Clinical trial • Phase I/II • Oncology
GOLCADOMIDE for Follicular B-cell non-Hodgkin's lymphoma | Primary central nervous system lymphoma | Marginal zone lymphoma | Diffuse large B-cell lymphoma | Mantle cell lymphoma
Phase I/II trial of GOLCADOMIDE for Follicular B-cell non-Hodgkin's lymphoma | Primary central nervous system lymphoma | Marginal zone lymphoma | Diffuse…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Follicular B-cell non-Hodgkin's lymphoma | Primary central nervous system lymphoma | Marginal zone lymphoma | Diffuse large B-cell lymphoma | Mantle cell lymphoma
- Trial Stage
- Phase I/II
- Drug Modality
- Small molecule | Monoclonal antibody
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 25-07-2024
- First CTIS Authorization Date
- 23-09-2024
Trial design
Randomised, open-label, valemetostat tosylate (oral film-coated tablet) — dose/schedule not specified-controlled, adaptive Phase I/II trial in Denmark, France, Spain and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Valemetostat Tosylate (oral film-coated tablet) — dose/schedule not specified
- Adaptive
- True, includes dose-escalation design with DLT evaluation period to define Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D); multiple combination cohorts and cohort expansions described.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 234
Eligibility
Recruits 234 No vulnerable population selected. Subjects must be ≥18 years and provide informed consent. No paediatric/assent provisions are described..
- Pregnancy Exclusion
- Agree to follow the CC-99282 Pregnancy Prevention Plan (PPP)
- Vulnerable Population
- No vulnerable population selected. Subjects must be ≥18 years and provide informed consent. No paediatric/assent provisions are described.
Inclusion criteria
- {"criterion_text":"- Subject is ≥18 years of age at the time of signing the informed consent form (ICF).\n- Subject has a history of NHL (including DLBCL, FL, MZL, MCL and PCNSL) with relapsed or refractory disease\n- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n- Subjects must have the following laboratory values: a. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L or ≥ 1 x 10^9/L in case of documented bone marrow involvement, without growth factor support for 7 days (14 days if pegfilgastrim) b. Hemoglobin (Hgb) ≥ 8 g/dL c. Platelets (plt) ≥ 75 x 10^9/L or ≥ 50 x 10^9/L in case of documented bone marrow involvement, without transfusion for 7 days d. Serum bilirubin ≤ 1.5 x ULN (upper limit of normal). e. AST/SGOT and ALT/SGPT ≤ 2.5X ULN f. Estimated serum creatinine clearance of > 30 mL/min using the Cockcroft-Gault equation or directly determined from the 24-hour urine collection method or using the modification of diet in renal disease (MDRD) formula. For Cohort G and H, estimated serum creatinine clearance of ≥ 45 mL/min using the Cockcroft-Gault equation or directly determined from the 24-hour urine collection method or using the modification of diet in renal disease (MDRD) formula.\n- Agree to follow the CC-99282 Pregnancy Prevention Plan (PPP)"}
Exclusion criteria
- {"criterion_text":"- Subject has life expectancy ≤ 2 months.\n- Subjects who have aggressive lymphoma relapse requiring immediate cytoreductive therapy to avoid potential life-threatening consequences (eg, due to tumor location).\n- Subject has received prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to starting investigational product(s), whichever is shorter.\n- Subject has symptomatic CNS involvement of disease (does not apply to PCNSL subjects in Part B).\n- Subject is on chronic systemic immunosuppressive therapy or corticosteroids (eg, prednisone or equivalent not to exceed 10 mg per day within the last 14 days) or subjects with clinically significant graft versus- host disease (GVHD).\n- Subject had prior autologous SCT ≤ 3 months prior to starting investigational product(s) and any treatment-related toxicity is unresolved (grade > 1).\n- Subject had prior allogeneic SCT with either standard or reduced intensity conditioning ≤ 6 months prior to starting investigational product(s) and any treatment-related toxicity is unresolved (grade > 1)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- AEs including treatment-emergent adverse events (TEAEs), laboratory assessments, vital signs, ECG results, ECOG performance status, LVEF assessments, and physical examinations.","definition_or_measurement_approach":"Safety assessments including monitoring and recording AEs/TEAEs, laboratory tests, vital signs, ECGs, ECOG performance status, LVEF assessments and physical examinations."}
- {"endpoint_text":"- Recommended Phase 2 Dose (RP2D) and dosing Schedule(s): Dose limiting toxicities (DLTs), and Maximum Tolerated Dose (MTD) during the DLT evaluation period; establish the RP2D and optimal schedule of CC-99282 as monotherapy and in combination with rituximab obinutuzumab, tafasitamab or valemetostat ± rituximab.","definition_or_measurement_approach":"DLT evaluation during the defined DLT assessment period to determine MTD and establish RP2D and optimal dosing schedules for monotherapy and combination regimens."}
Secondary endpoints
- {"endpoint_text":"- Preliminary efficacy: Determined by the Lugano Classification for NHL response criteria including: Objective response rate (ORR), any complete response (CR) or partial response (PR) as best response; Time to response (TTR); Duration of response (DoR); Progression free survival (PFS) and overall survival (OS); Additional DOR, PFS and OS for subjects treated for 6 cycles with CC-99282 + rituximab who discontinue due to achieving CR (Cohort I)","definition_or_measurement_approach":"Efficacy assessed using Lugano Classification for NHL response (ORR, CR, PR), TTR, DoR, PFS, OS; subgroup analyses including subjects treated for 6 cycles with CC-99282 + rituximab (Cohort I)."}
- {"endpoint_text":"- Preliminary efficacy in PCNSL: Determined using the modified International PCNSL Collaborative Group (IPCG) criteria including: Objective response rate (ORR); Time to response (TTR); Duration of response (DoR); Progression free survival (PFS) and overall survival (OS)","definition_or_measurement_approach":"Efficacy in PCNSL assessed using modified IPCG criteria (ORR, TTR, DoR, PFS, OS)."}
Recruitment
- Planned Sample Size
- 234
- Recruitment Window Months
- 95
- Consent Approach
- Informed consent obtained from participants (subjects ≥18). Subject Information Sheets and Informed Consent Forms are available in multiple country-specific languages (English, French, Spanish, Italian). Pregnancy-related information and a Pregnancy Prevention Plan are provided; partner/pregnant participant information/ICF documents exist.
Geography
- Total Number Of Sites
- 23
- Total Number Of Participants
- 204
Denmark
- Earliest CTIS Part Ii Submission Date
- 14-08-2024
- Latest Decision Or Authorization Date
- 25-06-2025
- Processing Time Days
- 315
- Number Of Sites
- 3
- Number Of Participants
- 27
Sites
- Site Name
- Sygehus Lillebaelt Vejle Sygehus
- Department Name
- Department of Hematology
- Principal Investigator Name
- Michael Clausen
- Principal Investigator Email
- michael.roost.clausen@rsyd
- Contact Person Name
- Michael Clausen
- Contact Person Email
- michael.roost.clausen@rsyd
- Site Name
- Aarhus Universitetshospital
- Department Name
- Department of Hematology
- Principal Investigator Name
- Judit Jørgensen
- Principal Investigator Email
- judijoer@rm.dk
- Contact Person Name
- Judit Jørgensen
- Contact Person Email
- judijoer@rm.dk
- Site Name
- Rigshospitalet
- Department Name
- Hematology
- Principal Investigator Name
- Anna Caroline Riley
- Principal Investigator Email
- anna.caroline.riley@regionh.dk
- Contact Person Name
- Anna Caroline Riley
- Contact Person Email
- anna.caroline.riley@regionh.dk
France
- Earliest CTIS Part Ii Submission Date
- 14-08-2024
- Latest Decision Or Authorization Date
- 25-06-2025
- Processing Time Days
- 315
- Number Of Sites
- 9
- Number Of Participants
- 115
Sites
- Site Name
- Oncopole Claudius Regaud
- Department Name
- IUCT Oncopole
- Principal Investigator Name
- Pierre Bories
- Principal Investigator Email
- bories.pierre@iuct-oncopole.fr
- Contact Person Name
- Pierre Bories
- Contact Person Email
- bories.pierre@iuct-oncopole.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- 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
- Assistance Publique Hopitaux De Paris
- Department Name
- Hematology
- Principal Investigator Name
- Catherine Thieblement
- Principal Investigator Email
- catherine.thieblemont@aphp.fr
- Contact Person Name
- Catherine Thieblement
- Contact Person Email
- catherine.thieblemont@aphp.fr
- Site Name
- Institut Bergonie
- Department Name
- Hematology
- Principal Investigator Name
- Fontanet Bijou
- Principal Investigator Email
- f.bijou@bordeaux.unicancer.fr
- Contact Person Name
- Fontanet Bijou
- Contact Person Email
- f.bijou@bordeaux.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- early therapeutic innovation
- Principal Investigator Name
- Vincent Ribrag
- Principal Investigator Email
- vincent.ribrag@gustaveroussy.fr
- Contact Person Name
- Vincent Ribrag
- Contact Person Email
- vincent.ribrag@gustaveroussy.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Clinical Hematology
- Principal Investigator Name
- Guillaume Cartron
- Principal Investigator Email
- g-cartron@chu-montpellier.fr
- Contact Person Name
- Guillaume Cartron
- Contact Person Email
- g-cartron@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Blood disease
- 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 Henri Becquerel
- Department Name
- Oncology
- Principal Investigator Name
- Fabrice Jardin
- Principal Investigator Email
- fabrice.jardin@chb.unicancer.fr
- Contact Person Name
- Fabrice Jardin
- Contact Person Email
- fabrice.jardin@chb.unicancer.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- 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
Spain
- Earliest CTIS Part Ii Submission Date
- 14-08-2024
- Latest Decision Or Authorization Date
- 26-06-2025
- Processing Time Days
- 316
- Number Of Sites
- 6
- Number Of Participants
- 34
Sites
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Oncologia
- Principal Investigator Name
- Norma Gutierrez
- Principal Investigator Email
- normagu@usal.es
- Contact Person Name
- Norma Gutierrez
- Contact Person Email
- normagu@usal.es
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Oncologia
- Principal Investigator Name
- Antonio Rueda-Dominaguez
- Principal Investigator Email
- rueda.dominguez@gmail.com
- Contact Person Name
- Antonio Rueda-Dominaguez
- Contact Person Email
- rueda.dominguez@gmail.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncologia
- Principal Investigator Name
- Laura Abril
- Principal Investigator Email
- labril@iconcologia.net
- Contact Person Name
- Laura Abril
- Contact Person Email
- labril@iconcologia.net
- Site Name
- Hospital Universitario La Paz
- Department Name
- Oncologia
- Principal Investigator Name
- Pilar Gomez
- Principal Investigator Email
- pilargp84@gmail.com
- Contact Person Name
- Pilar Gomez
- Contact Person Email
- pilargp84@gmail.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncologia
- Principal Investigator Name
- Daniel Morillo
- Principal Investigator Email
- dmorillo@startmadrid.com
- Contact Person Name
- Daniel Morillo
- Contact Person Email
- dmorillo@startmadrid.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncologia
- Principal Investigator Name
- Cecilia Carpio
- Principal Investigator Email
- ccarpio@vhio.net
- Contact Person Name
- Cecilia Carpio
- Contact Person Email
- ccarpio@vhio.net
Italy
- Earliest CTIS Part Ii Submission Date
- 14-08-2024
- Latest Decision Or Authorization Date
- 12-11-2025
- Processing Time Days
- 455
- Number Of Sites
- 5
- Number Of Participants
- 28
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Dipartimento Malattie Oncologiche ed ematologiche
- Principal Investigator Name
- Vittorio Stefani
- Principal Investigator Email
- vittorio.stefoni2@unibo.it
- Contact Person Name
- Vittorio Stefani
- Contact Person Email
- vittorio.stefoni2@unibo.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- S.C. Ematologia Oncologica
- Principal Investigator Name
- Silvia Ferrari
- Principal Investigator Email
- s.ferrari@asst-pg23.it
- Contact Person Name
- Silvia Ferrari
- Contact Person Email
- s.ferrari@asst-pg23.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- UOC Ematologia I
- Principal Investigator Name
- Luca Arcaini
- Principal Investigator Email
- l.arcaini@smatteo.pv.it
- Contact Person Name
- Luca Arcaini
- Contact Person Email
- l.arcaini@smatteo.pv.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- SC Ematologia
- Principal Investigator Name
- Antonio Pinto
- Principal Investigator Email
- a.pinto@istitutotumori.na.it
- Contact Person Name
- Antonio Pinto
- Contact Person Email
- a.pinto@istitutotumori.na.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Dipartimento Ematologia, Oncologia e Medicina Molecolare
- Principal Investigator Name
- Erika Ravelli
- Principal Investigator Email
- erika.ravelli@ospedaleniguarda.it
- Contact Person Name
- Erika Ravelli
- Contact Person Email
- erika.ravelli@ospedaleniguarda.it
Sponsor
Primary sponsor
- Full Name
- Celgene Corp.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- Programming (and other sponsor duties indicated by codes 10, 11, 6)
- Name
- Endpoint Clinical Inc.
- Responsibilities
- IVRS30 – treatment randomization
- Name
- QPS LLC
- Responsibilities
- TCR clonality
Third parties
- {"country":"United States","full_name":"QPS LLC","duties_or_roles":"TCR clonality","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Myriad RBM Inc.","duties_or_roles":"ex vivo T-Cell stimulation analysis","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"database, kits, logistics, management, storage","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"IVRS30 – treatment randomization","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Programming (plus other duties indicated by sponsor duty codes 10,11,6)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Golcadomide
- Active Substance
- GOLCADOMIDE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- 1
- Investigational Product Name
- Valemetostat Tosylate
- Active Substance
- VALEMETOSTAT TOSILATE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- 1
- Orphan Designation
- Yes
- Investigational Product Name
- RITUXIMAB
- Active Substance
- RITUXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- 2
- Combination Treatment
- Yes
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