Clinical trial • Phase II • Haematology
GOLCADOMIDE for Follicular lymphoma (advanced stage)
Phase II trial of GOLCADOMIDE for Follicular lymphoma (advanced stage).
Overview
- Trial Therapeutic Area
- Haematology
- Trial Disease
- Follicular lymphoma (advanced stage)
- Trial Stage
- Phase II
- Drug Modality
- Small molecule|Monoclonal antibody|Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 31-05-2024
- First CTIS Authorization Date
- 24-09-2024
Trial design
Randomised, open-label, comparator arms include: rituximab (iv; listed max daily dose 375 mg/m2 where provided) as comparator agent; chemotherapy comparators include bendamustine (iv; listed max daily dose 90 mg/m2), cyclophosphamide (iv; listed max daily dose 750 mg/m2), doxorubicin (iv; listed max daily dose 50 mg/m2), vincristine sulfate (iv; listed max daily dose 2 mg), and corticosteroids prednisone/prednisolone/betamethasone (oral/iv; listed max daily dose 100 mg). golcadomide is the investigational oral agent (test product) given in combination with rituximab in the experimental arm.-controlled Phase II trial in France, Germany, Italy and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Comparator arms include: Rituximab (IV; listed max daily dose 375 mg/m2 where provided) as comparator agent; Chemotherapy comparators include Bendamustine (IV; listed max daily dose 90 mg/m2), Cyclophosphamide (IV; listed max daily dose 750 mg/m2), Doxorubicin (IV; listed max daily dose 50 mg/m2), Vincristine sulfate (IV; listed max daily dose 2 mg), and corticosteroids Prednisone/Prednisolone/Betamethasone (oral/IV; listed max daily dose 100 mg). Golcadomide is the investigational oral agent (test product) given in combination with rituximab in the experimental arm.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 113
- Trial Duration For Participant
- 336
Eligibility
Recruits 113 No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants are adults (>18); informed consent obtained from participants. No assent or special minor-consent procedures are mentioned..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants are adults (>18); informed consent obtained from participants. No assent or special minor-consent procedures are mentioned.
Inclusion criteria
- {"criterion_text":"- Participants over the age of 18"}
- {"criterion_text":"- Participants meeting all inclusion criteria regarding disease characteristics, laboratory values and reproductive capacity status would be considered eligible."}
Exclusion criteria
- {"criterion_text":"- Medical conditions or physical and laboratory test results incompatible with participation in the trial, such as significant medical disease, active infection, laboratory abnormality, incapacitating psychiatric illness"}
- {"criterion_text":"- Other lymphoma subtypes"}
- {"criterion_text":"- Specific allergies or adverse reactions to certain types of medication"}
Endpoints
Primary endpoints
- {"endpoint_text":"- To evaluate if the patient´s condition improves using CMR. This means that at different times during the treatment, such as 6 months or 12 months after the start of treatment, the person's disease has completely responded to the treatment.","definition_or_measurement_approach":"CMR (Complete Metabolic Response) assessed at specified time points (examples given: 6 months and 12 months after start of treatment); defined as absence of detectable disease on clinical/metabolic tests as described in the main objective."}
Secondary endpoints
- {"endpoint_text":"- To evaluate any negative side effects or adverse events (AE), which means an occurrence that has a negative impact on the health or well-being of a participant. This includes any new side effects that start after the treatment begins, which we call \"Treatment-Emergent Adverse Events\" (TEAEs).","definition_or_measurement_approach":"Collection and evaluation of adverse events (AEs) including Treatment-Emergent Adverse Events (TEAEs) during treatment."}
- {"endpoint_text":"- To evaluate all AE, including TEAE and laboratory test as well as CMR data collected during the treatment of the Golcadomide and rituximab combination.","definition_or_measurement_approach":"Comprehensive safety assessment including AEs, TEAEs, laboratory tests and CMR data during Golcadomide+rituximab treatment."}
- {"endpoint_text":"- To evaluate the overall response rate (ORR), the percentage of participants whose cancer shrinks or disappears.","definition_or_measurement_approach":"ORR measured as percentage of participants with tumour shrinkage or disappearance based on response assessments."}
- {"endpoint_text":"- To evaluate PFS, the time from when we start the treatment until the disease gets worse or the patient passes away.","definition_or_measurement_approach":"Progression-Free Survival (PFS) measured as time from treatment start to disease progression or death."}
- {"endpoint_text":"- To evaluate OS, which is the time from when we start the treatment until the patient passes away.","definition_or_measurement_approach":"Overall Survival (OS) measured as time from treatment start to death from any cause."}
- {"endpoint_text":"- To evaluate all AE, including TEAE and laboratory test as well as CMR, ORR, PFS and OS data collected during the treatment of the rituximab and chemotherapy combination.","definition_or_measurement_approach":"Comprehensive evaluation of safety (AEs/TEAEs/labs) and efficacy endpoints (CMR, ORR, PFS, OS) for rituximab+chemotherapy arm."}
Recruitment
- Planned Sample Size
- 113
- Recruitment Window Months
- 49
- Consent Approach
- Informed consent obtained from adult participants (study includes participants >18). Country-specific subject information and informed consent forms are provided (documents available in French, German, Italian, Spanish, Polish). Pregnancy-specific information/ICFs and pregnancy prevention materials are included in the documentation; consent is participant-provided (no assent/minor consent procedures are described).
Geography
- Total Number Of Sites
- 17
- Total Number Of Participants
- 113
France
- Earliest CTIS Part Ii Submission Date
- 06-09-2024
- Latest Decision Or Authorization Date
- 14-08-2025
- Processing Time Days
- 342
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Hematology
- Principal Investigator Name
- Franck MORSCHHAUSER
- Principal Investigator Email
- franck.morchhauser@chru-lille.fr
- Contact Person Name
- Franck MORSCHHAUSER
- Contact Person Email
- franck.morchhauser@chru-lille.fr
- Site Name
- Institut Curie
- Department Name
- Hematology
- Principal Investigator Name
- Clementine SARKOZY
- Principal Investigator Email
- clementine.sarkozy@curie.fr
- Contact Person Name
- Clementine SARKOZY
- Contact Person Email
- clementine.sarkozy@curie.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Haematology and Cell Therapy Department
- Principal Investigator Name
- Stephanie GUIDEZ
- Principal Investigator Email
- Stephanie.guidez@chu-poitiers.fr
- Contact Person Name
- Stephanie GUIDEZ
- Contact Person Email
- Stephanie.guidez@chu-poitiers.fr
- Site Name
- Hopital Saint Louis
- Department Name
- Hematology
- Principal Investigator Name
- Catherine THIEBLEMONT
- Principal Investigator Email
- catherine.thieblemont@aphp.fr
- Contact Person Name
- Catherine THIEBLEMONT
- Contact Person Email
- catherine.thieblemont@aphp.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 23-08-2024
- Latest Decision Or Authorization Date
- 13-08-2025
- Processing Time Days
- 355
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH
- Department Name
- Innere Medizin, Haematologie
- Principal Investigator Name
- Bernhard Heilmeier
- Principal Investigator Email
- bernhard.heilmeier@barmherzige-regensburg.de
- Contact Person Name
- Bernhard Heilmeier
- Contact Person Email
- bernhard.heilmeier@barmherzige-regensburg.de
- Site Name
- Gemeinschaftspraxis Haematologie Onkologie
- Department Name
- Haemato- Onkologie
- Principal Investigator Name
- Thomas Ilmer
- Principal Investigator Email
- buero@onkologie-dresden.net
- Contact Person Name
- Thomas Ilmer
- Contact Person Email
- buero@onkologie-dresden.net
- Site Name
- Klinikum Chemnitz gGmbH
- Department Name
- Klinik f. Innere Medizin III
- Principal Investigator Name
- Mathias Haenel
- Principal Investigator Email
- m.haenel@skc.de
- Contact Person Name
- Mathias Haenel
- Contact Person Email
- m.haenel@skc.de
Italy
- Earliest CTIS Part Ii Submission Date
- 03-09-2024
- Latest Decision Or Authorization Date
- 12-08-2025
- Processing Time Days
- 343
- Number Of Sites
- 4
- Number Of Participants
- 6
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- UO Oncologia medica e Ematologia
- Principal Investigator Name
- Armando Santoro
- Principal Investigator Email
- armando.santoro@cancercenter.humanitas.it
- Contact Person Name
- Armando Santoro
- Contact Person Email
- armando.santoro@cancercenter.humanitas.it
- Site Name
- Azienda Ospedaliera Policlinico Universitario Tor Vergata
- Department Name
- Ematologia e oncologia
- Principal Investigator Name
- Maria Christina Cox
- Principal Investigator Email
- mariacristina.cox@ptvonline.it
- Contact Person Name
- Maria Christina Cox
- Contact Person Email
- mariacristina.cox@ptvonline.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- UOC Ematologia
- 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
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- SC Ematologia Oncologia
- Principal Investigator Name
- Antonio Pinto
- Principal Investigator Email
- a.pinto@istitutotumori.a.it
- Contact Person Name
- Antonio Pinto
- Contact Person Email
- a.pinto@istitutotumori.a.it
Poland
- Earliest CTIS Part Ii Submission Date
- 27-08-2024
- Latest Decision Or Authorization Date
- 18-08-2025
- Processing Time Days
- 356
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Lux Med Onkologia Sp. z o.o.
- Department Name
- Oddział Hematoonkologii
- Principal Investigator Name
- Joanna Barankiewicz
- Principal Investigator Email
- joanna.barankiewicz@luxmed.pl
- Contact Person Name
- Joanna Barankiewicz
- Contact Person Email
- joanna.barankiewicz@luxmed.pl
- Site Name
- Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
- Department Name
- Klinika Hematologii
- Principal Investigator Name
- Jaroslaw Czyz
- Principal Investigator Email
- jczyz@onet.pl
- Contact Person Name
- Jaroslaw Czyz
- Contact Person Email
- jczyz@onet.pl
- Site Name
- Aidport Sp. z o.o.
- Principal Investigator Name
- Michal Kwiatek
- Principal Investigator Email
- michal.kwiatek@aidport.pl
- Contact Person Name
- Michal Kwiatek
- Contact Person Email
- michal.kwiatek@aidport.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 08-10-2025
- Processing Time Days
- 406
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Hematology
- Principal Investigator Name
- Sergio Ramos
- Principal Investigator Email
- sergio.ramos@quironsalud.com
- Contact Person Name
- Sergio Ramos
- Contact Person Email
- sergio.ramos@quironsalud.com
- Site Name
- Hospital Universitario Dr Peset Aleixandre
- Department Name
- Hematology
- Principal Investigator Name
- Eva María Donato Martín
- Principal Investigator Email
- donato_eva@gva.es
- Contact Person Name
- Eva María Donato Martín
- Contact Person Email
- donato_eva@gva.es
- Site Name
- University Hospital Son Espases
- Department Name
- 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
Sponsor
Primary sponsor
- Full Name
- Celgene Corp.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Yprime LLC
- Responsibilities
- Subject number assignment, treatment arm assignment, drug supply assignment
- Name
- Accenture Solutions Private Limited
- Responsibilities
- Embarc operations
- Name
- Accenture Services Pvt. Ltd.
- Responsibilities
- Pharmacovigilance duties: Medical review and Cases Data Entry
- Name
- Signant Health Global LLC
- Responsibilities
- PRO/COA
Third parties
- {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Sample storage","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Syngene International Limited","duties_or_roles":"T-cell phenotyping","organisation_type":"Pharmaceutical company"}
- {"country":"Singapore","full_name":"Labcorp Development (Asia) Pte Ltd","duties_or_roles":"Central Lab","organisation_type":"Pharmaceutical company"}
- {"country":"Japan","full_name":"Labcorp Development Japan K.K.","duties_or_roles":"Central Lab, Sample mgmt, Kit building, Storage and distribution of samples to other vendors","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"Subject number assignment, treatment arm assignment, drug supply assignment","organisation_type":"Non-Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"PRO/COA","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Services Pvt. Ltd.","duties_or_roles":"Pharmacovigilance duties: Medical review and Cases Data Entry","organisation_type":"SME"}
- {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"Routine clinical pathology testing, Clinical chemistry, Clinical haematology, Clinical microbiology, Histopathology","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Routine clinical pathology testing, Clinical chemistry, Clinical haematology, Clinical microbiology, Tumor blocks/slides storage, PGX spl, spl storage for vendors, IHC, Legacy LabCorp Central Lab","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Routine clinical pathology testing, Clinical chemistry, Clinical haematology, Clinical microbiology, IHC Biomarker expression analysis (PD-L1), other APH","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Golcadomide
- Active Substance
- GOLCADOMIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketed (prodAuthStatus: 1)
- Dose Levels
- Two dose levels planned (described in objectives as "two doses level").
- Maximum Dose
- Max daily dose listed 0.4 mg; max total dose listed 67.2 mg
- Combination Treatment
- Yes
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