Clinical trial • Phase II • Haematology
ODRONEXTAMAB for B-cell non-Hodgkin lymphoma | Follicular lymphoma | Diffuse large B-cell lymphoma | Mantle cell lymphoma | Marginal zone lymphoma
Phase II trial of ODRONEXTAMAB for B-cell non-Hodgkin lymphoma | Follicular lymphoma | Diffuse large B-cell lymphoma | Mantle cell lymphoma | Marginal zon…
Overview
- Trial Therapeutic Area
- Haematology
- Trial Disease
- B-cell non-Hodgkin lymphoma | Follicular lymphoma | Diffuse large B-cell lymphoma | Mantle cell lymphoma | Marginal zone lymphoma
- Trial Stage
- Phase II
- Drug Modality
- Bispecific antibody
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 15-04-2024
- First CTIS Authorization Date
- 28-05-2024
Trial design
open-label, none/not specified-controlled Phase II trial across 37 sites in Poland, France, Italy and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 351
- Trial Duration For Participant
- 730
Eligibility
Recruits 351 The CTIS record indicates isVulnerablePopulationSelected = true. Specific details on consent/assent handling for vulnerable participants are not provided in the available metadata/documents..
- Vulnerable Population
- The CTIS record indicates isVulnerablePopulationSelected = true. Specific details on consent/assent handling for vulnerable participants are not provided in the available metadata/documents.
Inclusion criteria
- {"criterion_text":"- For the FL grade 1-3a cohort only: Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible for this cohort but may be included in the \"other B-NHL\" cohort. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification"}
- {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1"}
- {"criterion_text":"- Other protocol-defined inclusion criteria apply"}
- {"criterion_text":"- Adequate bone marrow, hepatic, and renal function as defined in the protocol"}
- {"criterion_text":"- Disease-specific cohorts: Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment. FL grade 1-3a cohort: Patients with FL grade 1-3a that has relapsed after or is refractory to at least 2 prior lines of systemic therapy, as defined in the protocol"}
- {"criterion_text":"- DLBCL cohort: Patients with DLBCL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol"}
- {"criterion_text":"- MCL after BTK inhibitor therapy cohort: Patients with MCL who have relapsed or refractory disease to at least one prior line of systemic therapy and had prior treatment with a BTK inhibitor."}
- {"criterion_text":"- MZL cohort: Patients with MZL that have relapsed or is refractory to at least 2 prior lines of systemic therapy."}
- {"criterion_text":"- Other B-NHL cohort: Patients with B-NHL other than FL grade 1-3a, DLBCL, MCL, or MZL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol. New enrollment stopped for patients with Burkitt lymphoma and Burkitt-like lymphoma."}
- {"criterion_text":"- Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment"}
- {"criterion_text":"- Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI)"}
Exclusion criteria
- {"criterion_text":"- Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS Non-Hodgkin Lymphoma (NHL) (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI)."}
- {"criterion_text":"- Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy"}
- {"criterion_text":"- Other protocol-defined exclusion criteria apply"}
- {"criterion_text":"- Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter."}
- {"criterion_text":"- History of allogeneic stem cell transplantation"}
- {"criterion_text":"- Criterion removed"}
- {"criterion_text":"- Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug"}
- {"criterion_text":"- History of neurodegenerative condition or CNS movement disorder. Patients with a history of seizure within 12 months prior to study enrollment are excluded"}
- {"criterion_text":"- Another malignancy except B-NHL in the past 5 years, with the exception of non-melanoma skin cancer that has undergone potentially curative therapy or in situ cervical carcinoma, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent."}
- {"criterion_text":"- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; cytomegalovirus (CMV) infection as noted by detectable levels on a blood polymerase chain reaction (PCR) assay as defined in the protocol or other uncontrolled infections"}
- {"criterion_text":"- Known hypersensitivity to both allopurinol and rasburicase"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint of the study for each of the 5 disease-specific cohorts is as follows: ORR according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review.","definition_or_measurement_approach":"Objective Response Rate (ORR) measured according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) as assessed by independent central review."}
Secondary endpoints
- {"endpoint_text":"- ORR according to the Lugano Classification and as assessed by local investigator evaluation","definition_or_measurement_approach":"Objective Response Rate measured according to the Lugano Classification, assessed by local investigator evaluation."}
- {"endpoint_text":"- Complete response (CR) rate according to the Lugano Classification and as assessed by local investigator evaluation and independent central review.","definition_or_measurement_approach":"Complete response rate per Lugano Classification assessed by both local investigator evaluation and independent central review."}
- {"endpoint_text":"- Progression free survival (PFS) according to the Lugano Classification and as assessed by independent central review and local investigator evaluation","definition_or_measurement_approach":"Progression-free survival measured per Lugano Classification assessed by independent central review and local investigator."}
- {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":"Overall survival (time from enrollment/randomization to death from any cause)."}
- {"endpoint_text":"- Duration of response (DOR) according to the Lugano Classification and as assessed by independent central review and local investigator evaluation","definition_or_measurement_approach":"Duration of response per Lugano Classification, assessed by independent central review and local investigator."}
- {"endpoint_text":"- Disease control rate (DCR) according to the Lugano Classification and as assessed by independent central review and local investigator evaluation by independent central review and local investigator evaluation","definition_or_measurement_approach":"Disease control rate per Lugano Classification assessed by independent central review and local investigator."}
- {"endpoint_text":"- Incidence and severity of treatment emergent adverse events (TEAEs)","definition_or_measurement_approach":"Incidence and severity graded using standard adverse event criteria (as recorded in trial safety reporting)."}
- {"endpoint_text":"- Pharmacokinetics: concentration of odronextamab, incidence of anti-drug antibodies (ADA) to odronextamab over time, incidence of neutralizing antibodies (Nab) to odronextamab over time","definition_or_measurement_approach":"PK concentration measurements of odronextamab and immunogenicity assessments (ADA and neutralizing antibodies) over time using validated assays."}
- {"endpoint_text":"- Changes in scores of patient-reported outcomes as measured by EORTC QLQ-C30","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 scores."}
- {"endpoint_text":"- Changes in scores of patient-reported outcomes as measured by FACT-Lym","definition_or_measurement_approach":"Change from baseline in FACT-Lym scores."}
- {"endpoint_text":"- Changes in scores of patient-reported outcomes as measured by EQ-5D-3L","definition_or_measurement_approach":"Change from baseline in EQ-5D-3L scores."}
Recruitment
- Planned Sample Size
- 351
- Recruitment Window Months
- 72
- Consent Approach
- Informed consent is obtained using subject information and informed consent forms (SIS-ICF). Multiple language versions of SIS/ICF and patient-facing documents are present in the dossier (examples: EN, FR, PL, IT, DE, ES). A Pregnant Partner information/ICF document is also included. Specific details on assent or age-stratified consent processes are not provided in the available metadata.
Geography
- Total Number Of Sites
- 37
- Total Number Of Participants
- 225
Poland
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 31-10-2025
- Processing Time Days
- 516
- Number Of Sites
- 6
- Number Of Participants
- 75
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Bone marrow transplantation
- Principal Investigator Name
- Jan Walewski
- Principal Investigator Email
- jan.walewski@coi.waw.pl
- Contact Person Name
- Jan Walewski
- Contact Person Email
- jan.walewski@coi.waw.pl
- Site Name
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
- Department Name
- Hematology
- Principal Investigator Name
- Tadeusz Robak
- Principal Investigator Email
- robaktad@csk.umed.lodz.pl
- Contact Person Name
- Tadeusz Robak
- Contact Person Email
- robaktad@csk.umed.lodz.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Hematology
- Principal Investigator Name
- Michal Taszner
- Principal Investigator Email
- mtaszner@uck.gda.pl
- Contact Person Name
- Michal Taszner
- Contact Person Email
- mtaszner@uck.gda.pl
- Site Name
- Instytut Hematologii I Transfuzjologii
- Department Name
- Hematology
- Principal Investigator Name
- Ewa Lech-Maranda
- Principal Investigator Email
- ewamaranda@wp.pl
- Contact Person Name
- Ewa Lech-Maranda
- Contact Person Email
- ewamaranda@wp.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Klinika Hematologii, Terapii Komorkowych i Chorob Wewnetrznych
- Principal Investigator Name
- Tomasz Wrobel
- Principal Investigator Email
- tomasz_wrobel@wp.pl
- Contact Person Name
- Tomasz Wrobel
- Contact Person Email
- tomasz_wrobel@wp.pl
- Site Name
- Szpitale Pomorskie Sp. z o.o.
- Department Name
- Oddzial Hematologii i Transplantologii Szpiku
- Principal Investigator Name
- Adam Franciszek Witkowski
- Principal Investigator Email
- adam.wit12@gmail.com
- Contact Person Name
- Adam Franciszek Witkowski
- Contact Person Email
- adam.wit12@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 28-05-2024
- Latest Decision Or Authorization Date
- 30-10-2025
- Processing Time Days
- 520
- Number Of Sites
- 9
- Number Of Participants
- 45
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Clinical hematology
- Principal Investigator Name
- Corinne Haioun
- Principal Investigator Email
- corinne.haioun@aphp.fr
- Contact Person Name
- Corinne Haioun
- Contact Person Email
- corinne.haioun@aphp.fr
- Site Name
- Hopital Universitaire Pitie Salpetriere
- Department Name
- Clinical Hematology
- Principal Investigator Name
- Sylvain Choquet
- Principal Investigator Email
- sylvain.choquet@psl.aphp.fr
- Contact Person Name
- Sylvain Choquet
- Contact Person Email
- sylvain.choquet@psl.aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Caen Normandie
- Department Name
- Clinical hematology
- Principal Investigator Name
- Gandhi Damaj
- Principal Investigator Email
- damaj-gl@chu-caen.fr
- Contact Person Name
- Gandhi Damaj
- Contact Person Email
- damaj-gl@chu-caen.fr
- Site Name
- Hospital Hotel Dieu
- Department Name
- Clinical hematology
- Principal Investigator Name
- Benoit Tessoulin
- Principal Investigator Email
- benoit.tessoulin@chu-nantes.fr
- Contact Person Name
- Benoit Tessoulin
- Contact Person Email
- benoit.tessoulin@chu-nantes.fr
- Site Name
- Hopital Saint Louis
- Department Name
- Hemato-oncology
- Principal Investigator Name
- Catherine Thieblemont
- Principal Investigator Email
- catherine.thieblemont@aphp.fr
- Contact Person Name
- Catherine Thieblemont
- Contact Person Email
- catherine.thieblemont@aphp.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Clinical hematology
- Principal Investigator Name
- Emmanuel Bachy
- Principal Investigator Email
- emmanuel.bachy@chu-lyon.fr
- Contact Person Name
- Emmanuel Bachy
- Contact Person Email
- emmanuel.bachy@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Clinical hematology
- Principal Investigator Name
- Franck Morschhauser
- Principal Investigator Email
- franck.morschhauser@chru-lille.fr
- Contact Person Name
- Franck Morschhauser
- Contact Person Email
- franck.morschhauser@chru-lille.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Clinical hematology
- Principal Investigator Name
- Vincent Delwail
- Principal Investigator Email
- vincent.delwail@chu-poitiers.fr
- Contact Person Name
- Vincent Delwail
- Contact Person Email
- vincent.delwail@chu-poitiers.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Clinical hematology
- Principal Investigator Name
- Kamal Krimo Bouabdallah
- Principal Investigator Email
- Krimo.bouabdallah@chu-bordeaux.fr
- Contact Person Name
- Kamal Krimo Bouabdallah
- Contact Person Email
- Krimo.bouabdallah@chu-bordeaux.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 29-05-2024
- Latest Decision Or Authorization Date
- 30-10-2025
- Processing Time Days
- 519
- Number Of Sites
- 9
- Number Of Participants
- 25
Sites
- Site Name
- Azienda Ulss 3 Serenissima
- Department Name
- Hematology and bone marrow transplantation
- Principal Investigator Name
- Cristina Skert
- Principal Investigator Email
- cristina.skert@aulss3.veneto.it
- Contact Person Name
- Cristina Skert
- Contact Person Email
- cristina.skert@aulss3.veneto.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Clinical hematology
- Principal Investigator Name
- Vittorio Ruggero Zilioli
- Principal Investigator Email
- vittorioruggero.zilioli@ospedaleniguarda.it
- Contact Person Name
- Vittorio Ruggero Zilioli
- Contact Person Email
- vittorioruggero.zilioli@ospedaleniguarda.it
- Site Name
- Azienda Ospedaliero-Universitaria Maggiore Della Carita
- Department Name
- Clinical hematology
- Principal Investigator Name
- Gianluca Gaidano
- Principal Investigator Email
- gianluca.gaidano@med.uniupo.it
- Contact Person Name
- Gianluca Gaidano
- Contact Person Email
- gianluca.gaidano@med.uniupo.it
- Site Name
- Azienda Ospediera Ospedale Di Circolo E Fondazione Macchi
- Department Name
- Clinical hematology
- Principal Investigator Name
- Marco Brociner
- Principal Investigator Email
- marco.brociner@asst-settelaghi.it
- Contact Person Name
- Marco Brociner
- Contact Person Email
- marco.brociner@asst-settelaghi.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- Onco-hematology
- Principal Investigator Name
- Monica Tani
- Principal Investigator Email
- monicatani22@gmail.com
- Contact Person Name
- Monica Tani
- Contact Person Email
- monicatani22@gmail.com
- Site Name
- Hospital Santa Maria Della Misericordia
- Department Name
- Hematology and bone marrow transplantation
- Principal Investigator Name
- Leonardo Flenghi
- Principal Investigator Email
- flenghi@yahoo.it
- Contact Person Name
- Leonardo Flenghi
- Contact Person Email
- flenghi@yahoo.it
- Site Name
- Azienda USL IRCCS Di Reggio Emilia
- Department Name
- Clinical hematology
- Principal Investigator Name
- Stefano Luminari
- Principal Investigator Email
- stefano.luminari@ausl.re.it
- Contact Person Name
- Stefano Luminari
- Contact Person Email
- stefano.luminari@ausl.re.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Clinical hematology
- Principal Investigator Name
- Francesca Gaia Rossi
- Principal Investigator Email
- francescagaia.rossi@policlinico.mi.it
- Contact Person Name
- Francesca Gaia Rossi
- Contact Person Email
- francescagaia.rossi@policlinico.mi.it
- Site Name
- Alma Mater Studiorum Universita Di Bologna
- Department Name
- Clinical hematology
- Principal Investigator Name
- Pier Luigi Zinzani
- Principal Investigator Email
- pierluigi.zinzani@unibo.it
- Contact Person Name
- Pier Luigi Zinzani
- Contact Person Email
- pierluigi.zinzani@unibo.it
Germany
- Earliest CTIS Part Ii Submission Date
- 30-05-2024
- Latest Decision Or Authorization Date
- 29-10-2025
- Processing Time Days
- 517
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Universitaetsklinikum Halle (Saale) AöR
- Department Name
- Hematology oncology and hemostaseology
- Principal Investigator Name
- Thomas Weber
- Principal Investigator Email
- thomas.weber@uk-halle.de
- Contact Person Name
- Thomas Weber
- Contact Person Email
- thomas.weber@uk-halle.de
- Site Name
- Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts
- Department Name
- Hematology and oncology
- Principal Investigator Name
- Holger Hebart
- Principal Investigator Email
- holger.hebart@kliniken-ostalb.de
- Contact Person Name
- Holger Hebart
- Contact Person Email
- holger.hebart@kliniken-ostalb.de
Spain
- Earliest CTIS Part Ii Submission Date
- 28-05-2024
- Latest Decision Or Authorization Date
- 12-12-2025
- Processing Time Days
- 563
- Number Of Sites
- 11
- Number Of Participants
- 75
Sites
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hematology
- Principal Investigator Name
- Eva Giné Soca
- Principal Investigator Email
- egine@clinic.cat
- Contact Person Name
- Eva Giné Soca
- Contact Person Email
- egine@clinic.cat
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Hematology
- Principal Investigator Name
- Agustín Peneda Coello
- Principal Investigator Email
- apenedo@hmhospitales.com
- Contact Person Name
- Agustín Peneda Coello
- Contact Person Email
- apenedo@hmhospitales.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Hematology
- Principal Investigator Name
- Cecilia Carpio Segura
- Principal Investigator Email
- cecilia.carpio@vhir.org
- Contact Person Name
- Cecilia Carpio Segura
- Contact Person Email
- cecilia.carpio@vhir.org
- Site Name
- Institut Catala D'oncologia
- Department Name
- Hematology
- Principal Investigator Name
- Eva Marie Gonzalez Barca
- Principal Investigator Email
- smercadal@iconologia.net
- Contact Person Name
- Eva Marie Gonzalez Barca
- Contact Person Email
- smercadal@iconologia.net
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Hematology
- Principal Investigator Name
- Rafael Andreu Lapiedra
- Principal Investigator Email
- andreu_raflap@gva.es
- Contact Person Name
- Rafael Andreu Lapiedra
- Contact Person Email
- andreu_raflap@gva.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Clinical hematology
- Principal Investigator Name
- Silvana Novelli Canales
- Principal Investigator Email
- snovelli@santpau.cat
- Contact Person Name
- Silvana Novelli Canales
- Contact Person Email
- snovelli@santpau.cat
- Site Name
- University Hospital Son Espases
- Department Name
- Clinical hematology
- Principal Investigator Name
- Antonio Gutierrez Garcia
- Principal Investigator Email
- antoniom.gutierrez@ssib.es
- Contact Person Name
- Antonio Gutierrez Garcia
- Contact Person Email
- antoniom.gutierrez@ssib.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Hematology
- Principal Investigator Name
- Sergio Ramos Cillan
- Principal Investigator Email
- sergio.ramosc@quironsalud.com
- Contact Person Name
- Sergio Ramos Cillan
- Contact Person Email
- sergio.ramosc@quironsalud.com
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Hematology and hemotherapy
- Principal Investigator Name
- Aranzazu Alonso Alonso
- Principal Investigator Email
- Aranzazu.Alonso.Alonso@quironsalud.es
- Contact Person Name
- Aranzazu Alonso Alonso
- Contact Person Email
- Aranzazu.Alonso.Alonso@quironsalud.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Hematology
- Principal Investigator Name
- Ana Jimenez Ubieto
- Principal Investigator Email
- anitiju@hotmail.com
- Contact Person Name
- Ana Jimenez Ubieto
- Contact Person Email
- anitiju@hotmail.com
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Hematology
- Principal Investigator Name
- Alejandro Martin Garcia-Sancho
- Principal Investigator Email
- amartingar@usal.es
- Contact Person Name
- Alejandro Martin Garcia-Sancho
- Contact Person Email
- amartingar@usal.es
Sponsor
Primary sponsor
- Full Name
- Regeneron Pharmaceuticals Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Syneos Health Inc.
- Responsibilities
- codes 1,12,15 (Contract Research Organisation),6,7,8
Third parties
- {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"eCOA, Health outcome reporting/reading center","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Immunologix","duties_or_roles":"code 4","organisation_type":"Health care"}
- {"country":"Slovakia","full_name":"SanaClis s.r.o.","duties_or_roles":"IMP release, Returns and Destruction","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"codes 1,12,15 (Contract Research Organisation),6,7,8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"ICON Medical Imaging","duties_or_roles":"Central Imaging, Reading Center","organisation_type":"Industry"}
- {"country":"United States","full_name":"IQVIA Laboratories LLC","duties_or_roles":"Reporting, Logistics Management, Specimen storage and management; codes 4,5,6","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- Odronextamab
- Active Substance
- ODRONEXTAMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- Intravenous
- Authorisation Status
- Authorised
- Orphan Designation
- Yes
- Maximum Dose
- 320 mg
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