HD21

2024-518022-33-00 Protocol Uni-Koeln-1762 Therapeutic confirmatory (Phase III) Ended

Start 15 Jul 2016 · End 2 Dec 2024 · Status Ended · 6 EU/EEA countries · 166 sites · Protocol Uni-Koeln-1762

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ended
Participants planned 1,585
Countries 6
Sites 166

Advanced Stage of Hodgkin Lymphoma

Primary objective of the trial is to demonstrate reduced toxicity of the BrECADD treatment compared to escalated BEACOPP treatment measured by treatment-related morbidity (TRMB). Co-primary objective is to further demonstrate non-inferior efficacy of 6 cycles BrECADD compared to 6 cycles of escalated BEACOPP, each foll…

Key facts

Sponsor
University Of Cologne
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
15 Jul 2016 → 2 Dec 2024
Decision date (initial)
2024-11-19
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Millenium Pharmaceuticals, Inc.

External identifiers

EU CT number
2024-518022-33-00
EudraCT number
2014-005130-55
ClinicalTrials.gov
NCT02661503

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Primary objective of the trial is to demonstrate reduced toxicity of the BrECADD treatment compared to escalated BEACOPP treatment measured by treatment-related morbidity (TRMB). Co-primary objective is to further demonstrate non-inferior efficacy of 6 cycles BrECADD compared to 6 cycles of escalated BEACOPP, each followed by radiotherapy to PET-positive residual lesions, in terms of progression-free survival.

Secondary objectives 1

  1. To further explore efficacy, safety and feasibility of the regimen

Conditions and MedDRA coding

Advanced Stage of Hodgkin Lymphoma

VersionLevelCodeTermSystem organ class
20.0 HLGT 10025319 Lymphomas Hodgkin's disease 10029104

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. Histologically proven classical Hodgkin lymphoma
  2. First diagnosis, no previous treatment
  3. Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV
  4. Randomized main study: 18 to 60 years of age
  5. Cohort of older patients: 61 to 75 years of age

Exclusion criteria 6

  1. Composite lymphoma or nodular lymphocyte-predominat Hodgkin lymphoma
  2. Previous malignancy (exeptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1)
  3. Prior chemotherapy or radiotherapy (prephase is allowed as outlined in the protocol)
  4. Current disease which precludes protocol treatment
  5. Pregnancy, lactation
  6. Non-Compliance

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

  1. Randomized main study: Treatment-related morbidity (TRMB)
  2. Randomized main study: Progression-free survival (PFS)
  3. Cohort of older patients: Complete remission (CR) rate after chemotherapy

Secondary endpoints 12

  1. Randomized main study: Tumor response (CR rate)
  2. Randomized main study: Overall survival (OS)
  3. Randomized main study: Infertility rate at 1 year
  4. Randomized main study: Second malignancies
  5. Randomized main study: Quality of life (QoL)
  6. Randomized main study: Frequency of adverse events
  7. Randomized main study: Therapy adherence
  8. Randomized main study: Event-free Survival (EFS)
  9. Cohort of older Patients: TRMB
  10. Cohort of older patients: PFS
  11. Cohort of older patients: OS
  12. Cohort of older patients: Time to progression (PFSHL) and HL-specific survival (OSHL)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 11

Vincristine Sulfate

SUB05101MIG · Substance

Active substance
Vincristine Sulfate
Pharmaceutical form
INJECTION
Route of administration
INTRAVENOUS BOLUS USE
Max daily dose
1.4 mg/m2 milligram(s)/sq. meter
Max total dose
8.4 mg/m2 milligram(s)/sq. meter
Max treatment duration
6 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Etoposide Phosphate

SUB13772MIG · Substance

Active substance
Etoposide Phosphate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
200 mg/m2 milligram(s)/sq. meter
Max total dose
3600 mg/m2 milligram(s)/sq. meter
Max treatment duration
18 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Procarbazine Hydrochloride

SUB15017MIG · Substance

Active substance
Procarbazine Hydrochloride
Pharmaceutical form
CAPSULE
Route of administration
ORAL USE
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
4200 mg/m2 milligram(s)/sq. meter
Max treatment duration
42 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Prednisone

SUB10020MIG · Substance

Active substance
Prednisone
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
40 mg/m2 milligram(s)/sq. meter
Max total dose
3360 mg/m2 milligram(s)/sq. meter
Max treatment duration
84 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Etoposide

SUB07337MIG · Substance

Active substance
Etoposide
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
250 mg/m2 milligram(s)/sq. meter
Max total dose
3000 mg/m2 milligram(s)/sq. meter
Max treatment duration
18 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cyclophosphamide Monohydrate

SUB16414MIG · Substance

Active substance
Cyclophosphamide Monohydrate
Pharmaceutical form
POWDER FOR SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
1250 mg/m2 milligram(s)/sq. meter
Max total dose
7500 mg/m2 milligram(s)/sq. meter
Max treatment duration
6 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dacarbazine

SUB06882MIG · Substance

Active substance
Dacarbazine
Pharmaceutical form
POWDER FOR SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
250 mg/m2 milligram(s)/sq. meter
Max total dose
3000 mg/m2 milligram(s)/sq. meter
Max treatment duration
12 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Doxorubicin Hydrochloride

SUB01827MIG · Substance

Active substance
Doxorubicin Hydrochloride
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
40 mg/m2 milligram(s)/sq. meter
Max total dose
240 mg/m2 milligram(s)/sq. meter
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

ADCETRIS 50 mg powder for concentrate for solution for infusion

PRD2487300 · Product

Active substance
Brentuximab Vedotin
Substance synonyms
Monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E, SGN 35, SGN-35
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
180 mg milligram(s)
Max total dose
1080 mg milligram(s)
Max treatment duration
6 Day(s)
Authorisation status
Authorised
ATC code
L01XC12 — -
Marketing authorisation
EU/1/12/794/001
MA holder
TAKEDA PHARMA A/S
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Bleomycin Sulfate

SUB00844MIG · Substance

Active substance
Bleomycin Sulfate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS BOLUS USE
Max daily dose
10 mg/m2 milligram(s)/sq. meter
Max total dose
60 mg/m2 milligram(s)/sq. meter
Max treatment duration
6 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dexamethasone

SUB07017MIG · Substance

Active substance
Dexamethasone
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
40 mg milligram(s)
Max total dose
960 mg milligram(s)
Max treatment duration
24 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Of Cologne

22 Total trials 7 Recruiting 9 Ended
Academic / Non-commercial
Sponsor organisation
University Of Cologne
Address
Albertus-Magnus-Platz 1
City
Cologne
Postcode
50923
Country
Germany

Scientific contact point

Organisation
University Of Cologne
Contact name
Peter Borchmann

Public contact point

Organisation
University Of Cologne
Contact name
Peter Borchmann

Third parties 9

OrganisationCity, countryDuties
Amsterdam UMC Stichting
ORG-100008355
 Amsterdam, Netherlands Code 12, Code 5
Arbeitsgemeinschaft Medikamentoese Tumortherapie gGmbH
ORG-100010741
 Vienna, Austria Code 12, Code 5
Region Midtjylland
ORG-100009397
 Aarhus N, Denmark Code 12, Code 5
Icon Clinical Research Limited
ORG-100008322
 Dublin 18, Ireland Laboratory analysis
Uppsala University Hospital
ORG-100006249
 Uppsala, Sweden Code 12, Code 5
Labcorp Early Development Laboratories Inc.
ORG-100012865
 Chantilly, United States Laboratory analysis
Oslo University Hospital HF
ORG-100021349
 Oslo, Norway Code 12, Code 5
aCROmion GmbH
ORG-100031978
 Frechen, Germany On site monitoring, E-data capture
Almac Clinical Services (Ireland) Limited
ORG-100033336
 Dundalk, Ireland Code 14

Locations

6 EU/EEA countries · 166 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ended 93 10
Denmark Ended 22 2
Germany Ended 1,125 141
Netherlands Ended 36 6
Norway Ended 28 3
Sweden Ended 16 4
Rest of world
Australia, New Zealand, Switzerland
 — 265 —

Investigational sites

Austria

10 sites · Ended
SCRI CCCIT Ges.m.b.H.
Innere Medizin III, Muellner Hauptstrasse 48, 5020, Salzburg
Ordensklinikum Linz GmbH
Interne I: Internistische Onkologie, Hämatologie und Gastroenterologie, Seilerstaette 4, 4010, Linz
Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken
Klinische Abteilung für Hämatologie und Hämostaseologie, Waehringer Guertel 18-20, Alsergrund, Vienna
Medizinische Universitaet Innsbruck
Studienambulanz Hämatologie und Onkologie, Anichstrasse 35, 6020, Innsbruck
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
Med.Dept. III, Pavilion 6, Heinrich-Collin-Strasse 30, Penzing, Vienna
Ordensklinikum Linz GmbH
1. Internen Abteilung - Hämatologie mit Stammzelltransplantation, Fadingerstrasse 1, 4020, Linz
Steiermaerkische Krankenanstalten Ges.m.b.H.
Department für Hämato-Onkologie, Vordernberger Strasse 42, 8700, Leoben
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Interne E at LHK Rankwell, Carinagasse 47, 6800, Feldkirch
Oberoesterreichische Gesundheitsholding GmbH
Innere Medizin II, Onkologie, Gastroenterologie, Angiologie, Sierninger Strasse 170, 4400, Steyr
Kepler Universitaetsklinikum GmbH
Med Campus III., Krankenhausstrasse 9, 4020, Linz

Denmark

2 sites · Ended
Region Midtjylland
Department of Haematology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Odense University Hospital
Department of Haematology, HFE, J B Winsloews Vej 4, 5000, Odense C

Germany

141 sites · Ended
Klinikum Aschaffenburg-Alzenau gGmbH
Med. Klinik IV + Klinik für Hämatologie und int. Onkologie, Am Hasenkopf 1, Innenstadt, Aschaffenburg
Universitaetsklinikum Aachen AöR
Medizinische Klinik IV, Pauwelsstrasse 30, 52074, Aachen
St. Bernward Krankenhaus GmbH
MVZ Onkologie, Treibestrasse 9, Mitte, Hildesheim
Onkologisches Versorgungszentrum Friedrichshain Hämatologie, Onkologie und Palliativmedizin
Hämatologie, Onkologie und Palliativmedizin, Landsberger Allee 117, 10407, Berlin
Gemeinschaftspraxis Dr. med. Johannes Mohm, Dr. med. Gabriele Prange-Krex
Innere Medizin und Hämatologie und Onkologie, Canalettostraße 10, 01307, Dresden
Gemeinschaftspraxis Dr Med Regina Moeller Dr Med Tabea Appel Anett Krziwanie
Innere Medizin, Mauerstr.5, 06110, Halle
Gemeinschaftspraxis für Hämatologie und Onkologie Lebach
Innere Medizin, Friedenstrasse 2, 66822, Lebach
Wilhelm-Anton-Hospital Goch
Hämatologie/Onkologie, Voßheider Straße 214 - 232, 47574, Goch
Schwerpunktpraxis für Hämatologie und Onkologie
Hämatologie und Onkologie, Otto von Guericke Strasse 110, 39104, Magdeburg
Gemeinsschaftspraxis Dr. med. Dirk Tummes, Dr. med. Dorothee Guggenberger, Dr. med Andreas Lang
Hämatologie, Weberstrasse 8, 52064, Aachen
Staedtisches Klinikum Dessau
Haematologie/ Onkologie, Auenweg 38, Alten, Dessau-Rosslau
Vivantes Netzwerk fuer Gesundheit GmbH
Klinik für Innere Medizin, Haematologie und Onkologie, Rudower Strasse 48, Buckow, Berlin
DIAKO Ev. Diakonie-Krankenhaus gGmbH
Med. Klinik Abt. Haematologie / Onkologie, Groepelinger Heerstrasse 406-408, Ohlenhof, Bremen
Universitaetsmedizin Goettingen
Haematologie und Onkologie, Robert-Koch-Strasse 40, Weende, Goettingen
MVZ Onkologische Kooperation Harz GbR
Haematologie und internistische Onkologie, Koesliner Strasse 14, Juergenohl, Goslar
Westpfalz-Klinikum GmbH
Innere Medizin I / Haematologie, Hellmut-Hartert-Strasse 1, Innenstadt, Kaiserslautern
Universitaetsklinikum Jena KöR
Haematologie u. Internistische Onkologie, Erlanger Allee 101, Lobeda, Jena
Gemeinschaftspraxis Haematologie Onkologie
Onkologie, Arnoldstrasse 18, Johannstadt-Nord, Dresden
Klinikum Darmstadt GmbH
Medizinische Klinik V / Haematologie, Grafenstrasse 9, 64283, Darmstadt
Onkozentrum Dresden Freiberg Meissen
Innere Medizin, Leipziger Strasse 118, Pieschen-Sued, Dresden
Universitaetsklinikum Erlangen AöR
Medizinische Klinik V, Ulmenweg 18, Innenstadt, Erlangen
Technische Universitaet Dresden
Medizinische Klinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Muenster AöR
Innere Medizin A, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Johannes Wesling Klinikum Minden
Haematologie / Onkologie, Hans-Nolte-Strasse 1, Haeverstaedt, Minden
Universitaetsklinikum Tuebingen AöR
GCP-Studienzentrale der Innere Medizin II, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden GmbH
Innere Medizin III, Haematologie / Onkologie, Ludwig-Erhard-Strasse 100, Dotzheim, Wiesbaden
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Haematologie, III. Medizinische Klinik, Langenbeckstrasse 1, Oberstadt, Mainz
Universitaetsklinikum Magdeburg AöR
Klinik für Haematologie / Onkologie, Leipziger Strasse 44, 39120, Magdeburg
Universitaetsklinikum Ulm AöR
Innere Abteilung III, Albert-Einstein-Allee 23, Eselsberg, Ulm
Haematologie und Onkologie Muenchen-Pasing MVZ GmbH
Innere Medizin, Baeckerstrasse 4, Pasing-Obermenzing, Munich
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts
Zentrum für Innere Medizin, Wetzgauer Strasse 85, 73557, Mutlangen
Kliniken Maria Hilf GmbH Moenchengladbach
Medizinische Klinik I, Viersener Strasse 450, Windberg, Moenchengladbach
Klinikum Hanau GmbH
Medizinische Klinik III, Leimenstrasse 20, 63450, Hanau
University Medical Center Hamburg-Eppendorf
Onkologisches Zentrum, Abt. Haematologie / Onkologie, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Haematologie und Onkologie, Ratzeburger Allee 160, 23538, Luebeck
Onkologische Schwerpunktpraxis
Onkologie, Teutoburger Strasse 60, 33604, Bielefeld
Onkologische Schwerpunkpraxis Kurfürstendamm
Innere Medizin, Kurfürstendamm 65, 10707, Berlin
Gemeinschaftspraxis - Dr. Slawik/ Dr. Plath
Innere Medizin, Franziskanergasse 14, 86152, Augsburg
Johanniter GmbH
Innere Medizin I, Johanniterstrasse 3-5, Zentrum, Bonn
Staedtisches Klinikum Braunschweig gGmbH
Medizinische Klinik III, Celler Strasse 38, 38114, Brunswick
Klinikum Chemnitz gGmbH
Klinik für Innere Medizin III / Studiensekretariat, Flemmingstrasse 2, Altendorf, Chemnitz
Gesundheit Nord gGmbH Klinikverbund Bremen
Medizinische Klinik I, Abt. Haematologie/Onkologie, St.-Juergen-Strasse 1, Hulsberg, Bremen
Studienzentrum Onkologie Ravensburg GmbH
Innere Medizin, Elisabethenstrasse 19, 88212, Ravensburg
Universitaetsklinikum Regensburg AöR
Klinik und Poliklinik für Innere Medizin III, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Klinikum Mutterhaus der Borromaeerinnen gGmbH
Medizinische Klinik, Feldstrasse 16, Innenstadt, Trier
Vinzenz Von Paul Kliniken gGmbH
Marienhospital GmbH, Boeheimstrasse 37, Sued, Stuttgart
FEK Friedrich-Ebert-Krankenhaus Neumuenster GmbH
Haematologie, Onkologie, Nephrologie, Friesenstrasse 11, Innenstadt, Neumuenster
Pius-Hospital Oldenburg
Haematologie und Internistische Onkologie, Georgstrasse 12, Innenstadt, Oldenburg
Lahn-Dill-Kliniken GmbH
Onkologisches Zentrum - Haematologie/Onkologie, Forsthausstrasse 1-3, 35578, Wetzlar
Rheinland Klinikum Neuss GmbH
Medizinische Klinik II, Preussenstrasse 84, Stadionviertel, Neuss
Klinikum Oldenburg AöR
Innere Medizin & MVZ, Rahel-Straus-Strasse 10, Kreyenbrueck, Oldenburg
Universitaetsklinikum Wuerzburg AöR
Zentrum Innere Medizin, Med. Klinik und Poliklinik II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbH
Klinik für Haematologie / Onkologie, Husener Strasse 46, Kernstadt, Paderborn
Onkologisches Zentrum Wolfsburg-Helmstedt MVZ GmbH
Haematologie, Kaufhofpassage 5-7, Innenstadt, Wolfsburg
Universitaetsklinikum Bonn AöR
Medizinische Klinik III, Venusberg-Campus 1, Venusberg, Bonn
Charite Universitaetsmedizin Berlin KöR
Zentrum für Innere Medizin, Haematologie/Onkologie; Onkologische Portalambulanz (OPA), Chariteplatz 1, Mitte, Berlin
OncoResearch Lerchenfeld GmbH
Onkologischer Schwerpkt. Lerchenfeld, Lerchenfeld 14, Uhlenhorst, Hamburg
Albertinen-Krankenhaus/Albertinen-Haus gGmbH
Schwerpunkt Haematologie Onkologie Palliativmedizin, Suentelstrasse 11a, Schnelsen, Hamburg
Vincentius-Diakonissen-Kliniken gAG
Medizinische Klinik, Abt. II Haematologie / Onkologie, Suedendstrasse 32, Suedweststadt, Karlsruhe
Klinikverbund Allgaeu gGmbH
Innere Medizin III - Haematologie und Onkologie, Robert Weixler Strasse 50, 87439, Kempten (Allgau)
HELIOS Klinikum Krefeld GmbH
Medizinische Klinik II, Lutherplatz 40, Diessem/lehmheide, Krefeld
Gemeinschaftsklinikum Mittelrhein gGmbH
Innere Medizin, Johannes-Mueller-Strasse 7, Sued, Koblenz
Asklepios Klinik St George
Haematologische Abteilung, Lohmuehlenstrasse 5, St. Georg, Hamburg
Universitaetsmedizin Greifswald KöR
Innere Medizin C Abt. Haematologie / Onkologie, Ferdinand-Sauerbruch-Strasse, 17489, Greifswald
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Medizinische Klinik A, Bremserstrasse 79, Friesenheim, Ludwigshafen Am Rhein
Klinikum Ernst von Bergmann gGmbH
Haematologie/ Onkologie, Charlottenstrasse 72, Noerdliche Innenstadt, Potsdam
Onkopraxis Probstheida
Haematologie, Onkologie, Palliativmedizin, Struempellstrasse 42, Probstheida, Leipzig
Marien Gesellschaft Siegen gGmbH
Medizinische Klinik III Haematologie / Onkologie, Kampenstrasse 51, 57072, Siegen
Krankenhausgesellschaft St. Vincenz mbH
Haematologie, Auf Dem Schafsberg, 65549, Limburg
Rostock University Medical Center
Innere Medizin, Onkologie/ Haematologie, Ernst-Heydemann-Strasse 6, Hansaviertel, Rostock
Dr. Vehling-Kaiser MVZ GmbH
Haematologie und Onkologie, Achdorfer Weg 5, Achdorf, Landshut
Klinikum Lippe GmbH
Medizinische Klinik II, Rintelner Strasse 85, Luherheide, Lemgo
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik, Haematologie / Onkologie, Augustenburger Platz 1, Wedding, Berlin
Haematologie-Onkologie im Zentrum MVZ GmbH
Intern. Onkologie/Haematologie, Halderstrasse 29, Innenstadt, Augsburg
Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH
Medizinische Klinik, In Der Schornau 23-25, Langendreer, Bochum
Klinikum Bayreuth GmbH
Medizinische Klinik IV, Preuschwitzer Strasse 101, Roter Huegel, Bayreuth
Internistische Gemeinschaftspraxis - Dr. Zimber/ Dr. Brendel/ Dr. Hoesl/ Dr. Maintz
Innere Medizin, Weiltingerstraße 11, 90449, Nürnberg
Internistische Gemeinschaftspraxis - Dr. Burkhard / Dr. Reimann / Dr. Lorentz
Hämatologie/Onkologie, Wilhelm-Leuschner-Straße 11-13, 67547, Worms
Gemeinschaftspraxis für Hämatologie und Onkologie
Hämatologie/Onkologie, Steinfurter Strasse 60 b, 48149, Münster
Hämatologisch-Onkologische Schwerpunktpraxis - Dr. Forstbauer
Innere Medizin, Schloßstraße 18, 53840, Troisdorf
Charite Universitaetsmedizin Berlin KöR
Haematologie, Onkologie, Tumorimmunologie, Hindenburgdamm 30, Lichterfelde, Berlin
Vivantes MVZ GmbH
Klinik fuer Innere Medizin, Dieffenbachstrasse 1, Kreuzberg, Berlin
HELIOS Klinikum Berlin-Buch GmbH
Haematologie, Onkologie, Tumorimmunologie, Schwanebecker Chaussee 50, Buch, Berlin
Sozialstiftung Bamberg Medizinisches Versorgungszentrum am Bruderwald gGmbH
Onkologie/Haematologie Klinik, MVZ, Buger Strasse 80, Berg, Bamberg
HELIOS Klinikum Bad Saarow GmbH
Klinik fuer Haematologie, Onkologie und Palliativmedizin, Pieskower Strasse 33, 15526, Bad Saarow
Universitaetsklinikum Augsburg
Medizinische Klinik II, Stenglinstrasse 2, Kriegshaber, Augsburg
Klinikum Dortmund gGmbH
Medizinische Klinik / Onkologie, Beurhausstrasse 40, Mitte, Dortmund
Justus-Liebig-Universitaet Giessen
Medizinische Klinik IV, Haematologie / Onkologie, Klinikstrasse 33, 35392, Giessen
HOPA MVZ GmbH
Haematologisch-Onkologische Praxis Altona, Moerkenstrasse 47, Altona-Altstadt, Hamburg
Universitaet Leipzig
Medizinische Klinik II, Haematologie, Johannisallee 32a, Zentrum-Südost, Leipzig
MVZ III Onkologie der Evidia MVZ Halle (Saale)
Hämatologie/Onkologie, Niemeyerstraße 22, 06110, Halle
Malteser Norddeutschland gGmbH
Medizinische Klinik I, Waldstrasse 17, Westliche Hoehe, Flensburg
DIAKOVERE Krankenhaus gGmbH
MediProjekt, Marienstrasse 72-90, Suedstadt, Hanover
Praxis Fuer Interdisziplinaere Onkologie And Haematologie GbR
Innere Medizin/Onkologie, Wirthstrasse 11c, Landwasser, Freiburg Im Breisgau
Asklepios Kliniken Hamburg GmbH
Medizinische Klinik II, Paul-Ehrlich-Strasse 1, Othmarschen, Hamburg
Evangelisches Krankenhaus Hamm gGmbH
Medizinische Klinik, Hämatologie / Onkologie, Werler Strasse 110, Mitte, Hamm
Medical Center - University Of Freiburg
Innere Medizin I, Abteilung Hämatologie / Onkologie, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Klinikum Fulda gAG
Tumorklinik, MVZ Osthessen, Pacelliallee 4, Ziehers-Sued, Fulda
Mannheimer Onkologiepraxis - Dr. Plöger/ Dr. Schuster/ Dr. Brust
Innere Medizin, Q5, 14-22, Mannheim
Gemeinschaftspraxis - Dres. Verpoort, Wierecky und Brandl
Innere Medizin/, Hohe Weide 17 b, 20259, Hamburg
MVZ für Hämatologie und Onkologie der MVZ-Medizinisches Versorgungszentrum Mülheim GmbH
Hämatologie/Onkologie, Schulstraße 13, 45468, Mülheim an der Ruhr
Internistisches Facharztzentrum - Praxis für Hämatologie und Onkologie
Hämatologie/Onkologie, Bismarckstraße 23, 87700, Memmingen
KLINIKEN ESSEN SUED Evangelisches Krankenhaus Essen-Werden gGmbH
Haematologie, Pattbergstrasse 1-3, Werden, Essen
Universitaetsklinikum Essen AöR
Klinik für Haematologie / WTZ Ambulanz, Hufelandstrasse 55, Holsterhausen, Essen
St.-Antonius-Hospital gGmbH
Haematologie / Onkologie, Dechant-Deckers-Strasse 8, 52249, Eschweiler
Goethe University Frankfurt
Innere Medizin, Hämatologie, Onkologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Klinikum Esslingen GmbH
Innere Medizin, Hirschlandstrasse 97, Oberesslingen, Esslingen Am Neckar
Krankenhaus Nordwest GmbH
II. Medizinische Klinik, Steinbacher Hohl 2-26, Praunheim, Frankfurt Am Main
Universitaetsklinikum Schleswig-Holstein AöR
Campus Kiel, Karl-Lennert-Krebscentrum, Medizinische Klinik II, Arnold-Heller-Strasse 3, Brunswik, Kiel
Praxis für Hämatologie und Onkologie
Hämatologie/Onkologie, Europaallee 5, 66113, Saarbrücken
Universitaetsklinikum Duesseldorf AöR
Klinik für Haematologie, Onkologie und Klinische Immunologie, Moorenstrasse 5, Bilk, Duesseldorf
Staedtisches Klinikum Karlsruhe gGmbH
Medizinische Klinik III, Moltkestrasse 90, Weststadt, Karlsruhe
Klinikum Nuernberg
Klinik V Onkologie / Haematologie, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
Universitaetsklinikum Heidelberg AöR
Medizinische Klinik und Poliklinik V, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Institut Fuer Versorgungsforschung In Der Onkologie GbR
Praxisklinik für Haematologie und Onkologie, Neversstrasse 5, Sued, Koblenz
Philipps-Universitaet Marburg
Innere Medizin Haematologie / Onkologie, Baldingerstrasse, 35043, Marburg
Klinikum Idar-Oberstein GmbH
Innere Medizin I, Dr.-Ottmar-Kohler-Strasse 2, Idar, Idar-Oberstein
SLK-Kliniken Heilbronn GmbH
Klinik für Innere Medizin III, Am Gesundbrunnen 20-26, Neckargartach, Heilbronn
Klinikum der Universitaet Muenchen AöR
Med. Klinik III für Haematologie / Onkologie, Marchioninistrasse 15, Hadern, Munich
Klinikum rechts der Isar der TU Muenchen AöR
Medizinische Klinik III, Ismaninger Strasse 22, Au-Haidhausen, Munich
Universitaet Des Saarlandes
Innere Medizin I, Kirrberger Strasse 100, 66421, Homburg
Hospital Munich Schwabing
Haematologie, Onkologie, Immunologie, Koelner Platz 1, Schwabing-West, Munich
Medizinische Hochschule Hannover
Abteilung Haematologie / Onkologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
University Hospital Cologne AöR
Klinik I für Innere Medizin / Studienzentrum, Kerpener Strasse 62, Lindenthal, Cologne
Ortenau Klinikum
Medizinische Klinik II, Haematologie, Onkologie, Weingartenstrasse 70, Zell-Weierbach, Offenburg
Onkologische Schwerpunktpraxis Heidelberg
Onkologie, Kurfuersten-Anlage 34, Weststadt, Heidelberg
Klinikum Region Hannover GmbH
Haematologie und Onkologie, Stadionbruecke 4, Linden-Sued, Hanover
Kath. St. Paulus GmbH
Medizinische Klinik II, Onkologie, Johannesstrasse 9-17, Mitte, Dortmund
Gemeinschaftspraxis Hämatologie-Onkologie Gießen
Innere Medizin/Onkologie, Wingertshecke 6, 35392, Gießen
Medizinische Versorgungszentren am Städtischen Klinikum Braunschweig
Onkologie, Celler Straße 38, 38114, Braunschweig
Hämatologische Onkologische Praxis im Medicum
Innere Medizin, Schwachhauser Heerstraße 50, 28209, Bremen
Klinikum Sindelfingen-Böblingen gGmbH
Medizinische Klinik I und MVZ, Arthur-Gruber-Str. 70, 71065, Sindelfingen
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Klinik für Onkologie, Kriegsbergstrasse 60, Mitte, Stuttgart
Kliniken Suedostbayern AG
Medizinische Abteilung 5/3 Hämatologie, Cuno-Niggl-Strasse 3, 83278, Traunstein
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Klinik II für Innere Medizin, Klinikstrasse 11, Schilterhaeusle, Villingen-Schwenningen
Diakonie-Klinikum Stuttgart Diakonissenkrankenhaus und Paulinenhilfe gGmbH
Medizinische Klinik, Rosenbergstrasse 38, West, Stuttgart
Robert Bosch Krankenhaus GmbH
Innere Medizin III - Haematologie und Onkologie, Auerbachstrasse 110, Bad Cannstatt, Stuttgart
Barmherzige Brueder Trier gGmbH
I. Medizinische Abteilung, Nordallee 1, Trier-Nord, Trier
Helios Universitaetsklinikum Wuppertal
Medizinische Klinik I, Haematologie/Onkologie, Heusnerstrasse 40, Barmen, Wuppertal
Diakonie-Klinikum Schwaebisch Hall gGmbH
Innere Abteilung, Diakoniestrasse 10, 74523, Schwaebisch Hall
Klinik Dr. Hancken GmbH
Haematologie, Onkologie, Harsefelder Strasse 8, 21680, Stade

Netherlands

6 sites · Ended
Admiraal De Ruyter Ziekenhuis B.V.
Internal Medicine - Hematology, 'S-Gravenpolderseweg 114, 4462 RA, Goes
Meander Medisch Centrum
Internal Medicine - Hematology, Maatweg 3, 3813 TZ, Amersfoort
Jeroen Bosch Ziekenhuis Stichting
Internal Medicine/ Oncology-Hematology, Henri Dunantstraat 1, 5223 GZ, 'S-Hertogenbosch
Stichting OLVG
Hematology, Oosterpark 9, 1091 AC, Amsterdam
Leids Universitair Medisch Centrum (LUMC)
Hämataology, Albinusdreef 2, 2333 ZA, Leiden
Amsterdam UMC Stichting
Deptartment of Hematology, De Boelelaan 1117, 1081 HV, Amsterdam

Norway

3 sites · Ended
Oslo University Hospital HF
Avd. for kreftbehandling, Radiumhospitalet, Montebello, Ullernchausséen 70, Oslo
Helse Bergen HF
Department of Oncology and Medical Physics, Haukelandsveien 22, 5021, Bergen
St. Olavs Hospital HF
Cancer Clinic, Prinsesse Kristinas G. 3, 7030, Trondheim

Sweden

4 sites · Ended
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Research Unit Haematology and Coagulation, Bla Straket 5, Goteborgs Annedal, Goteborg
Region Vaesterbotten
Haematology Department, Koksvagen 11, Alidhem, Umea
Uppsala University Hospital
Oncology, Akademiska Sjukhuset, 751 85, Uppsala
Region Oestergoetland
Department of Haematology, Universitetssjukhuset I, 58185, Linkoping

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Austria 2017-04-13 2024-12-01
Denmark 2017-11-27 2024-12-01
Germany 2016-07-15 2024-12-01
Netherlands 2017-12-21 2024-12-01
Norway 2018-01-24 2024-12-01
Sweden 2018-10-04 2024-12-01

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
Summary of Results of this trial
SUM-106156
 2025-11-13T09:19:49 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
Summary of Results of this trial for a non-specialist-audience in English 2025-11-13T09:20:35 Submitted Laypersons Summary of Results
Summary of Results of this trial for a non-specialist-audience in German 2025-11-13T09:20:57 Submitted Laypersons Summary of Results
Summary of Results of this trial for a non-specialist-audience in Dutch 2025-11-13T09:22:32 Submitted Laypersons Summary of Results
Summary of Results of this trial for a non-specialist-audience in Norwegian 2025-11-13T09:22:56 Submitted Laypersons Summary of Results
Summary of Results of this trial for a non-specialist-audience in Danish 2025-11-21T13:52:44 Submitted Laypersons Summary of Results
Summary of Results of this trial for a non-specialist-audience in Swedish 2025-12-11T14:14:31 Submitted Laypersons Summary of Results

Documents 79 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Clinical study report (for publication) Clinical Study Report_2024-518022-33-00_for_publication 2
Laypersons summary of results (for publication) Summary of Results of this trial for a non-specialist-audience in Danish 1
Laypersons summary of results (for publication) Summary of Results of this trial for a non-specialist-audience in Dutch 1
Laypersons summary of results (for publication) Summary of Results of this trial for a non-specialist-audience in English 1
Laypersons summary of results (for publication) Summary of Results of this trial for a non-specialist-audience in German 1
Laypersons summary of results (for publication) Summary of Results of this trial for a non-specialist-audience in Norwegian 1
Laypersons summary of results (for publication) Summary of Results of this trial for a non-specialist-audience in Swedish 1
Protocol (for publication) D1_Protocol_2024-518022-33-00_redacted 10
Protocol (for publication) D1_Sub-Protocol 1_2024-518022-33-00_da-DK_redacted 1
Protocol (for publication) D1_Sub-Protocol 2_2024-518022-33-00_eng-DK_redacted 1
Protocol (for publication) D1_Sub-Protocol_2024-518022-33-00_eng-AT_redacted 8
Protocol (for publication) D1_Sub-Protocol_2024-518022-33-00_eng-NL 1
Protocol (for publication) D1_Sub-Protocol_2024-518022-33-00_eng-SE_redacted 1
Recruitment arrangements (for publication) FileNote_No Document upload 1
Recruitment arrangements (for publication) FileNote_No Document upload 1
Recruitment arrangements (for publication) FileNote_No Document upload 1
Recruitment arrangements (for publication) FileNote_No Document upload 1
Recruitment arrangements (for publication) FileNote_No Document upload 1
Recruitment arrangements (for publication) FileNote_No Document upload 1
Subject information and informed consent form (for publication) L1_SIS and ICF_additional info_de-DE 1
Subject information and informed consent form (for publication) L1_SIS and ICF_additional info_eng-DE 1
Subject information and informed consent form (for publication) L1_SIS and ICF_additional info_nl-NL_redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF_antibodies_de-DE 2
Subject information and informed consent form (for publication) L1_SIS and ICF_attachment side effects_de-DE 8
Subject information and informed consent form (for publication) L1_SIS and ICF_attachment side effects_eng-DE_redacted 8
Subject information and informed consent form (for publication) L1_SIS and ICF_attachment site effects_da-DK 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_core study AKH Wien_de-AT_redacted 5
Subject information and informed consent form (for publication) L1_SIS and ICF_core study BHS_Linz_de-AT_redacted 5
Subject information and informed consent form (for publication) L1_SIS and ICF_core study Elisabethinen_de-AT_redacted 5
Subject information and informed consent form (for publication) L1_SIS and ICF_core study Hanusch_de-AT_redacted 5
Subject information and informed consent form (for publication) L1_SIS and ICF_core study KUK_Linz_de-AT_redacted 5
Subject information and informed consent form (for publication) L1_SIS and ICF_core study LKH Feldkirch_de-AT_redacted 5
Subject information and informed consent form (for publication) L1_SIS and ICF_core study LKH Hochsteiermark_de-AT_redacted 5
Subject information and informed consent form (for publication) L1_SIS and ICF_core study PMU Salzburg_de-AT_redacted 5
Subject information and informed consent form (for publication) L1_SIS and ICF_core study Steyr_de-AT_redacted 5
Subject information and informed consent form (for publication) L1_SIS and ICF_core study UK Innsbruck_de-AT_redacted 5
Subject information and informed consent form (for publication) L1_SIS and ICF_core study_da-DK_redacted 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF_core study_de-DE_redacted 7
Subject information and informed consent form (for publication) L1_SIS and ICF_core study_eng-DE_redacted 7
Subject information and informed consent form (for publication) L1_SIS and ICF_core study_nl-NL_redacted 7
Subject information and informed consent form (for publication) L1_SIS and ICF_core study_nn-NO_redacted 5
Subject information and informed consent form (for publication) L1_SIS and ICF_core study_sv-SE_redacted 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF_elderly AKH Wien_de-AT_redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF_elderly BHS_Linz_de-AT_redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF_elderly Elisabethinen_de-AT_redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF_elderly Hanusch_de-AT_redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF_elderly KUK_Linz_de-AT_redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF_elderly LKH Feldkirch_de-AT_redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF_elderly LKH Hochsteiermark_de-AT_redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF_elderly PMU Salzburg_de-AT_redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF_elderly Steyr_de-AT_redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF_elderly UK Innsbruck_de-AT_redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF_elderly_de-DE_redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_elderly_eng-DE_redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_elderly_nl-NL_redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF_elderly_nn-NO_redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_elderly_sv-SE_redacted 5.0
Subject information and informed consent form (for publication) L1_SIS and ICF_extension follow up_de-DE 1
Subject information and informed consent form (for publication) L1_SIS and ICF_extension follow up_eng-DE 1
Subject information and informed consent form (for publication) L1_SIS and ICF_extension follow up_nl-NL_redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_kml data and samples_de-DE_redacted 1.0 & 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_QoL_de-DE 2
Subject information and informed consent form (for publication) L1_SIS and ICF_QoL_eng-DE 2
Subject information and informed consent form (for publication) L1_SIS and ICF_scientific substudies_de-DE 4
Subject information and informed consent form (for publication) L1_SIS and ICF_use remaining samples_de-DE 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Adcetris 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Adcetris_nSM 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Bleomycin 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Cyclophosphamide 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Darcarbazine 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Dexamethasone 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Doxorubicin 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Etoposide 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Etoposidephosphate 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Prednisone 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Procarbazine 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Vincristin 3
Summary of results (for publication) Summary of Results of this trial 1
Synopsis of the protocol (for publication) D1_FileNote_Protocol Synopsis_ENG_2024-518022-33-00 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-01 Germany Acceptable
2024-10-30
 2024-10-31

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