active Comparator
Arm Description
Arm I: Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo restaging of their disease. Patients with disease progression proceed to salvage therapy off study. All other patients receive 3 more courses of R-CHOP.
Arm Title
Interventional: 4 R-CHOP-21 + 2 x R
Arm Type
Active Comparator
Arm Description
Arm II: Patients receive R-CHOP as in arm I. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo restaging of their disease. Patients with disease progression proceed to salvage therapy off study. All other patients receive 1 more course of R-CHOP followed by 2 courses of rituximab alone.
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Primary Outcome Measure Information:
Title
Time to treatment failure (TTF) measured from day 1 of course 1 of Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (CHOP) therapy up to 3 years on study with life-long follow-up
Time Frame
through study completion
Secondary Outcome Measure Information:
Title
Complete response (CR) rate duration until first relapse
Time Frame
through study completion
Title
Progression rate during treatment
Time Frame
through study completion
Title
Survival
Time Frame
through study completion
Title
Tumor control measured from day 1 of course 1 of CHOP therapy (non-tumor related events are censored)
Time Frame
through study completion
Title
Disease-free survival measured from day 1 of course 1 of CHOP therapy
Time Frame
through study completion
Title
Safety (adverse events, serious adverse events) assessed at 3 months after treatment
Time Frame
through study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma, including the following subtypes: Grade 3 follicular lymphoma Diffuse B-cell lymphoma, including diffuse large cell lymphoma with any of the following variants: Centroblastic Immunoblastic Plasmablastic Anaplastic large cell T-cell-rich B-cell lymphoma Primary effusion lymphoma Intravascular B-cell lymphoma Primary mediastinal B-cell lymphoma Burkitt's or Burkitt-like lymphoma Mantle cell lymphoma (blastoid) Aggressive marginal zone lymphoma (monocytoid) Previously untreated disease CD20-positive disease International Prognostic Index (IPI) score 0 No bulky disease Largest single or conglomerate tumor < 7.5 cm in diameter No mucosa-associated lymphoid tissue (MALT) lymphoma No CNS involvement of lymphoma (intracerebral, meningeal, or intraspinal) PATIENT CHARACTERISTICS: ECOG performance status 0-1 Platelet count ≥ 100,000/mm^3 WBC ≥ 2,500/mm^3 Lactate dehydrogenase normal Not pregnant or lactating Fertile patients must use effective contraception during and for 1 year after study participation Negative pregnancy test No known hypersensitivity to the study medications No known HIV-positivity No active hepatitis infection No impaired left ventricular function No severe cardiac arrhythmias No other impaired organ function No other serious disorder No other malignancy within the past 5 years except carcinoma in situ or basal cell skin cancer PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy No prior immunosuppressive treatment with cytostatics No planned radiotherapy to extranodal involvement No concurrent participation in other treatment studies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael G.M. Pfreundschuh, MD †
Organizational Affiliation
Universitaetsklinikum des Saarlandes
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Viola Poeschel, MD
Organizational Affiliation
Study Office Homburg
Official's Role
Study Director
Facility Information:
Facility Name
Haematologisch Onkologische Praxis
City
Aachen
ZIP/Postal Code
52070
Country
Germany
Facility Name
Klinikum Augsburg
City
Augsburg
ZIP/Postal Code
DOH-86156
Country
Germany
Facility Name
Klinikum Bayreuth
City
Bayreuth
ZIP/Postal Code
D-95445
Country
Germany
Facility Name
Haematologisch-Onkologische Schwerpunktpraxis - Weilheim
City
Berlin
ZIP/Postal Code
13357
Country
Germany
Facility Name
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
D-12200
Country
Germany
Facility Name
Franziskus Hospital
City
Bielefeld
ZIP/Postal Code
D-33615
Country
Germany
Facility Name
Augusta-Kranken-Anstalt gGmbH
City
Bochum
ZIP/Postal Code
D-44791
Country
Germany
Facility Name
Staedtisches Klinikum Braunschweig
City
Braunschweig
ZIP/Postal Code
G-38114
Country
Germany
Facility Name
DIAKO Ev. Diakonie Krankenhaus gGmbH
City
Bremen
ZIP/Postal Code
D-28239
Country
Germany
Facility Name
Hospital Kuchwald Chemnitz
City
Chemnitz
ZIP/Postal Code
D-09113
Country
Germany
Facility Name
Praxis Fuer Haematologie Internistische Onkologie
City
Cologne
ZIP/Postal Code
D-50677
Country
Germany
Facility Name
Medizinische Universitaetsklinik I at the University of Cologne
City
Cologne
ZIP/Postal Code
D-50924
Country
Germany
Facility Name
Carl - Thiem - Klinkum Cottbus
City
Cottbus
ZIP/Postal Code
D-03048
Country
Germany
Facility Name
Praxis Dr. Rheinhold Siegmund - Dr. Matthias Penke
City
Damme
ZIP/Postal Code
D-49401
Country
Germany
Facility Name
Klinikum Dortmund
City
Dortmund
ZIP/Postal Code
D-44137
Country
Germany
Facility Name
Hans - Susemihl - Krankenhaus
City
Emden
ZIP/Postal Code
26721
Country
Germany
Facility Name
St. Antonius Hospital
City
Eschweiler
ZIP/Postal Code
DOH-52249
Country
Germany
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany
Facility Name
Klinikum Frankfurt (Oder) GmbH
City
Frankfurt (Oder)
ZIP/Postal Code
D-15236
Country
Germany
Facility Name
Universitaetsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
D-79106
Country
Germany
Facility Name
Klinikum Fulda
City
Fulda
ZIP/Postal Code
D-36013
Country
Germany
Facility Name
Saint Josef Hospital
City
Gelsenkirchen
ZIP/Postal Code
D-45899
Country
Germany
Facility Name
Universitaetsklinikum Goettingen
City
Goettingen
ZIP/Postal Code
D-37075
Country
Germany
Facility Name
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
City
Greifswald
ZIP/Postal Code
D-17475
Country
Germany
Facility Name
Kreiskrankenhaus Gummersbach GMBH
City
Gummersbach
ZIP/Postal Code
D-51643
Country
Germany
Facility Name
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
City
Hagen
ZIP/Postal Code
D-58095
Country
Germany
Facility Name
St. Sixtus Hospital
City
Haltern
ZIP/Postal Code
D-45721
Country
Germany
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
D-20099
Country
Germany
Facility Name
University Medical Center Hamburg - Eppendorf
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
Haematologisch-Onkologische Praxis Altona
City
Hamburg
ZIP/Postal Code
D-22767
Country
Germany
Facility Name
St. Marien-Hospital Hamm - Klinik Knappenstrasse
City
Hamm
ZIP/Postal Code
D-59071
Country
Germany
Facility Name
Evangelische Krankenhaus Hamm
City
Hamm
ZIP/Postal Code
DOH-59063
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
D-30625
Country
Germany
Facility Name
Ruprecht - Karls - Universitaet Heidelberg
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
St. Bernward Krankenhaus
City
Hildesheim
ZIP/Postal Code
D-31134
Country
Germany
Facility Name
Universitaetsklinikum des Saarlandes
City
Homburg
ZIP/Postal Code
D-66424
Country
Germany
Facility Name
Clinic for Bone Marrow Transplantation and Hematology and Oncology
City
Idar-Oberstein
ZIP/Postal Code
D-55743
Country
Germany
Facility Name
Staedtisches Klinikum Karlsruhe gGmbH
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
St. Vincentius - Kliniken
City
Karlsruhe
ZIP/Postal Code
D-76137
Country
Germany
Facility Name
Klinikum Kempten Oberallgaeu
City
Kempten
ZIP/Postal Code
D-87439
Country
Germany
Facility Name
University Hospital Schleswig-Holstein - Kiel Campus
City
Kiel
ZIP/Postal Code
D-24116
Country
Germany
Facility Name
Caritas - Krakenhaus Lebach
City
Lebach
ZIP/Postal Code
66822
Country
Germany
Facility Name
Klinikum Lippe - Lemgo
City
Lemgo
ZIP/Postal Code
D-32657
Country
Germany
Facility Name
St. Vincenz Hospital Limburg
City
Limburg
ZIP/Postal Code
D-65549
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen am Rhein
City
Ludwigshafen am Rhein
ZIP/Postal Code
D-67063
Country
Germany
Facility Name
Kreiskrankenhaus Luedenscheid
City
Luedenscheid
ZIP/Postal Code
58515
Country
Germany
Facility Name
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
City
Magdeburg
ZIP/Postal Code
D-39120
Country
Germany
Facility Name
III Medizinische Klinik Mannheim
City
Mannheim
ZIP/Postal Code
D-68305
Country
Germany
Facility Name
Universitaetsklinikum Giessen und Marburg GmbH - Marburg
City
Marburg
ZIP/Postal Code
D-35033
Country
Germany
Facility Name
Krankenhaus Ludmillenstift
City
Meppen
ZIP/Postal Code
49716
Country
Germany
Facility Name
Krankenhaus Maria Hilf GmbH
City
Moenchengladbach
ZIP/Postal Code
D-41063
Country
Germany
Facility Name
Haematologisch - Onkologische Gemeinschaftspraxis - Muenster
City
Muenster
ZIP/Postal Code
D-48149
Country
Germany
Facility Name
Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
D-48149
Country
Germany
Facility Name
Klinikum der Universitaet Muenchen - Grosshadern Campus
City
Munich
ZIP/Postal Code
D-81377
Country
Germany
Facility Name
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
City
Munich
ZIP/Postal Code
D-81675
Country
Germany
Facility Name
Klinikum Schwaebisch Gmuend Stauferklinik
City
Mutlangen
ZIP/Postal Code
D-73557
Country
Germany
Facility Name
Onkologische Schwerwpunktpraxis Dr. Ladda
City
Neumarkt
ZIP/Postal Code
D-92318
Country
Germany
Facility Name
Lukaskrankenhaus Neuss
City
Neuss
ZIP/Postal Code
D-41464
Country
Germany
Facility Name
Schlossbergkliniken Oberstaufen
City
Oberstaufen
ZIP/Postal Code
D-87534
Country
Germany
Facility Name
Klinikum Oldenburg
City
Oldenburg
ZIP/Postal Code
D-26133
Country
Germany
City
Pforzheim
ZIP/Postal Code
75179
Country
Germany
Facility Name
Klinikum Ernst Von Bergmann
City
Potsdam
ZIP/Postal Code
D-14467
Country
Germany
Facility Name
Prosper-Hospital Recklinghausen
City
Recklinghausen
ZIP/Postal Code
DOH-45659
Country
Germany
City
Rostock
ZIP/Postal Code
D-18257
Country
Germany
Facility Name
St. Marien - Krankenhaus Siegen GMBH
City
Siegen
ZIP/Postal Code
D-57072
Country
Germany
Facility Name
Diakonie Klinikum Stuttgart
City
Stuttgart
ZIP/Postal Code
D-70176
Country
Germany
Facility Name
Krankenanstalt Mutterhaus der Borromaerinnen
City
Trier
ZIP/Postal Code
D-54219
Country
Germany
Facility Name
Southwest German Cancer Center at Eberhard-Karls-University
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
D-89081
Country
Germany
Facility Name
St. Marienhospital - Vechta
City
Vechta
ZIP/Postal Code
D-49377
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis
City
Wendlingen
ZIP/Postal Code
73240
Country
Germany
Facility Name
Dr. Horst-Schmidt-Kliniken
City
Wiesbaden
ZIP/Postal Code
D-65199
Country
Germany
Facility Name
Helios Kliniken Wuppertal University Hospital
City
Wuppertal
ZIP/Postal Code
D-42283
Country
Germany
Facility Name
Rabin Medical Center - Beilinson Campus
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Ospedale Civile - Piacenza
City
Piacenza
ZIP/Postal Code
29100
Country
Italy
Facility Name
Arcispedale S. Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Cellulari ed Ematologia Sapienza
City
Roma
ZIP/Postal Code
00161
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
31868632
Citation
Poeschel V, Held G, Ziepert M, Witzens-Harig M, Holte H, Thurner L, Borchmann P, Viardot A, Soekler M, Keller U, Schmidt C, Truemper L, Mahlberg R, Marks R, Hoeffkes HG, Metzner B, Dierlamm J, Frickhofen N, Haenel M, Neubauer A, Kneba M, Merli F, Tucci A, de Nully Brown P, Federico M, Lengfelder E, di Rocco A, Trappe R, Rosenwald A, Berdel C, Maisenhoelder M, Shpilberg O, Amam J, Christofyllakis K, Hartmann F, Murawski N, Stilgenbauer S, Nickelsen M, Wulf G, Glass B, Schmitz N, Altmann B, Loeffler M, Pfreundschuh M; FLYER Trial Investigators; German Lymphoma Alliance. Four versus six cycles of CHOP chemotherapy in combination with six applications of rituximab in patients with aggressive B-cell lymphoma with favourable prognosis (FLYER): a randomised, phase 3, non-inferiority trial. Lancet. 2019 Dec 21;394(10216):2271-2281. doi: 10.1016/S0140-6736(19)33008-9.
Results Reference
derived

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Rituximab and Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma

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