AzTrials
AzTrials

Mature B-cell Non-Hodgkin LymphomaPhase 3B-NHL 2013NCT03206671

Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents

A Phase 3 study testing Rituximab window, Additional doses of Rituximab and Cyclophosphamide in people with Mature B-cell Non-Hodgkin Lymphoma, run by University Hospital Muenster at 88 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The trial B-NHL 2013 is a collaborative prospective, multi-national, multi-center, randomized trial with participating centers of the NHL-BFM group (Austria, Switzerland, Czech Republic, Germany) and the Scandinavian NOPHO group (Denmark, Finland, Norway, Sweden). Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Mature B-cell Non-Hodgkin Lymphoma
What is being tested?
Rituximab window, Additional doses of Rituximab and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
650 participants
Where
88 sitesin 8 countries
Study dates
3 Aug 2017to Jun 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Newly diagnosed, histological or cytological and immunological proven aggressive mature B-cell Non-Hodgkin lymphoma including Burkitt lymphoma (BL), Burkitt leukemia (B-AL), diffuse large B-cell lymphoma (DLBCL), or mature B-cell NHL not further classified according to current WHO classification124. For rare subtypes (e.g. primary mediastinal large B-NHL, PMLBL, double hit lymphoma or high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements), consultation of the study center is recommended.
  • availability of slides/blocks for reference pathology and international pathology panel (except in cases with immunological and cytomorphological assurance of diagnosis)
  • age at diagnosis < 18 years
  • diagnostics and treatment in one of the participating centers of the trial
  • no previous chemotherapy, no previous lymphoma-directed treatment. No application of steroids for more than two days during the last month
  • adequate hepatic, renal and cardiac function, except if alteration is due to lymphoma infiltration. Please contact the study center in case of unclear cases.
Show all 11Show fewer
  • signed informed consent of patient and/or parents/guardians for treatment according to the protocol, participation and transfer of data
  • follow-up of at least two years after initial diagnosis is expected
  • Certificate of vaccination against hepatitis B or negative serology, defined as
  • evidence of immunization with HBs-antigen negative, anti-HBs positive and anti-HBc negative or
  • negative hepatitis B serology with HBs-antigen negative, anti-HBs and anti- HBc negative

Who cannot join

  • patients with insufficient work up not allowing a correct stratification into the risk groups
  • B-cell neoplasia as second malignancy
  • any other medical, psychiatric or social condition prohibiting treatment according to the protocol (e.g. previous malignancy, prior organ transplant, HIV infection or AIDS or severe immunodeficiency, etc.)
  • participation within a different trial for treatment of B-cell malignancies and/or concurrent treatment within any other clinical trial. Exceptions to this are the NHL-BFM Registry 2012 and trials with different endpoints, involving aspects of supportive treatment which can run parallel to B-NHL 2013 without influencing the outcome of this trial e.g. trials on antiemetics, antibiotics, strategies for psychosocial support etc.
  • overt hepatitis B or history of hepatitis B
  • hypersensitivity to rituximab or to murine proteins or to any of the other excipients of the Investigational Medicinal Product rituximab (MabThera®) or to ingredients of other IMPs.
  • lack of CD20 expression of the lymphoma cells
  • pregnancy and lactation

Trial locations and contacts

88 sites in 8 countries.

88 sites in 8 countries

Germany53 sites

  • Universitätsklinikum Aachen, Klinik für Kinder - und Jugendmedizin, Hämatologie / Onkologie

    Aachen, 52057

  • Klinikum Augsburg, Schwäbisches Kinderkrebszentrum, I. Klinik für Kinder und Jugendliche, Hämatologie / Onkologie

    Augsburg, 86156

  • Charité Campus Virchow-Klinikum, Zentrum für Kinder- und Jugendmedizin, Abt. Hämatologie / Onkologie

    Berg, 13353

  • HELIOS Klinikum Berlin-Buch, Kinderklinik, Pädiatrische Hämatologie und Onkologie

    Berlin, 13125

  • Evangelisches Krankenhaus Bielefeld GmbH, Klinik für Kinder- und Jugendmedizin, Hämatologie und Onkologie

    Bielefeld, 33617

  • Zentrum für Kinderheilkunde der Universität Bonn, Abt. Päd. Hämatologie / Onkologie

    Bonn, 53113

  • Städtisches Klinikum Braunschweig gGmbH, Klinik für Kinder- und Jugendmedizin, Station K5 / Päd. Hämato- und Onkologie

    Braunschweig, 38118

  • Klinikum Bremen-Mitte gGmbH, Prof.-Hess-Kinderklinik,Pädiatrische Onkologie und Hämatologie

    Bremen, 28177

  • Klinikum der Universität zu Köln, Klinik für Kinder- und Jugendmedizin, Abt. Kinderonkologie und -hämatologie

    Cologne, 50924

  • Carl-Thieme-Klinikum Cottbus gGmbH, Klinik für Kinder- und Jugendmedizin

    Cottbus, 03048

  • Vestische Kinderklinik, Universität Witten / Herdecke

    Datteln, 45711

  • Klinikum Dortmund gGmbH, Klinik für Kinder- und Jugendmedizin, Station K1, Abt. Päd. Onkologie / Hämatologie

    Dortmund, 44137

  • Universitätsklinik Carl Gustav Carus der TU Dresden, Klinik für Kinder- und Jugendmedizin

    Dresden, 01307

  • Universitätsklinikum Düsseldorf, Zentrum für Kinder- und Jugendmedizin, Klinik für Päd. Hämatologie und Onkologie

    Düsseldorf, 40225

  • HELIOS Klinikum Erfurt GmbH, Klinik für Kinder- und Jugendmedizin, Päd. Onkologie / Hämatologie

    Erfurt, 99089

  • Universitätsklinikum Erlangen, Klinik für Kinder- und Jugendmedizin, Pädiatrische Onkologie / Hämatologie

    Erlangen, 91054

  • Universitätsklinikum Essen, Zentrum für Kinder- und Jugendmedizin, Hämatologie / Onkologie

    Essen, 45122

  • Universitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie

    Frankfurt am Main, 60590

  • Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin, Klinik IV: Päd. Hämatologie und Onkologie

    Freiburg im Breisgau, 79106

  • Universitätsklinikum Gießen und Marburg, Standort Gießen, Zentrum für Kinderhämatologie und -onkologie

    Giessen, 35385

  • Georg-August-Universität Universitäts-Kinderklinik, Pädiatrie I

    Göttingen, 37075

  • Universitätsklinikum Greifswald KdöR, Klinik und Poliklinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Onkologie und Hämatologie

    Greifswald, 17475

  • Universitätsklinikum Halle (Saale), Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / Onkologie

    Halle, 06120

  • Universitätsklinikum Hamburg Eppendorf, Zentrum für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und Onkologie

    Hamburg, 20246

  • Medizinische Hochschule Hannover, Kinderheilkunde, Päd. Hämatologie / Onkologie

    Hanover, 30625

  • Universitäts-Kinderklinik Heidelberg, Abt. Hämatologie / Onkologie

    Heidelberg, 69120

  • Gemeinschaftskrankenhaus Herdecke, Kinder- und Jugendmedizin, Päd. Hämatologie / Onkologie

    Herdecke, 58313

  • Universitätskliniken für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie, Geb. 9

    Homburg, 66421

  • Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin

    Jena, 07745

  • Städtisches Klinikum Karlsruhe gGmbH, Kinderklinik, Station S 24

    Karlsruhe, 76133

  • Klinikum Kassel Gesundheit Nordhessen Holding AG, Klinik für pädiatrische Hämatologie und Onkologie

    Kassel, 34125

  • Universitätsklinikum Schleswig Holstein Campus Kiel, Klinik für Allgemeine Pädiatrie, Päd. Onkologie / Hämatologie

    Kiel, 24105

  • Gemeinschaftsklinikum Mittelrhein Kemperhof, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie

    Koblenz, 56073

  • HELIOS Klinikum Krefeld, Zentrum für Kinder- und Jugendmedizin, Päd. Hämatologie/Onkologie

    Krefeld, 47805

  • Universitätsklinikum Leipzig, Klinik für Kinder und Jugendliche, Abt. Päd. Hämatologie / Onkologie

    Leipzig, 04103

  • Universitätsklinikum Schleswig Holstein Campus Lübeck, Klinik für Kinder- und Jugendmedizin, Hämatologie und Onkologie

    Lübeck, 23538

  • Universitätsklinikum Magdeburg A. ö. R., Kinderklinik, Päd. Hämatologie / Onkologie

    Magdeburg, 39120

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Zentrum für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / Onkologie

    Mainz, 55101

  • Klinikum Mannheim gGmbH, Universitäts-Kinderklinik, Päd. Onkologie /Hämatologie

    Mannheim, 68167

  • Johannes Wesling Klinikum Minden, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie / Onkologie, Station E 22

    Minden, 32429

  • Klinikum der LMU, Dr. von Haunersches Kinderspital, Pädiatrische Hämatologie / Onkologie

    München, 80337

  • Klinikum Schwabing, Kinderklinik der TU Päd. Hämatologie / Onkologie, Station 24d

    München, 80804

  • Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und Onkologie

    Münster, 48149

  • Diakonie Neuendettelsau, Kliniken Hallerwiese / Cnopf'sche Kinderklinik, Pädiatrische Hämatologie /Onkologie

    Nuremberg, 90419

  • Klinikum Oldenburg AöR, Zentrum für Kinder- und Jugendmedizin, Abt. Hämatologie / Onkologie

    Oldenburg, 26133

  • Universitätsklinikum Regensburg, Klinik für Kinder- und Jugendmedizin, Abt. Päd. Hämatologie, Onkologie, SZT

    Regensburg, 93053

  • Universitätsklinikum Rostock, Kinder- und Jugendklinik, Päd. Hämatologie und Onkologie

    Rostock, 18057

  • Asklepios Klinik St. Augustin GmbH, Kinder- und Jugendmedizin, Kinder-Hämatologie und Onkologie

    Sankt Augustin, 53757

  • HELIOS Kliniken Schwerin GmbH, Klinik für Kinder- und Jugendmedizin, Station A1

    Schwerin, 19049

  • Klinikum Stuttgart, Olgahospital Zentrum für Kinder- und Jugendmedizin Pädiatrie 5 (Onkologie, Hämatologie, Immunologie)

    Stuttgart, 70174

  • Universitätsklinik Tübingen Klinik für Kinderheilkunde und Jugendmedizin, Päd. Hämatologie / Onkologie

    Tübingen, 72076

  • Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie

    Ulm, 89081

  • Universitätskinderklinik Würzburg, Päd. Onkologie und Hämatologie

    Würzburg, 97080

Other trials in Germany

Switzerland9 sites

  • Kantonsspital Aarau, Kinderklinik

    Aarau, 5001

  • Universitäts - Kinderspital beider Basel

    Basel, 4031

  • Ospedale San Giovanni, Reparto die Pediatria

    Bellinzona, 6500

  • Universitätsklinik für Kinderheilkunde, Pädiatrische Hämatologie/ Onkologie, Inselspital

    Bern, 3010

  • Hôpital des Enfants, Unité d'Oncologie Hématologie

    Geneva, 1211

  • Centre hospitalier universitaire vaudois, Unité d'hémato-oncologie pédiatrique

    Lausanne, 1011

  • Kinderspital Pädiatrische Hämatologie/ Onkologie

    Lucerne, 6000

  • Ostschweizer Kinderspital, Hämatologie/ Onkologie

    Sankt Gallen, 9006

  • Universitäts-Kinderspital, Pädiatrische Onkologie

    Zurich, 8032

Other trials in Switzerland

Austria6 sites

  • Univ.Klinik für Kinder- und Jugendheilkunde Graz, Klin. Abteilung für pädiatrische Hämato-Onkologie

    Graz, 8036

  • Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck, Universitätsklinik für Pädiatrie I

    Innsbruck, 6020

  • Klinikum Klagenfurt am Wörthersee, Abteilung für Kinder- und Jugendheilkunde

    Klagenfurt, 9020

  • Kepler Universitätsklinikum, Med Campus IV / Onkologie

    Linz, 4020

  • LKH Salzburg, Universitätsklinik für Kinder- und Jugendheilkunde, Kinderonkologie

    Salzburg, 5020

  • St. Anna Kinderspital

    Vienna, 1090

Other trials in Austria

Sweden6 sites

  • Sahlgrenska Universitetssjukhuset, Drottning Silvias Barn och Ungdomssjukhus, Barncancercentrum

    Gothenburg, 416 85

  • Universitetssjukhuset i Linköping, Barn och Ungdomsmedicinska kliniken, Barnonkologiska enheten

    Linköping, 581 85

  • Skåne Universitetssjukhus, Barnonkologi

    Lund, 221 85

  • Karolinska Universitetssjukhuset, Astrid Lindgrens Barnsjukhus, Barnonkologen

    Stockholm, 171 76

  • Universitetssjukhus Umeå, Barnonkologiska avdelningen, Barn 3 Norrlands

    Umeå, 901 85

  • Akademiska sjukhuset, Barnavdelningen för blod- och tumörsjukdomar

    Uppsala, 752 39

Other trials in Sweden

Finland5 sites

  • Helsinki University Hospital, Children´s Hospital, Dept of Pediatric Hematology and Oncology

    Helsinki, 00029 HUS

  • Kuopio University Hospital, Paediatric Haematology and Oncology

    Kuopio, 70029 KYS

  • University Hospital of Oulu, Paediatric Haematology and Oncology

    Oulu, 90029 OYS

  • Tampere University Hospital, Paediatric Haematology and Oncology

    Tampere, 33521

  • Turku University Hospital, Paediatric and Adolescent Haematology and Oncology

    Turku, 20521

Other trials in Finland

Denmark4 sites

  • Børneonkologisk afsnit 303B, Børneafdelingen, Aalborg Universitetshospital Nord

    Aalborg, 9000

  • Børn og Unge afsnit 4, Børneafdelingen, Aarhus Universitetshospital Skejby

    Aarhus, 8200 N

  • Børneonkologisk afsnit 5054, BørneUngeKlinikken, Juliane Marie Centret, Rigshospitalet

    Copenhagen, 2100 Ø

  • Børneonkologisk afsnit H2, H. C. Andersen Børnehospital, Odense Universitetshospital

    Odense, 5000 C

Other trials in Denmark

Norway4 sites

  • Haukeland University Hospital, National Study Center Norway

    Bergen, 5021

  • Oslo University Hospital, Rikshospitalet

    Oslo, 0424

  • University Hospital Northern Norway

    Tromsø, 9038

  • St Olavs Hospital

    Trondheim, 7006

Other trials in Norway

Czechia1 site

  • Department of Pediatric Hematology and Oncology, University Hospital Motol

    Prague, 150 06

Other trials in Czechia

About this study

Official title: B-NHL 2013 - Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents

The trial B-NHL 2013 is a collaborative prospective, multi-national, multi-center, randomized trial with participating centers of the NHL-BFM group (Austria, Switzerland, Czech Republic, Germany) and the Scandinavian NOPHO group (Denmark, Finland, Norway, Sweden). The aim of the trial is to evaluate the role of rituximab in the treatment of mature aggressive B-cell Non-Hodgkin lymphoma and leukemia (B-NHL and B-AL) in children and adolescents.

The following primary study questions are going to be analyzed:

Read more
  • the effectiveness (event-free survival) in pediatric patients with very limited mature B-NHL (R1 and R2 stage I and II) of substituting anthracyclines by the rituximab window without compromising survival rates.
  • the effectiveness (event-free survival) in pediatric patients with limited mature B-NHL (R2 stage III) randomly assigned to receive the rituximab window plus standard chemotherapy or standard chemotherapy without the rituximab window.
  • the effectiveness (event-free survival) and the immune reconstitution (recovery of CD19+ B-cells, IR) in pediatric patients with advanced mature B-NHL/B-AL (R3 and R4 incl. R4 CNS+) treated with BFM-type chemotherapy and randomly assigned schedules of one versus seven doses rituximab.

Secondary study questions will address

  • additional parameters for immune reconstitution, lymphocyte subpopulations, immunoglobulin levels, vaccination titers and infection rates
  • kinetics of immune reconstitution after treatment
  • adverse event and severe adverse event profile
  • inter-individual variability of rituximab response
  • role of different mechanisms of action of rituximab in advanced B-NHL/B-AL
Read the detailed description

Risk group stratification:

R1/R2 stage I+II:

  • R1: resection status: complete
  • R2: resection status: incomplete, stage I and II

R2 III:

  • R 2: resection status: incomplete, stage III and LDH < 2 x ULN (according to local reference value for adults)

R3/R4:

  • R3: resection status: incomplete, stage III and LDH ≥ 2 x ULN but < 4 x ULN or stage IV/B-AL and LDH < 4 x ULN and CNS negative
  • R4: resection status: incomplete, Stage III and LDH ≥ 4 x ULN or stage IV/B-AL and LDH ≥ 4 x ULN and CNS negative
  • R4 CNS +: stage IV/B-AL and CNS positive

For patients with very limited disease (R1/R2 stage I/II), the addition of rituximab might allow the omission of anthracyclines without jeopardizing survival rates but reducing acute and long term toxicities. In this treatment arm, it is tested whether the event-free survival is similar to that of the historical control when all patients receive one dose of rituximab as monotherapeutic agent in the rituximab window R five days prior to the start of standard chemotherapy as a substitute for anthracyclines.

For patients with limited disease (R2 stage III) it is tested whether the event-free survival can be improved by adding rituximab to the standard chemotherapy. Two different treatment regimens will be evaluated in a randomized design: Patients in the standard arm will receive the standard chemotherapy. Patients of the rituximab plus arm will receive one dose of rituximab as monotherapeutic agent in the rituximab window R five days prior to the start of standard chemotherapy.

For patients with advanced disease (R3/R4) it is tested whether the event-free survival can be improved by adding rituximab to the standard chemotherapy. Two different rituximab regimens will be evaluated in a randomized design: Patients in the standard arm will receive one dose of rituximab as monotherapeutic agent in the rituximab window R five days prior to the start of standard chemotherapy. Patients of the rituximab plus arm will receive the rituximab window and additional six doses of rituximab added to the first four courses of chemotherapy. In addition the immune reconstitution will be analyzed comparing the effect of the two regimens of rituximab added to standard chemotherapy.

Being tested
Rituximab window, Additional doses of Rituximab, Cyclophosphamide, Cytarabine, Dexamethasone

What participants receive

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

  • Rituximab windowDrug

    Rituximab window (375 mg/m²)

  • Additional doses of RituximabDrug

    2 doses of Rituximab (375 mg/m²) before the start of the first chemotherapy cycle, 2 doses of Rituximab before the start of the second chemotherapy cycle, 1 dose of rituximab before the start of the third chemotherapy cycle, 1 dose of Rituximab before the start of the forth chemotherapy cycle

  • CyclophosphamideDrug

    see detailed protocol description

  • CytarabineDrug

    see detailed protocol description

  • DexamethasoneDrug

    see detailed protocol description

  • Doxorubicin hydrochlorideDrug

    see detailed protocol description

  • Vindesine SulfateDrug

    see detailed protocol description

  • EtoposideDrug

    see detailed protocol description

  • IfosfamideDrug

    see detailed protocol description

  • MethotrexateDrug

    see detailed protocol description

  • PrednisoloneDrug

    see detailed protocol description

  • VincristineDrug

    see detailed protocol description

Study groups in NCT03206671
Study groupRoleWhat they receive
R1/R2 stage I+IIExperimentalRituximab window + standard chemotherapy without anthracyclines (Vincristine not in R1)
Receives: Drug: Rituximab window; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Etoposide; Drug: Ifosfamide; Drug: Methotrexate; Drug: Prednisolone; Drug: Vincristine
R2 stage III experimental armExperimentalRituximab window + Standard chemotherapy
Receives: Drug: Rituximab window; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Doxorubicin hydrochloride; Drug: Etoposide; Drug: Ifosfamide; Drug: Methotrexate; Drug: Prednisolone; Drug: Vincristine
R2 stage III standard armOtherStandard chemotherapy
Receives: Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Doxorubicin hydrochloride; Drug: Etoposide; Drug: Ifosfamide; Drug: Methotrexate; Drug: Prednisolone; Drug: Vincristine
R3/R4 rituximab plus armExperimentalRituximab window + standard chemotherapy plus six additional doses of rituximab
Receives: Drug: Rituximab window; Drug: Additional doses of Rituximab; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Doxorubicin hydrochloride; Drug: Vindesine Sulfate; Drug: Etoposide; Drug: Ifosfamide; Drug: Methotrexate; Drug: Prednisolone; Drug: Vincristine
R3/R4 standard armExperimentalRituximab window + standard chemotherapy
Receives: Drug: Rituximab window; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Doxorubicin hydrochloride; Drug: Vindesine Sulfate; Drug: Etoposide; Drug: Ifosfamide; Drug: Methotrexate; Drug: Prednisolone; Drug: Vincristine

What is being measured

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

  1. Event-free survival (EFS)

    EFS is defined as time from start of treatment/randomization up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease or relapse, treatment related death, death of any other cause or diagnosis of secondary malignancies.

    Measured: through study completion, maximal seven years

  2. Immune reconstitution rate (only in R3/R4 patients)

    Immune reconstitution rate is defined as percentage of patients achieving age adjusted normal B-cell counts (CD19 positive subpopulations) 12 months after start of treatment.

    Measured: 12 months after start of treatment

Secondary outcomes (13)

  1. Overall survival (OS)

    OS is defined as time from start of treatment/randomization up to death of any cause or to date of last contact for patients alive.

    Measured: through study completion, maximal seven years

  2. Relapse-free survival (RFS)

    RFS is defined as time from start of treatment/randomization up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease, or relapse.

    Measured: through study completion, maximal seven years

  3. Response rate (RR)

    Complete response, partial remission, objective effect, stable disease or progressive disease

    Measured: after rituximab window on day 5, after prephase (patients with rituximab window on day 10, patients without rituximab window on day 6) and after second course (on an average 5 to 6 weeks after start of treatment)

  4. Adverse event rate

    Rate of patients with acute toxicity defined as grade III/IV/V AE

    Measured: from the first day of protocol defined treatment until two years after start of protocol defined treatment

  5. Rate of patients achieving normal immunoglobulin level 12 months after start of treatment

    Measured: 12 months after start of treatment

  6. Time interval to normal immunoglobulin level

    Measured: through study completion, maximal seven years

  7. Time interval from start of treatment to normal CD19 positive B-cells in the peripheral blood.

    Measured: through study completion, maximal seven years

  8. Rate of patients with normal lymphocyte subpopulations in the peripheral blood 12 months after start of treatment

    Measured: 12 months after start of treatment

  9. Interval to normal lymphocyte subpopulations in the peripheral blood.

    Measured: through study completion, maximal seven years

  10. Rate of infections (defined by CTCAE V4) in the time interval from start of treatment until 24 months after start of treatment

    Measured: 24 months after start of treatment

  11. Rate of infections (defined by CTCAE V4) in the time interval from start of treatment until immune reconstitution (achievement of age adjusted normal B-cell counts)

    Measured: through study completion, maximal seven years

  12. Rate of patients with sufficient titers after vaccination one year after start of treatment

    Measured: 1 year after start of treatment

  13. Immune reconstitution rate (only in R1/R2 patients)

    Immune reconstitution rate is defined as percentage of patients achieving age adjusted normal B-cell counts (CD19 positive subpopulations) 12 months after start of treatment.

    Measured: 12 months after start of treatment

Timeline

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

  1. First posted2 Jul 2017
  2. Study start3 Aug 2017
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
650 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03206671
Sponsor's protocol ID
UKM12_0020
Other IDs
2013-003253-21
Acronym
B-NHL 2013
Status last verified
Apr 2026
First submitted
27 Jun 2017
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab window, Additional doses of Rituximab and Cyclophosphamide in people with Mature B-cell Non-Hodgkin Lymphoma, run by University Hospital Muenster at 88 sites in 8 countries.

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

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in Germany, Switzerland, Austria, Sweden, Finland and 3 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?

This study is still under way. Results are not available in the source record yet.

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

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

What does the primary outcome measure?

Event-free survival (EFS) (time frame: through study completion, maximal seven years). The study lists 2 primary outcomes in all. 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 NCT03206671.

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 30 Apr 2026.

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