Clinical trial • Phase III • Oncology

TAFASITAMAB for Diffuse large B-cell lymphoma (DLBCL)

Phase III trial of TAFASITAMAB for Diffuse large B-cell lymphoma (DLBCL).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Diffuse large B-cell lymphoma (DLBCL)
Trial Stage
Phase III
Drug Modality
Monoclonal antibody | Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
12-03-2024
First CTIS Authorization Date
19-04-2024

Trial design

Randomised, control arm: tafasitamab placebo plus lenalidomide placebo in addition to r-chop (r-chop administered per standard schedule; six 21-day cycles; eot defined as day 21 of the last treatment cycle). Phase III trial in France, Ireland, Austria and others.

Randomised
Yes
Comparator
Control arm: tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP (R-CHOP administered per standard schedule; six 21-day cycles; EOT defined as day 21 of the last treatment cycle).
Target Sample Size
880
Trial Duration For Participant
1951

Eligibility

Recruits 880 isVulnerablePopulationSelected is true in trial metadata. Only adults (18–80 years) are eligible and a signed written informed consent form (ICF) is required. ICFs and related subject information (including pregnancy-specific and genetic/genomic optional consent forms) are provided in multiple local languages. No procedures for assent of minors are provided (minors excluded)..

Pregnancy Exclusion
4m) Patients with pregnancy or lactation
Vulnerable Population
isVulnerablePopulationSelected is true in trial metadata. Only adults (18–80 years) are eligible and a signed written informed consent form (ICF) is required. ICFs and related subject information (including pregnancy-specific and genetic/genomic optional consent forms) are provided in multiple local languages. No procedures for assent of minors are provided (minors excluded).

Inclusion criteria

  • {"criterion_text":"- Signed written informed consent form (ICF).\n- Patient must have the following local laboratory criteria at screening: a. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (unless secondary to bone marrow involvement by DLBCL) b. Platelet count ≥ 75 x 10^9/L (unless secondary to bone marrow involvement by DLBCL) c. Total serum bilirubin < 1.5 × upper limit of normal (ULN) unless secondary to Gilbert’s Syndrome or documented liver involvement by lymphoma. Patients with Gilbert’s Syndrome or documented liver involvement by lymphoma may be included if their total bilirubin is ≤ 5 × ULN d. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤ 3 × ULN, or ≤ 5 × ULN in cases of documented liver involvement e. Serum creatinine clearance must be ≥ 30 mL/minute either measured or calculated using a standard Cockcroft and Gault formula (Cockroft and Gault, 1976)\n- In the opinion of investigator, the patient must: a. Be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events, e.g. aspirin 75 to 325 mg per os, orally (PO) daily (81 to 325 mg PO daily in the US) or low molecular weight heparin (e.g. enoxaparin 40 mg (4,000 IU) once daily by subcutaneous (SC) injection). This is due to increased risk of thrombosis in patients treated with lenalidomide without prophylaxis. Patients unable or unwilling to take any prophylaxis are not eligible b. Be able to understand, give written informed consent, and comply with all study-related procedures, medication use, and evaluations c. Not have a history of noncompliance in relation to medical regimens nor be considered potentially unreliable and/or uncooperative d. Be able to understand the reason for complying with the special conditions of the pregnancy prevention and in writing acknowledge to adhere to them\n- Due to the teratogenic potential of lenalidomide, females of childbearing potential (FCBP) must: a. Not be pregnant as confirmed by a negative serum pregnancy test at screening and a medically supervised urine pregnancy test prior to starting study therapy b. Refrain from breast feeding and donating oocytes during the course of study and for three (3) months after the last dose of study drug or according to local guidelines for R-CHOP, whichever is longer c. Agree to ongoing pregnancy testing during the course of the study and after study therapy has ended. Additionally, agree to pregnancy testing and counseling if a patient misses her period or if there is any abnormality in her menstrual bleeding. This applies even if the patient applies complete sexual abstinence d. Commit to continued abstinence from heterosexual intercourse if it is in accordance with her lifestyle (which must be reviewed on a monthly basis) or agree to use and be able to comply with the use of highly effective contraception without interruption at least four (4) weeks prior to start of study drugs, during the study treatment and for three (3) months after the last dose of study drug, or, for R-CHOP, according to the local guidelines, whichever is longer.\n- Male participants must: a. Use an effective barrier method of contraception without interruption if the patient is sexually active with a FCBP. Male participants should refrain from donating sperm during the study participation and for three (3) months after the last dose of study drug, or according to the local guidelines for R-CHOP, whichever is longer\n- Adult subjects aged 18 (or legal age per local regulations) to 80 years of age inclusive.\n- Previously untreated patients with local biopsy-proven, CD20-positive DLBCL, including one of the following diagnoses by 2016 World Health Organization (WHO) classification of lymphoid neoplasms are eligible: • DLBCL, NOS including GCB type, ABC type • T-cell rich large BCL • Epstein-Barr virus-positive DLBCL, NOS • Anaplastic lymphoma kinase (ALK)-positive large BCL • Human herpes virus-8 (HHV8)-positive DLBCL, NOS • High-grade BCL with MYC and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements (double-hit or triple-hit lymphoma). Please note: Patients must be appropriate candidates for R-CHOP. If an investigator deems a patient with a known double- or triple-hit lymphoma (HGBL) should be treated more aggressively (e.g. dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab [DA-EPOCH-R] or cyclophosphamide, vincristine, doxorubicin and dexamethasone (CVAD) followed by methotrexate and cytarabine [Hyper CVAD]), this patient would not be considered eligible for this study • HGBL-NOS • DLBCL coexistent with either FL of any grade, gastric mucosa-associated lymphoid tissue (MALT) lymphoma or non-gastric MALT lymphoma • FL Grade 3b\n- Availability of archival or freshly collected tumor tissue sent for retrospective central pathology review. Please note: Neither receipt of tumor samples nor central review of diagnosis is necessary prior to study enrollment.\n- Up to six (6) of the largest target nodes, nodal masses, or other lymphomatous lesions that are measurable in two (2) diameters should be identified by local assessment from different body regions representative of the patient’s overall disease burden and include mediastinal and retroperitoneal disease, if involved. At baseline, a measurable node must be greater than 15 mm in longest diameter (LDi). Measurable extranodal disease may be included in the six (6) representative, measured lesions. At baseline, measurable extranodal lesions should be greater than 10 mm LDi. All other lesions (including nodal, extranodal, and assessable disease) should be followed as nonmeasured disease as non-target lesions (e.g. cutaneous, GI, spleen, liver, kidneys, pleural or pericardial effusions, ascites, bone, bone marrow). Patients with ONLY bone lesions should be excluded. At least one (1) measurable lesion must be confirmed to be PET-positive (Deauville score of 4 or 5) at the time of randomization by local assessment.\n- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n- IPI status of 3 to 5 (for patients > 60 years of age) or aaIPI 2 to 3 (for patients ≤ 60 years of age).\n- Diagnosis to treatment interval, defined as the time between the date of DLBCL diagnosis (date of the first biopsy specimen containing B-cell lymphoma according to the local pathology report) and the start of treatment (cycle 1 study day 1 (C1D1)) ≤ 28 days.\n- Left ventricular ejection fraction ≥ 50% as assessed by local echocardiography or cardiac multi-gated acquisition (MUGA) scan."}

Exclusion criteria

  • {"criterion_text":"- 1) Any other histological type of lymphoma according to WHO 2016 classification of lymphoid neoplasms, e.g. primary mediastinal (thymic) large B-cell lymphoma, Burkitt’s lymphoma, BCL, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey-zone lymphoma); primary effusion lymphoma; primary cutaneous DLBCL, leg type; primary DLBCL of the CNS; DLBCL arising from CLL or indolent lymphoma.\n- 4g) Patients with history or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that, in the investigator’s opinion, would preclude participation in the study or compromise the patient’s ability to give informed consent\n- 4h) Patients with history or evidence of rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption\n- 4i) Patients with vaccination with live vaccine within 21 days prior to study randomization\n- 4j) Patients with major surgery within up to 21 days prior to signing the informed consent form (ICF), unless the patient is recovered at the time of signing the ICF\n- 4k) Patients with any systemic anti-lymphoma and/or investigational therapy prior to the start of C1D1, except for permitted pre-phase treatment\n- 4l) Patients with contraindication to any of the individual components of R-CHOP, including prior receipt of anthracyclines\n- 4m) Patients with pregnancy or lactation\n- 4n) Patients with history of hypersensitivity to any component of R-CHOP, to lenalidomide, to compounds of similar biological or chemical composition to tafasitamab, IMiDs and/or the excipients contained in the study drug formulations\n- 2) History of radiation therapy to ≥ 25% of the bone marrow for other diseases.\n- 3) History of prior non-hematologic malignancy except for the following: a. Malignancy treated with curative intent and with no evidence of active disease present for more than two (2) years before screening b. Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer. c. Adequately treated carcinoma in situ without current evidence of disease.\n- 4a) Patients with positive local test result during screening for hepatitis C (hepatitis C virus [HCV] antibody serology testing) and a positive test for HCV RNA. Patients with positive serology must have been tested locally for HCV RNA and are eligible, in case of negative HCV RNA test results\n- 4b) Patients with positive local test result during screening for chronic hepatitis B virus (HBV) infection (defined by hepatitis B surface antigen [HBsAg] positivity). Patients with occult or prior HBV infection (defined as negative HBsAg and positive total hepatitis B core antibody [HBcAb]) may be included if HBV DNA was undetectable (local test result), provided that they are willing to undergo ongoing DNA testing. Patients who have protective titers of hepatitis B surface antibody (HBsAb) after vaccination or prior but cured hepatitis B are eligible\n- 4c) Patients with Seropositive (local test during screening) for, or history of active viral infection with human immunodeficiency virus (HIV)\n- 4d) Patients with known active systemic bacterial, viral, fungal, or other infection at screening, including patients with suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay). Antiviral or antibacterial prophylaxis may be administered as per institutional guidelines\n- 4e) Patients with positive results for the human T-lymphotropic 1 virus (HTLV-1). HTLV testing during screening is required for patients at sites in endemic countries (Japan and Melanesia and countries in the Caribbean basin, South America, Central America, and sub-Saharan Africa)\n- 4f) Patients with known CNS lymphoma involvement"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-free survival (PFS) is defined as time from date of randomization until Progressive Disease or death from any cause. In this trial the primary endpoint is PFS as assessed by the investigator. Disease progression will be determined based on the Lugano Response Criteria for Malignant Lymphoma (Cheson et al., 2014; Appendix F).","definition_or_measurement_approach":"PFS defined as time from randomization to progressive disease or death from any cause; assessed by investigator; disease progression determined per Lugano Response Criteria for Malignant Lymphoma (Cheson et al., 2014; Appendix F)."}

Secondary endpoints

  • {"endpoint_text":"- Event-free survival (EFS) as assessed by the investigator","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Metabolic, positron emission tomography (PET)-negative complete response (CR) rate at end of treatment (EOT) as assessed by the BIRC","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Metabolic, PET-negative CR rate at EOT as assessed by the investigator","definition_or_measurement_approach":""}
  • {"endpoint_text":"- ORR at EOT as assessed by the investigator","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time to next anti-lymphoma treatment (TTNT)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Duration of CR as assessed by the investigator","definition_or_measurement_approach":""}
  • {"endpoint_text":"- EFS rate at three (3) years as assessed by the investigator","definition_or_measurement_approach":""}
  • {"endpoint_text":"- PFS rate at three (3) years as assessed by the investigator","definition_or_measurement_approach":""}
  • {"endpoint_text":"- OS rate at three (3) years","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence and severity of treatment emergent adverse events (TEAEs) from the first dose of study medication until the 90th day (inclusive) after last dose of study medication.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- PFS as assessed by the investigator by COO subtype","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Investigator-assessed EFS by COO subtype","definition_or_measurement_approach":""}
  • {"endpoint_text":"- OS by COO subtype","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Metabolic, PET-negative CR rate at EOT as assessed by the BIRC by COO subtype","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Metabolic, PET-negative CR rate at EOT as assessed by the investigator by COO subtype","definition_or_measurement_approach":""}
  • {"endpoint_text":"- PFS as assessed by the investigator by locally determined histological subtype","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Investigator assessed EFS by locally determined histological subtype","definition_or_measurement_approach":""}
  • {"endpoint_text":"- OS by locally determined histological subtype","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Metabolic, PET-negative CR rate at EOT as assessed by the BIRC by locally determined histological subtype","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Metabolic, PET-negative CR rate at EOT as assessed by the investigator by locally determined histological subtype","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Two (2)-year rate of relapse with CNS involvement, as assessed by the investigator","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Health-related quality of life (HRQoL), using the European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 and Functional Assessment of Cancer Therapy for Patients with Lymphoma (FACT-Lym) standardized instruments","definition_or_measurement_approach":"Assessed using EORTC QLQ-C30 and FACT-Lym instruments"}
  • {"endpoint_text":"- Serum concentration of tafasitamab at specific time points (trough and maximum plasma concentration (Cmax) levels)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence of anti-tafasitamab antibody formation, titer determination of confirmed positive samples","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
880
Recruitment Window Months
63
Consent Approach
Signed written informed consent (ICF) required from participants (adults aged 18 to 80). Subject information and ICF documents (including pregnancy-specific and optional genetic/genomic consent forms) are provided in multiple local languages (examples in file list: English, French, German, Spanish, Italian, Hungarian, Polish, Romanian, Czech, Slovak, etc.). No assent procedures for minors are provided (minors excluded).

Geography

Total Number Of Sites
104
Total Number Of Participants
392

France

Earliest CTIS Part Ii Submission Date
28-03-2024
Latest Decision Or Authorization Date
22-04-2024
Processing Time Days
25
Number Of Sites
13
Number Of Participants
45

Sites

Site Name
Centre Hospitalier De Versailles
Department Name
Hematology and Oncology
Contact Person Name
Caroline Besson
Contact Person Email
cbesson@ght78sud.fr
Site Name
Centre Hospitalier Le Mans
Department Name
Hematology
Contact Person Name
Kamel Laribi
Contact Person Email
klaribi@ch-lemans.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Hematology and Cell Therapy
Contact Person Name
Stephanie Guidez
Site Name
Institut Bergonie
Department Name
Hematology
Contact Person Name
Fontanet Bijou
Contact Person Email
f.bijou@bordeaux.unicancer.fr
Site Name
Groupement Des Hopitaux De L'Institut Catholique De Lille
Department Name
Onco-hematology
Contact Person Name
Sandy Amorim
Contact Person Email
amorim.sandy@ghicl.net
Site Name
CHRU De Nancy
Department Name
Haematology and Internal Medicine
Contact Person Name
Pierre Feugier
Contact Person Email
p.feugier@chru-nancy.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Clinical Hematology
Contact Person Name
Gandhi Laurent Damaj
Contact Person Email
damaj-gl@chu-caen.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Hematology
Contact Person Name
Ludovic Fouillet
Site Name
Centre Hospitalier Bretagne Atlantique
Department Name
Hematology
Contact Person Name
Brieuc Cherel
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Clinical Hematology and Cell Therapy
Contact Person Name
Kamal-Krimo Bouabdallah
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hematology
Contact Person Name
Thomas Gastinne
Contact Person Email
thomas.gastinne@chu-nantes.fr
Site Name
Centre Hospitalier Intercommunal De Cornouaille
Department Name
Internal Medicine, Haematology and Infectious Diseases
Contact Person Name
Ronan Le Calloch
Contact Person Email
r.lecalloch@ch-cornouaille.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Clinical Hematology
Contact Person Name
Lysiane Molina
Contact Person Email
LMolina@chu-grenoble.fr

Ireland

Earliest CTIS Part Ii Submission Date
28-03-2024
Latest Decision Or Authorization Date
19-04-2024
Processing Time Days
22
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
St Vincent's University Hospital
Department Name
Haematology
Contact Person Name
Liam Smyth
Contact Person Email
liamsmyth@svhg.ie

Austria

Earliest CTIS Part Ii Submission Date
28-03-2024
Latest Decision Or Authorization Date
24-04-2024
Processing Time Days
27
Number Of Sites
7
Number Of Participants
29

Sites

Site Name
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
Department Name
Department of Internal Medicine III, Hematology and Oncology
Contact Person Name
Michael Panny
Contact Person Email
michael.panny@oegk.at
Site Name
Noe LGA Gesundheit Region Mitte GmbH
Department Name
University Hospital St. Poelten, Department of Internal Medicine I
Contact Person Name
Petra Pichler-Izmir
Site Name
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Department Name
LKH Rankweil, Department of Internal Medicine II, Interne E
Contact Person Name
Bernd Hartmann
Contact Person Email
bernd.hartmann@lkhf.at
Site Name
Medizinische Universitaet Innsbruck
Department Name
Department of Internal Medicine V, Hematology and Oncology
Contact Person Name
Wolfgang Willenbacher
Site Name
Medical University Of Vienna
Department Name
Department of Internal Medicine I, Clinical Division of Hematology and Hemostaseology
Contact Person Name
Philipp Staber
Site Name
Ordensklinikum Linz GmbH
Department Name
Department of Internal Medicine I: Medical Oncology and Hematology
Contact Person Name
Manuel Orlinger
Site Name
Kepler Universitaetsklinikum GmbH
Department Name
Med Campus III, Department of Hematology and Oncology
Contact Person Name
Clemens Schmitt

Romania

Earliest CTIS Part Ii Submission Date
28-03-2024
Latest Decision Or Authorization Date
23-04-2024
Processing Time Days
26
Number Of Sites
6
Number Of Participants
17

Sites

Site Name
Onco Card S.R.L.
Department Name
Hematology
Contact Person Name
Mihaela Cornelia Lazaroiu
Contact Person Email
ellalaz@yahoo.com
Site Name
Spitalul Clinic Municipal Filantropia Craiova
Department Name
Hematology
Contact Person Name
Luminita Ocroteala
Contact Person Email
Diaconu_Luminita@yahoo.com
Site Name
Spitalul Universitar De Urgenta Bucuresti
Department Name
Hematology
Contact Person Name
Horia Bumbea
Contact Person Email
horiabum@gmail.com
Site Name
Institutul Clinic Fundeni
Department Name
Hematology and Bone Marrow Transplantation Center
Contact Person Name
Daniel Coriu
Contact Person Email
Daniel_Coriu@yahoo.com
Site Name
Institutul Regional De Oncologie Iasi
Department Name
Hematology
Contact Person Name
Catalin Doru Danaila
Contact Person Email
c_danaila@yahoo.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Hematology
Contact Person Name
Delia Monica Dima
Contact Person Email
Deli_Dima@yahoo.com

Hungary

Earliest CTIS Part Ii Submission Date
28-03-2024
Latest Decision Or Authorization Date
22-04-2024
Processing Time Days
25
Number Of Sites
5
Number Of Participants
22

Sites

Site Name
Orszagos Onkologiai Intezet
Department Name
Department of Medical Oncology and Hematology "A"
Contact Person Name
Tamas Schneider
Contact Person Email
schneider@oncol.hu
Site Name
University Of Debrecen
Department Name
Clinic of Internal Medicine
Contact Person Name
Arpad Illes
Contact Person Email
illes.arpad@med.unideb.hu
Site Name
Semmelweis University
Department Name
Department of Internal Medicine and Haematology
Contact Person Name
Zsolt Nagy
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
2nd Department of Internal Medicine - Hematology
Contact Person Name
Eszter Sari
Contact Person Email
sarieszter@gmail.com
Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
Department of Hematology
Contact Person Name
Laszlo Rejto
Contact Person Email
lrejto@med.unideb.hu

Poland

Earliest CTIS Part Ii Submission Date
28-03-2024
Latest Decision Or Authorization Date
24-04-2024
Processing Time Days
27
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Oddział Hematoonkologii z Pododdziałem Chemioterapii Dziennej
Contact Person Name
Magdalena Witkowska
Contact Person Email
magdamalicka@gmail.com
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Układu Chłonnego
Contact Person Name
Anna Dąbrowska-Iwanicka

Slovakia

Earliest CTIS Part Ii Submission Date
28-03-2024
Latest Decision Or Authorization Date
19-04-2024
Processing Time Days
22
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Univerzitna nemocnica L. Pasteura Kosice
Department Name
Hematology and Oncohematology
Contact Person Name
Tomáš Guman
Contact Person Email
guman@post.sk
Site Name
National Oncology Institute
Department Name
Clinic of Oncology-Hematology
Contact Person Name
Ľuboš Drgoňa
Contact Person Email
lubos.drgona@nou.sk

Italy

Earliest CTIS Part Ii Submission Date
28-03-2024
Latest Decision Or Authorization Date
22-04-2024
Processing Time Days
25
Number Of Sites
22
Number Of Participants
77

Sites

Site Name
Azienda Ospedale-Universita Padova
Department Name
Hematology and Immunology Clinic
Contact Person Name
Francesco Piazza
Contact Person Email
francesco.piazza@unipd.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
Hematology Unit
Contact Person Name
Luca Arcaini
Contact Person Email
luca.arcaini@unipv.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Hematology Unit
Contact Person Name
Roberto Massimo Lemoli
Contact Person Email
roberto.lemoli@unige.it
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
Hematology Unit
Contact Person Name
Alessandro Morotti
Contact Person Email
alessandro.morotti@unito.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna (Rimini)
Department Name
Hematology Unit
Contact Person Name
Anna Merli
Contact Person Email
anna.merli@auslromagna.it
Site Name
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
Department Name
Hematology Unit
Contact Person Name
Manuela Zanni
Contact Person Email
manuela.zanni@ospedale.al.it
Site Name
European Institute Of Oncology S.r.l.
Department Name
Division of Clinical Hemato-Oncology
Contact Person Name
Enrico Derenzini
Contact Person Email
enrico.derenzini@ieo.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna (Ravenna)
Department Name
Hematology Unit
Contact Person Name
Monica Tani
Contact Person Email
monica.tani@auslromagna.it
Site Name
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Department Name
Unit of Hematology with Bone Marrow Transplant
Contact Person Name
Francesco Di Raimondo
Contact Person Email
diraimon@unict.it
Site Name
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Department Name
The Hematology Operating Unit I
Contact Person Name
Caterina Patti
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Department Name
Department of Medical Oncology and Hematology
Contact Person Name
Umberto Vitolo
Contact Person Email
umberto.vitolo@ircc.it
Site Name
Ospedale Vito Fazzi Lecce
Department Name
The Hematology Operating Unit I
Contact Person Name
Nicola Di Renzo
Contact Person Email
direnzo.ematolecce@gmail.com
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Hematology Unit
Contact Person Name
Gerardo Musuraca
Contact Person Email
gerardo.musuraca@irst.emr.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Department Name
Hematology Unit
Contact Person Name
Silvia Ferrari
Contact Person Email
s.ferrari@asst-pg23.it
Site Name
Humanitas Research Hospital
Department Name
Department of Medical Oncology - Haematology
Contact Person Name
Monica Balzarotti
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
Hematology Unit
Contact Person Name
Gianluca Gaidano
Contact Person Email
gianluca.gaidano@med.uniupo.it
Site Name
Azienda Ospedaliera S Maria Di Terni
Department Name
Oncology
Contact Person Name
Arcangelo Liso
Contact Person Email
arcangelo.liso@aospterni.it
Site Name
Azienda Ospedaliera Universitaria Senese
Department Name
Hematology Unit
Contact Person Name
Alberto Fabbri
Contact Person Email
a.fabbri@ao-siena.toscana.it
Site Name
Pia Fondazione Di Culto E Religione Card G Panico
Department Name
Hematology Unit
Contact Person Name
Vincenzo Pavone
Contact Person Email
enzopavone@libero.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Hematology Unit
Contact Person Name
Alessandra Tucci
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Department of Molecular Biotechnology and Health Sciences
Contact Person Name
Federica Cavallo
Contact Person Email
f.cavallo@unito.it
Site Name
Azienda Sanitaria Universitaria Giuliano Isontina
Department Name
Department of Hematology
Contact Person Name
Francesco Zaja

Czechia

Earliest CTIS Part Ii Submission Date
28-03-2024
Latest Decision Or Authorization Date
22-04-2024
Processing Time Days
25
Number Of Sites
7
Number Of Participants
52

Sites

Site Name
Fakultni Nemocnice V Motole
Department Name
Clinic of Oncology
Contact Person Name
Kateřina Kopečková
Contact Person Email
katerina.kopeckova@fnmotol.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Clinic of Hematology
Contact Person Name
Heidi Móciková
Contact Person Email
heidi.mocikova@fnkv.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
I. Internal hematological clinic
Contact Person Name
Marek Trněný
Contact Person Email
trneny@cesnet.cz
Site Name
University Hospital Olomouc
Department Name
Clinic of Hemato-Oncology
Contact Person Name
Aleš Obr
Contact Person Email
ales.obr@fnol.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Clinic of Internal Medicine - Hematology and Oncology
Contact Person Name
Jozef Michalka
Contact Person Email
michalka.jozef@fnbrno.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Clinic of Hematooncology
Contact Person Name
Juraj Ďuras
Contact Person Email
juraj.duras@fno.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
4th Internal Clinic of Hematology
Contact Person Name
David Belada
Contact Person Email
beladad@lfhk.cuni.cz

Germany

Earliest CTIS Part Ii Submission Date
28-03-2024
Latest Decision Or Authorization Date
30-04-2024
Processing Time Days
33
Number Of Sites
22
Number Of Participants
83

Sites

Site Name
Klinikum Chemnitz gGmbH
Department Name
Clinic of Internal Medicine III Hematology, Oncology, Stem Cell Transplantation
Contact Person Name
Mathias Hänel
Contact Person Email
m.haenel@skc.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Internal Medicine II Hematology, Oncology, clinical immunology and rheumatology
Contact Person Name
Stefan Wirths
Site Name
Helios Universitaetsklinikum Wuppertal
Department Name
Medical Clinic I Haematology, Nephrology, Oncology and Palliative Medicine
Contact Person Name
Silke Schostok
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medical Clinic of Hematology, Oncology and Tumor Immunology
Contact Person Name
Frederik Damm
Contact Person Email
frederik.damm@charite.de
Site Name
Universitaetsklinikum Magdeburg AöR
Department Name
Department of Hematology and Oncology
Contact Person Name
Enrico Schalk
Contact Person Email
enrico.schalk@med.ovgu.de
Site Name
Carl-Thiem-Klinikum Cottbus gGmbH
Department Name
Clinic for Hematology and Oncology
Contact Person Name
Martin Schmidt-Hieber
Contact Person Email
M.Schmidt_Hieber@mul-ct.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Hematology and Int. Oncology
Contact Person Name
Ulf Schnetzke
Contact Person Email
ulf.schnetzke@med.uni-jena.de
Site Name
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden GmbH
Department Name
Clinic Internal Med. III, Hematology/Oncology,
Contact Person Name
Wolfgang Blau
Site Name
Universitaetsklinikum Schleswig-Holstein AöR (Luebeck)
Department Name
Clinic for Haematology and Oncology
Contact Person Name
Niklas Gebauer
Contact Person Email
niklas.gebauer@uksh.de
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Hematology, Hemostaseology, Internal Oncology and Pneumology
Contact Person Name
Georg Lenz
Contact Person Email
georg.lenz@ukmuenster.de
Site Name
Philipps-Universitaet Marburg
Department Name
Hematology/Oncology/Immunology
Contact Person Name
Jörg Hoffmann
Site Name
Universitatsklinikum Wurzburg AöR
Department Name
Internal Medicine Center
Contact Person Name
Johannes Duell
Contact Person Email
Duell_J@ukw.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Clinic for Oncology, Hematology, Hemostaseology and Stem Cell Transplantation
Contact Person Name
Mareike Tometten
Contact Person Email
mtometten@ukaachen.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medical Clinic and Policlinic III
Contact Person Name
Moritz Kleemiß
Contact Person Email
moritz.kleemiss@ukbonn.de
Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
Clinic for Internal Medicine III
Contact Person Name
Uwe Martens
Contact Person Email
uwe.martens@slk-kliniken.de
Site Name
Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbH
Department Name
Clinic for Haematology and Oncology
Contact Person Name
Tobias Gaska
Contact Person Email
t.gaska@bk-paderborn.de
Site Name
Klinikum Kassel GmbH
Department Name
Hematology, Oncology and Immunology Clinic
Contact Person Name
Barbara Ritter
Contact Person Email
barbara.ritter.studien@gnh.net
Site Name
Universitaetsklinikum Augsburg
Department Name
II. Medical Clinic
Contact Person Name
Boris Kubuschok
Contact Person Email
Boris.Kubuschok@uk-augsburg.de
Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
Department for Internal Medicine IV Hematology/Oncology/Hemostaseology
Contact Person Name
Thomas Weber
Contact Person Email
thomas.weber@uk-halle.de
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Department for Hematology/Oncology
Contact Person Name
Christian Scholz
Contact Person Email
christianw.scholz@vivantes.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Hematology, Internal Oncology and Pneumology
Contact Person Name
Georg Heß
Contact Person Email
georg.hess@unimedizin-mainz.de
Site Name
Universitaetsmedizin Goettingen
Department Name
Department of Hematology/Oncology
Contact Person Name
Gerald Wulf

Spain

Earliest CTIS Part Ii Submission Date
28-03-2024
Latest Decision Or Authorization Date
19-04-2024
Processing Time Days
22
Number Of Sites
17
Number Of Participants
53

Sites

Site Name
Hospital Universitario Lucus Augusti
Department Name
Hematology
Contact Person Name
Maria Esperanza Lavilla Rubira
Site Name
Hospital Germans Trias I Pujol
Department Name
Clinical Hematology
Contact Person Name
Juan Manuel Sancho Cia
Contact Person Email
jsancho@iconcologia.net
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Hematology
Contact Person Name
Francisco Javier Lopez-Jimenez
Contact Person Email
jljimenez@salud.madrid.org
Site Name
Hospital Universitario Virgen De Valme
Department Name
Hematology and Hemotherapy
Contact Person Name
Eduardo Rios Herranz
Site Name
Hospital Universitario 12 De Octubre
Department Name
Hematology
Contact Person Name
Tycho Stephan Baumann
Contact Person Email
tycho.baumann@gmail.com
Site Name
Hospital Universitario Araba
Department Name
Hematology
Contact Person Name
Ariane Unamunzaga Cilaurren
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Hematology
Contact Person Name
Sergio Ramos Cillan
Contact Person Email
sergio.ramosc@quironsalud.com
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Hematology
Contact Person Name
Agustin Penedo Coello
Contact Person Email
apenedo@hmhospitales.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Contact Person Name
Pau Abrisqueta Costa
Contact Person Email
pabrisqueta@vhio.net
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Medical Oncology
Contact Person Name
Natalia Palazon Carrion
Contact Person Email
npalazoncarrion@gmail.com
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Hematology
Contact Person Name
Aranzazu Alonso Alonso
Contact Person Email
Aranzazu.Alonso@quironsalud.es
Site Name
Institut Catala D'oncologia (L'hospitalet De Llobregat)
Department Name
Hematology
Contact Person Name
Eva Gonzales Barca
Contact Person Email
e.gonzalez@iconcologia.net
Site Name
Institut Catala D'oncologia (Girona)
Department Name
Hematology
Contact Person Name
Nicholas John Kelleher
Contact Person Email
nkelleher@iconcologia.net
Site Name
Hospital Universitario De Navarra
Department Name
Hematology
Contact Person Name
Jose Maria Arguinano Perez
Contact Person Email
jm.arguinano.perez@navarra.es
Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
Hematology
Contact Person Name
Eva Maria Donato Martin
Contact Person Email
donato_eva@gva.es
Site Name
Hospital Universitario De Salamanca
Department Name
Hematology
Contact Person Name
Alejandro Martin Garcia-Sancho
Site Name
Hospital De Jerez De La Frontera
Department Name
Hematology
Contact Person Name
Maria Jose Berruezo Salazar
Contact Person Email
mjberruezo3377@gmail.com

Sponsor

Primary sponsor

Full Name
Incyte Corp.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Name
Icon Development Solutions LLC
Name
Psi Cro AG
Name
CluePoints
Responsibilities
Central Monitoring Platform
Name
Suvoda LLC
Responsibilities
IVRS - treatment allocation
Name
Bioclinica Inc.
Responsibilities
Medical Image analysis/review
Name
Medidata Solutions Inc.

Third parties

  • {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"Sample storage and distribution","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"Universitaetsklinikum Wuerzburg AöR","duties_or_roles":"Histopathology and long-term sample storage (of RNA)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Medical Image analysis/review","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Italy","full_name":"Universita' Degli Studi Di Torino","duties_or_roles":"Long-term sample storage (ctDNA and MRD)","organisation_type":"Educational Institution"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"IVRS - treatment allocation","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Foresight Diagnostics, Inc","duties_or_roles":"ctDNA analysis; plasma & cell pellet molecular profiling; Long-term sample storage (ctDNA)","organisation_type":"Industry"}
  • {"country":"Germany","full_name":"Universitaetsklinikum Schleswig-Holstein AöR","duties_or_roles":"Long-term sample storage (ctDNA and MRD)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CluePoints","duties_or_roles":"Central Monitoring Platform","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Eurofins Adme Bioanalyses","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Myonex Limited","duties_or_roles":"IMP sourcing","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Charite Universitaetsmedizin Berlin KöR","duties_or_roles":"WES and RNA-Seq Analysis","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Italy","full_name":"European Institute Of Oncology S.r.l.","duties_or_roles":"Histopathology","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"France","full_name":"Cerba","duties_or_roles":"HCV RNA & HBV DNA analysis","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Canada","full_name":"CIRION Biopharma Research Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
MINJUVI 200 mg powder for concentrate for solution for infusion
Active Substance
TAFASITAMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Authorisation Status
Marketing authorisation present (EU/1/21/1570/001) noted in product data
Orphan Designation
Yes
Maximum Dose
14.4 mg/kg
Investigational Product Name
LENALIDOMIDE
Active Substance
LENALIDOMIDE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Maximum Dose
25 mg
Combination Treatment
Yes

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