Clinical trial • Phase III • Oncology|Haematology

GOLCADOMIDE for Follicular lymphoma | Relapsed/refractory follicular lymphoma

Phase III trial of GOLCADOMIDE for Follicular lymphoma | Relapsed/refractory follicular lymphoma.

Overview

Trial Therapeutic Area
Oncology|Haematology
Trial Disease
Follicular lymphoma | Relapsed/refractory follicular lymphoma
Trial Stage
Phase III
Drug Modality
Small molecule|Monoclonal antibody|Peptide/protein/enzyme
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
28-03-2025
First CTIS Authorization Date
18-07-2025

Trial design

Randomised, open-label, investigator’s choice: comparator regimens/options listed include rituximab (iv or subcutaneous; product entries include dosing information up to 375 mg/m2 iv or up to 1400 mg sc where specified), bendamustine hydrochloride (product entry lists dose units mg/m2; max daily amount 90 mg/m2), cyclophosphamide (mg/m2; max daily 750 mg/m2), lenalidomide (oral, up to 20 mg listed), prednisone/prednisolone (oral/iv, up to 100 mg listed), doxorubicin hydrochloride (infusion preparations listed), vincristine sulfate (iv, up to 2 mg). specific schedules/regimens are per investigator choice and are not fully specified in the ctis metadata.-controlled Phase III trial in Italy, Finland, Netherlands and others.

Randomised
Yes
Open Label
Yes
Comparator
Investigator’s Choice: comparator regimens/options listed include RITUXIMAB (IV or subcutaneous; product entries include dosing information up to 375 mg/m2 IV or up to 1400 mg SC where specified), BENDAMUSTINE HYDROCHLORIDE (product entry lists dose units mg/m2; max daily amount 90 mg/m2), CYCLOPHOSPHAMIDE (mg/m2; max daily 750 mg/m2), LENALIDOMIDE (oral, up to 20 mg listed), PREDNISONE/PREDNISOLONE (oral/IV, up to 100 mg listed), DOXORUBICIN HYDROCHLORIDE (infusion preparations listed), VINCRISTINE SULFATE (IV, up to 2 mg). Specific schedules/regimens are per investigator choice and are not fully specified in the CTIS metadata.
Target Sample Size
270

Eligibility

Recruits 270 adults.

Inclusion criteria

  • {"criterion_text":"- Participants over the age of 18\n- Participants meeting all inclusion criteria including disease characteristics, laboratory values and reproductive capacity status would be considered eligible."}

Exclusion criteria

  • {"criterion_text":"- Participants cannot participate to the study if they have 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\n- Other lymphoma subtypes\n- Specific allergies or adverse reactions to certain types of medication"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- To evaluate time from randomization to the first disease progression based on Lugano 2014 classification guidelines as assessed by Independent Review Adjudication committee (IRAC) or death from any cause, whichever occurs earlier.","definition_or_measurement_approach":"Time from randomization to first disease progression assessed per Lugano 2014 classification guidelines by an Independent Review Adjudication Committee (IRAC), or death from any cause; whichever occurs earlier."}

Secondary endpoints

  • {"endpoint_text":"- To evaluate how long a participant lives overall.","definition_or_measurement_approach":"Overall survival (OS): time from randomization to death from any cause."}
  • {"endpoint_text":"- To evaluate how well the cancer responds to the treatment.","definition_or_measurement_approach":"Overall response assessments (ORR) as determined by investigators and/or independent review (where specified)."}
  • {"endpoint_text":"- To evaluate how long the cancer responds.","definition_or_measurement_approach":"Duration of Response (DoR): time from first documented response to disease progression or death."}
  • {"endpoint_text":"- To evaluate how long it takes for participants to start a new treatment.","definition_or_measurement_approach":"Time to Next Anti-lymphoma Treatment (TTNT): time from randomization to initiation of a new anti-lymphoma therapy or death."}
  • {"endpoint_text":"- To evaluate how the treatment impacts the quality of life of participants while they are taking it.","definition_or_measurement_approach":"Patient-reported outcomes assessing symptoms, daily functioning and quality of life using validated questionnaires (per protocol statements)."}

Recruitment

Planned Sample Size
270
Recruitment Window Months
27
Consent Approach
Informed consent is obtained from adult participants (participants must be over 18). Subject information sheets and informed consent forms (ICFs) are provided; country-specific ICFs and participant information materials are available in multiple local languages (documents present for: English, Italian, French, Dutch, Spanish, Polish, Greek, German, Finnish). Pregnancy-specific participant/partner information and ICFs are included in the documentation set.

Geography

Total Number Of Sites
51
Total Number Of Participants
130

Italy

Earliest CTIS Part Ii Submission Date
16-05-2025
Latest Decision Or Authorization Date
29-07-2025
Processing Time Days
74
Number Of Sites
8
Number Of Participants
21

Sites

Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
ematologia
Contact Person Name
Gerardo Musuraca
Contact Person Email
Gerardo.musuraca@irst.emr.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
oncology
Contact Person Name
Carola Boccomini
Site Name
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Department Name
SCDU Ematolog ia
Contact Person Name
Marco Ladetto
Contact Person Email
marco.ladetto@ospedale.al.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
dipartimento malattie oncologiche ed ematologiche
Contact Person Name
Pier Luigi Zinzani
Contact Person Email
pierluigi.zinzani@unibo.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Clinical and experimental medicine
Contact Person Name
Sara Galimberti
Contact Person Email
sara.galimberti@unipi.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
UO Oncologia medica e Ematologia
Contact Person Name
Armando Santoro
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
SC Ematologia Oncologia
Contact Person Name
Antonio Pinto
Contact Person Email
a.pinto@istitutotumori.a.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino (duplicate entry may exist in dataset)

Finland

Earliest CTIS Part Ii Submission Date
24-06-2025
Latest Decision Or Authorization Date
18-07-2025
Processing Time Days
24
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
HUS-Yhtymae
Department Name
Comprehensive cancer center
Contact Person Name
Sirpa Leppä
Contact Person Email
sirpa.leppa@hus.fi
Site Name
Oulu University Hospital
Department Name
Cancer centre
Contact Person Name
Hanne Kuitunen
Contact Person Email
hanne.kuitunen@pohde.fi
Site Name
Turku University Hospital
Department Name
Department of Oncology and Radiotherapy, Oncology and hematology
Contact Person Name
Taina Reunamo
Contact Person Email
taina.reunamo@varha.fi

Netherlands

Earliest CTIS Part Ii Submission Date
07-07-2025
Latest Decision Or Authorization Date
18-07-2025
Processing Time Days
11
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Universitair Medisch Centrum Utrecht
Department Name
Hematology
Contact Person Name
Margot Jak
Contact Person Email
m.jak@umcutrecht.nl
Site Name
Amsterdam UMC Stichting
Department Name
Hematology
Contact Person Name
Sanne H. Tonino
Contact Person Email
hematology@amsterdamumc.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Hematology
Contact Person Name
Marcel Nijland
Contact Person Email
m.nijland@umcg.nl

Greece

Earliest CTIS Part Ii Submission Date
14-04-2025
Latest Decision Or Authorization Date
21-07-2025
Processing Time Days
98
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Department of Haematology
Contact Person Name
Niki Stavroyianni
Contact Person Email
niki.stavroyianni@gmail.com
Site Name
University General Hospital Of Ioannina
Department Name
Department of Haematology
Contact Person Name
Eleftheria Hatzimichael
Contact Person Email
ehatzim@uoi.gr
Site Name
University General Hospital Of Alexandroupoli
Department Name
Haematology Division, Thalassemia Unit
Contact Person Name
Ioannis Kotsianidis
Contact Person Email
ikotsian@med.duth.gr
Site Name
Laiko General Hospital Of Athens
Department Name
Department of Clinical Trials, Haematology Clinic and Bone Marrow Transplantation Unit
Contact Person Name
Theodoros Vassilakopoulos
Site Name
Evaggelismos Hospital
Department Name
Hematology and Lymphoma Clinic
Contact Person Name
Maria Bouzani
Contact Person Email
mbouzani@yahoo.com

Poland

Earliest CTIS Part Ii Submission Date
20-06-2025
Latest Decision Or Authorization Date
20-07-2025
Processing Time Days
30
Number Of Sites
5
Number Of Participants
13

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Układu Chłonnego
Contact Person Name
Ewa Paszkiewicz-Kozik
Site Name
Narodowy Instytut Onkologii i Traumatologii im. M. Kopernika w Lodzi
Department Name
Oddział Hematoonkologii z Pododdziałem Chemioterapii Dziennej
Contact Person Name
Joanna Góra-Tybor
Contact Person Email
jm.gora-tybor@kopernik.lodz.pl
Site Name
Pratia S.A.
Department Name
Pratia MCM Krakow
Contact Person Name
Wojciech Jurczak
Contact Person Email
wojciech.jurczak@pratia.com
Site Name
Szpitale Pomorskie Sp. z o.o.
Department Name
Szpital Morski im. PCK Oddział Hematologii i Transplantologii Szpiku
Contact Person Name
Adam Witkowski
Site Name
Aidport Sp. z o.o.
Contact Person Name
Michał Kwiatek
Contact Person Email
michal.kwiatek@aidport.pl

France

Earliest CTIS Part Ii Submission Date
13-05-2025
Latest Decision Or Authorization Date
18-07-2025
Processing Time Days
66
Number Of Sites
8
Number Of Participants
20

Sites

Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Hematologie
Contact Person Name
Loic YSEBAERT
Contact Person Email
ysebaert.loic@iuct-oncopole.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hematologie clinique
Contact Person Name
Thomas GASTINNE
Contact Person Email
thomas.gastinne@chu-nantes.fr
Site Name
Institut Curie
Department Name
Oncologie
Contact Person Name
Clementine SARKOZY
Contact Person Email
clementine.sarkozy@curie.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Hematologie clinique
Contact Person Name
Guillaume CARTRON
Contact Person Email
g-cartron@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hematologie clinique et therapie cellulaire
Contact Person Name
Francois-Xavier GROS
Site Name
Hospices Civils De Lyon
Department Name
Hematologie
Contact Person Name
Emmanuel BACHY
Contact Person Email
emmanuel.bachy@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Services des maladies du sang
Contact Person Name
Franck MORSCHHAUSER
Site Name
Hopital Saint Louis
Department Name
Hemato-oncoloige
Contact Person Name
Catherine THIEBLEMONT
Contact Person Email
catherine.thieblemont@aphp.fr

Germany

Earliest CTIS Part Ii Submission Date
30-06-2025
Latest Decision Or Authorization Date
18-07-2025
Processing Time Days
18
Number Of Sites
13
Number Of Participants
25

Sites

Site Name
HELIOS Klinikum Erfurt GmbH
Department Name
4. Medizinische Klinik
Contact Person Name
Sebastian Scholl
Site Name
Klinikum Chemnitz gGmbH
Department Name
Innere Medizin III
Contact Person Name
Mathias Hänel
Contact Person Email
m.haenel@skc.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Innere Medizin II
Contact Person Name
Ulf Schnetzke
Contact Person Email
ulf.schnetzke@med.uni-jena.de
Site Name
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie
Department Name
Gemeinschaftspraxis für Hämatologie und Onkologie Münster
Contact Person Name
Rüdiger Liersch
Contact Person Email
liersch@onkologie-muenster.de
Site Name
Universitaetsklinikum Augsburg
Department Name
II. Medizinische Klinik
Contact Person Name
Rainer Claus
Contact Person Email
rainer.claus@uk-augsburg.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Institute of Experimental Cancer Research Comprehensive Cancer Center Ulm (CCCU)
Contact Person Name
Christian Buske
Contact Person Email
christian.buske@uni-ulm.de
Site Name
Gemeinschaftspraxis Haematologie Onkologie
Department Name
Onkologische Schwerpunktpraxis
Contact Person Name
Thomas Illmer
Contact Person Email
illmer@onkologie-dresden.net
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Medizinische Klinik und Poliklinik II
Contact Person Name
Johannes Düll
Contact Person Email
duell_j@ukw.de
Site Name
LMU Klinikum Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik III
Contact Person Name
Martin Dreyling
Site Name
GEFOS Gesellschaft fuer onkologische Studien Dortmund mbH
Department Name
Gemeinschaftspraxis für Hämatologie und Onkologie
Contact Person Name
Sandra Ketzler-Henkel
Contact Person Email
ketzler@onkologie-dortmund.de
Site Name
Studienzentrum am Raschplatz
Contact Person Name
Eyck von der Heyde
Site Name
Universitaet Des Saarlandes
Department Name
Klinik für Innere Medizin I
Contact Person Name
Philipp Staber
Contact Person Email
philipp.staber@uks.eu
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Hämatologie, Onkologie und Klinische Immunilogie
Contact Person Name
Nora Liebers

Spain

Earliest CTIS Part Ii Submission Date
29-05-2025
Latest Decision Or Authorization Date
22-07-2025
Processing Time Days
54
Number Of Sites
6
Number Of Participants
18

Sites

Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Hematology
Contact Person Name
Sonia González de Villambrosia
Site Name
Parc Tauli Hospital Universitari
Department Name
Hematology
Contact Person Name
Xavier Vilaseca Creus
Contact Person Email
xvilaseca@tauli.cat
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Hematology
Contact Person Name
Blanca Ferrer Lores
Contact Person Email
ferrer_blalor@gva.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Hematology
Contact Person Name
Sergio Ramos Cillán
Contact Person Email
sergio.ramosc@quironsalud.com
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Hematology
Contact Person Name
José Puerta Puerta
Contact Person Email
XXXXXX@XXXXXX.XXXX
Site Name
Hospital Universitario Infanta Leonor
Department Name
Hematology
Contact Person Name
José Ángel Hernández Rivas
Contact Person Email
jahernandezr@salud.madrid.org

Sponsor

Primary sponsor

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

Contract research organisations

Name
Clario
Responsibilities
Medical image analysis/ review - X-ray, MRI, ultrasound, etc., imaging
Name
QPS LLC
Responsibilities
Sample analysis and sample managemen
Name
Cerba Research
Responsibilities
Routine clinical pathology testing, clinical chemistry, clinical hematology, clinical microbiology, histopathology, central lab, sample management
Name
Endpoint Clinical Inc.
Responsibilities
Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment
Name
Iqvia Inc.
Responsibilities
SUSAR reporting, site payments and multiple operational trial management functions
Name
Signant Health Global LLC
Responsibilities
IVRS – treatment randomisation, PRO/COA management, tablet procurement and supply

Third parties

  • {"country":"United States","full_name":"Clario","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc., imaging","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translation Services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"QPS LLC","duties_or_roles":"Sample analysis and sample managemen","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"Routine clinical pathology testing, clinical chemistry, clinical hematology, clinical microbiology, histopathology, central lab, sample management","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Provides electronic payments, travel arrangements, electronic study-related comunications to patients, Reimbursements","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"IVRS – treatment randomisation, PRO/COA management, tablet procurement and supply","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":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"SUSAR reporting, site payments and other data and trial management functions (multiple operational responsibilities)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Golcadomide
Active Substance
GOLCADOMIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Orphan Designation
Yes
Starting Dose
0.4 mg (max daily dose listed 0.4 mg)
Maximum Dose
0.4 mg (max daily dose)
Combination Treatment
Yes

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