Register a trial

Please note that the ANZCTR will be unattended on Friday 25th April due to the ANZAC Day public holiday. Submissions and updates will not be processed during that time.

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.



Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06911502




Registration number
NCT06911502
Ethics application status
Date submitted
28/03/2025
Date registered
4/04/2025

Titles & IDs
Public title
A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Choice in Participants With Relapsed/Refractory Follicular Lymphoma (GOLSEEK-4)
Scientific title
A Phase 3, Multicenter, Randomized, Open Label Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) Vs Investigator's Choice in Participants With Relapsed/Refractory Follicular Lymphoma
Secondary ID [1] 0 0
2024-519152-82
Secondary ID [2] 0 0
CA073-1003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Golcadomide
Treatment: Drugs - Rituximab
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Vincristine
Treatment: Drugs - Prednisone/Prednisolone
Treatment: Drugs - Bendamustine

Experimental: Golcadomide + Rituximab -

Active comparator: Rituximab + Lenalidomide/Chemotherapy - Rituximab + Lenalidomide or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone) or Rituximab + Bendamustine


Treatment: Drugs: Golcadomide
Specified dose on specified days

Treatment: Drugs: Rituximab
Specified dose on specified days

Treatment: Drugs: Lenalidomide
Specified dose on specified days

Treatment: Drugs: Cyclophosphamide
Specified dose on specified days

Treatment: Drugs: Doxorubicin
Specified dose on specified days

Treatment: Drugs: Vincristine
Specified dose on specified days

Treatment: Drugs: Prednisone/Prednisolone
Specified dose on specified days

Treatment: Drugs: Bendamustine
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression free survival (PFS) assessed by Independent Review Adjudication committee (IRAC)
Timepoint [1] 0 0
Up to approximately 32 Months
Secondary outcome [1] 0 0
Overall response rate (ORR) assessed by IRAC
Timepoint [1] 0 0
Up to approximately 32 Months
Secondary outcome [2] 0 0
Overall survival (OS)
Timepoint [2] 0 0
Up to approximately 83 Months
Secondary outcome [3] 0 0
PFS as assessed by investigator
Timepoint [3] 0 0
Up to approximately 32 Months
Secondary outcome [4] 0 0
ORR as assessed by investigator
Timepoint [4] 0 0
Up to approximately 32 Months
Secondary outcome [5] 0 0
Number of participants who achieve complete metabolic response (CMR)
Timepoint [5] 0 0
Up to approximately 32 Months
Secondary outcome [6] 0 0
Duration of Response (DoR)
Timepoint [6] 0 0
Up to approximately 32 Months
Secondary outcome [7] 0 0
Event free survival (EFS)
Timepoint [7] 0 0
Up to approximately 32 Months
Secondary outcome [8] 0 0
Time to next anti-lymphoma treatment (TTNT)
Timepoint [8] 0 0
Up to approximately 32 Months
Secondary outcome [9] 0 0
PFS on next anti-lymphoma treatment (PFS2)
Timepoint [9] 0 0
Up to approximately 32 Months
Secondary outcome [10] 0 0
Time from randomization to meaningful improvement in primary domains of interest in the European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) Questionnaire
Timepoint [10] 0 0
Up to approximately 32 Months
Secondary outcome [11] 0 0
Time from randomization to meaningful improvement in primary domains of interest in the European Organization for Research and Treatment of Cancer - Non- Hodgkin Lymphoma- Low Grade- 20 items (EORTC QLQNHL- LG20) Questionnaire
Timepoint [11] 0 0
Up to approximately 32 Months
Secondary outcome [12] 0 0
Minimal residual disease (MRD) negativity
Timepoint [12] 0 0
Up to approximately 32 Months

Eligibility
Key inclusion criteria
* Participant has histologically confirmed FL (Grade 1, 2, or 3a) as assessed by local pathology. Adequate fresh tumor biopsy tissue or archived tumor biopsy from the latest relapse if available with corresponding pathology report for retrospective central pathology confirmation of relapse, is required. Evaluation from fine needle aspirate is not permitted.
* Relapsed or refractory disease:

1. Relapsed FL is defined as relapse after an initial response of CR or PR to the most recent prior therapy.
2. Refractory FL is defined as best response of SD or PD to the most recent prior therapy.
* Eastern Cooperative Oncology Group (ECOG) 0-2 (ECOG 3 authorized if it is due to lymphoma and not comorbidities).
* Participant must have positron emission tomography (PET)-positive disease with at least one PET-positive lesion and measurable disease on cross section imaging by CT, as defined by Lugano classification.
* Participants with an indication for anti-lymphoma treatment as per investigator assessment based on modified Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria.
* Participant has received at least 1 or more prior lines of systemic therapy with one line consisting of a combination including an anti-CD20 monoclonal antibody (eg, rituximab, obinutuzumab) and an alkylating agent (eg, cyclophosphamide, bendamustine). Prior treatment with radiation therapy does not count as a line of therapy for eligibility.
* Lab parameters:

1. Absolute neutrophil count (ANC) = 1,000 cells/mm3 (1.0 x 109 /L),
2. PLT count = 75,000 cells/mm3 (75 x 109 /L)
3. Hb = 7.5 g/dL
* estimated glomerular filtration rate (eGFR) = 30 ml/min/1.73m².
* Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) = 2.5 x upper limit of normal (ULN). In case of documented liver involvement by lymphoma, ALT/SGPT and AST/SGOT must be = 5.0× ULN.
* Serum total bilirubin = 1.5 × ULN (corresponding to mild dysfunction as per National Cancer Institute Organ Dysfunction Working Group [NCI ODWG] criteria). In case of documented liver involvement by lymphoma, serum total bilirubin must be = 3.0 × ULN (corresponding to moderate dysfunction as per NCI ODWG criteria). For cases of Gilberts syndrome, serum total bilirubin= 5.0 × ULN
* Adequate cardiac function for participants receiving anthracycline-based chemotherapy, defined as left ventricular ejection fraction (LVEF) = 40% as assessed by echocardiogram (ECHO) as standard of care or multi-gated acquisition scan (MUGA)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL or of transformed Non-Hodgkin Lymphoma (NHL) or any other indolent lymphoma.
* Follicular large cell as per 5th World Health Organization (WHO) sub-classification (grade 3b FL per WHO 4th classification) or duodenal-type FL.
* Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from compliantly participating in the study based on Investigator's judgment.
* Participant has any condition that confounds the ability to interpret data from the study based on Investigator's or Sponsor's judgment.
* Presence or history of central nervous system (CNS) involvement by lymphoma.
* History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
* Deep venous thrombosis/Pulmonary embolism within 1 month prior to enrollment.
* Participants with a history of progressive multifocal leukoencephalopathy.
* Participant has any other subtype of lymphoma.
* Participant has persistent diarrhea or malabsorption = Grade 2 (NCI CTCAE v5.0), despite medical management.
* History of another primary malignancy that has not been in remission for = 3 years except for non-invasive malignancies.
* Participants who are refractory to both chemotherapies as well as lenalidomide, defined as:

1. SD/progressive disease as best response to CHOP and Bendamustine based immunochemotherapy or a response to CHOP and Bendamustine based immunochemotherapy that lasted less than 6 months AND
2. SD/progressive disease as best response to lenalidomide based regimen or a response to lenalidomide based regimen that lasted less than 6 months.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
8/07/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2030
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0134 - Westmead
Recruitment hospital [2] 0 0
Local Institution - 0132 - Adelaide
Recruitment hospital [3] 0 0
Local Institution - 0131 - Hobart
Recruitment hospital [4] 0 0
Local Institution - 0128 - Heidelberg
Recruitment hospital [5] 0 0
Local Institution - 0198 - Malvern
Recruitment hospital [6] 0 0
Local Institution - 0127 - Perth
Recruitment hospital [7] 0 0
Local Institution - 0224 - Perth
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
5042 - Adelaide
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3144 - Malvern
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
Rhode Island
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Brazil
State/province [16] 0 0
Espírito Santo
Country [17] 0 0
Brazil
State/province [17] 0 0
Rio De Janeiro
Country [18] 0 0
Brazil
State/province [18] 0 0
Rio Grande Do Sul
Country [19] 0 0
Brazil
State/province [19] 0 0
São Paulo
Country [20] 0 0
Brazil
State/province [20] 0 0
Rio de Janeiro
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Chile
State/province [24] 0 0
Región Metropolitana De Santiago
Country [25] 0 0
Finland
State/province [25] 0 0
Pohjois-Pohjanmaa
Country [26] 0 0
Finland
State/province [26] 0 0
Varsinais-Suomi
Country [27] 0 0
Finland
State/province [27] 0 0
Helsinki
Country [28] 0 0
France
State/province [28] 0 0
Aquitaine
Country [29] 0 0
France
State/province [29] 0 0
Haute-Garonne
Country [30] 0 0
France
State/province [30] 0 0
Hauts-de-Seine
Country [31] 0 0
France
State/province [31] 0 0
Hérault
Country [32] 0 0
France
State/province [32] 0 0
Loire-Atlantique
Country [33] 0 0
France
State/province [33] 0 0
Nord
Country [34] 0 0
France
State/province [34] 0 0
Rhône
Country [35] 0 0
France
State/province [35] 0 0
Paris
Country [36] 0 0
Germany
State/province [36] 0 0
Baden-Württemberg
Country [37] 0 0
Germany
State/province [37] 0 0
Bayern
Country [38] 0 0
Germany
State/province [38] 0 0
Niedersachsen
Country [39] 0 0
Germany
State/province [39] 0 0
Nordrhein-Westfalen
Country [40] 0 0
Germany
State/province [40] 0 0
Saarland
Country [41] 0 0
Germany
State/province [41] 0 0
Sachsen
Country [42] 0 0
Germany
State/province [42] 0 0
Thüringen
Country [43] 0 0
Germany
State/province [43] 0 0
Dresden
Country [44] 0 0
Germany
State/province [44] 0 0
München
Country [45] 0 0
Germany
State/province [45] 0 0
Wuerzburg
Country [46] 0 0
Greece
State/province [46] 0 0
Attikí
Country [47] 0 0
Greece
State/province [47] 0 0
Thessaloníki
Country [48] 0 0
Greece
State/province [48] 0 0
Alexandroupolis
Country [49] 0 0
Greece
State/province [49] 0 0
Ípeiros
Country [50] 0 0
India
State/province [50] 0 0
Delhi
Country [51] 0 0
India
State/province [51] 0 0
Karnataka
Country [52] 0 0
India
State/province [52] 0 0
Maharashtra
Country [53] 0 0
India
State/province [53] 0 0
Telangana
Country [54] 0 0
Italy
State/province [54] 0 0
Emilia-Romagna
Country [55] 0 0
Italy
State/province [55] 0 0
Milano
Country [56] 0 0
Italy
State/province [56] 0 0
Toscana
Country [57] 0 0
Italy
State/province [57] 0 0
Alessandria
Country [58] 0 0
Italy
State/province [58] 0 0
Napoli
Country [59] 0 0
Italy
State/province [59] 0 0
Torino
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Seoul-teukbyeolsi [Seoul]
Country [61] 0 0
Netherlands
State/province [61] 0 0
Noord-Holland
Country [62] 0 0
Netherlands
State/province [62] 0 0
Groningen
Country [63] 0 0
Netherlands
State/province [63] 0 0
Utrecht
Country [64] 0 0
Poland
State/province [64] 0 0
Mazowieckie
Country [65] 0 0
Poland
State/province [65] 0 0
Malopolskie
Country [66] 0 0
Poland
State/province [66] 0 0
Pomorskie
Country [67] 0 0
Poland
State/province [67] 0 0
Wielkopolskie
Country [68] 0 0
Poland
State/province [68] 0 0
Lódzkie
Country [69] 0 0
Saudi Arabia
State/province [69] 0 0
Ash Sharqiyah
Country [70] 0 0
Saudi Arabia
State/province [70] 0 0
Riyadh
Country [71] 0 0
Spain
State/province [71] 0 0
Barcelona [Barcelona]
Country [72] 0 0
Spain
State/province [72] 0 0
Cantabria
Country [73] 0 0
Spain
State/province [73] 0 0
Madrid, Comunidad De
Country [74] 0 0
Spain
State/province [74] 0 0
Valenciana, Comunitat
Country [75] 0 0
Spain
State/province [75] 0 0
Granada
Country [76] 0 0
Spain
State/province [76] 0 0
Madrid
Country [77] 0 0
Turkey
State/province [77] 0 0
Istanbul
Country [78] 0 0
Turkey
State/province [78] 0 0
Ankara
Country [79] 0 0
Turkey
State/province [79] 0 0
Antalya
Country [80] 0 0
Turkey
State/province [80] 0 0
Mersin
Country [81] 0 0
United Kingdom
State/province [81] 0 0
England
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Kent
Country [83] 0 0
United Kingdom
State/province [83] 0 0
London, City Of
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Address 0 0
Country 0 0
Phone 0 0
8559073286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06911502