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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06425302




Registration number
NCT06425302
Ethics application status
Date submitted
17/05/2024
Date registered
22/05/2024

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma
Scientific title
A Phase 2 Randomized, Open Label Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma
Secondary ID [1] 0 0
U1111-1303-4594
Secondary ID [2] 0 0
CA073-1022
Universal Trial Number (UTN)
Trial acronym
GOLSEEK-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma, Follicular 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 - Cyclophosphamide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Vincristine
Treatment: Drugs - Prednisone
Treatment: Drugs - Bendamustine

Experimental: Rituximab + Chemotherapy - R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine

Experimental: Golcadomide Dose 1 + Rituximab -

Experimental: Golcadomide Dose 2 + Rituximab -


Treatment: Drugs: Golcadomide
Specified dose on specified days

Treatment: Drugs: Rituximab
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
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
Number of participants who achieve complete metabolic response (CMR) as assessed by Lugano criteria 2014
Timepoint [1] 0 0
Up to approximately 12 months from participant randomization
Secondary outcome [1] 0 0
Number of participants with Adverse Events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria, v.5.0
Timepoint [1] 0 0
Up to 28 days after last dose
Secondary outcome [2] 0 0
Number of participants with Treatment-emergent AEs (TEAEs) as assessed by the NCI CTCAE criteria, v.5.0
Timepoint [2] 0 0
Up to 28 days after last dose
Secondary outcome [3] 0 0
Best Overall Response (OR)
Timepoint [3] 0 0
Up to approximately 12 months from participant randomization
Secondary outcome [4] 0 0
Duration of Response (DoR)
Timepoint [4] 0 0
Up to approximately 3 years after randomization of the last participant
Secondary outcome [5] 0 0
Complete Response at 30 months (CR30)
Timepoint [5] 0 0
At approximately 30 months from randomization
Secondary outcome [6] 0 0
Complete Metabolic Response at 6 months from the randomization (CMR6)
Timepoint [6] 0 0
At approximately 6 months from randomization
Secondary outcome [7] 0 0
Complete Metabolic Response at 12 months from the randomization (CMR12)
Timepoint [7] 0 0
At approximately 12 months from randomization
Secondary outcome [8] 0 0
Progression Free Survival (PFS)
Timepoint [8] 0 0
Up to approximately 3 years from randomization of last participant
Secondary outcome [9] 0 0
Overall Survival (OS)
Timepoint [9] 0 0
Up to approximately 3 years from randomization of last participant
Secondary outcome [10] 0 0
Number of participants who achieve CMR as assessed by Lugano criteria 2014
Timepoint [10] 0 0
Up to approximately 6 months from randomization

Eligibility
Key inclusion criteria
Inclusion Criteria

* Participant has histologically confirmed Grade 1, 2 or 3a follicular lymphoma (FL) or classic FL. Formalin-fixed paraffin embedded (FFPE) archival tissue from 1 year prior to screening is allowed. If more than 1 year has passed, then a fresh biopsy must be obtained to confirm the diagnosis.
* Have no prior systemic treatment for follicular lymphoma. Prior radiation therapy or surgery for previously diagnosed stage I disease is acceptable.
* Stage II to IV disease.
* Deemed to need treatment by treating investigator. Reasons for treatment can include, but are not limited to, the following:.

i) Bulky disease defined as:.

A. A nodal or extra nodal (except spleen) mass > 7cm in its greater diameter or, involvement of at least 3 nodal or extra nodal sites (each with a diameter greater than >3 cm).

ii) Presence of at least one of the following B symptoms:.

A. Fever (>38°C) of unclear etiology.

B. Night sweats.

C. Weight loss greater than 10% within the prior 6 months.

iii) Splenomegaly with inferior margin below the umbilical line.

iv) Any one of the following cytopenia due to lymphoma:.

A. Platelets <100,000 cells/mm3 (100 x 109/L).

B. Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L).

C. Hemoglobin < 10g/dL (6.25 mmol/L).

v) Pleural or peritoneal serous effusion (irrespective of cell content).

vi) Any compressive syndrome (for example, but not restricted to ureteral, orbital, gastrointestinal).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Clinical evidence of transformed lymphoma by investigator assessment.
* Follicular Large Cell as per WHO 5th classification or Grade 3b follicular lymphoma as per WHO 4th classification.
* Participant has any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participation in the study.
* 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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
3/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/11/2028
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Local Institution - 0046 - Liverpool
Recruitment hospital [2] 0 0
Local Institution - 0070 - Brisbane
Recruitment hospital [3] 0 0
Local Institution - 0181 - Traralgon
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
4101 - Brisbane
Recruitment postcode(s) [3] 0 0
3844 - Traralgon
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
Arizona
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
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
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
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
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
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Chile
State/province [23] 0 0
Región Metropolitana De Santiago
Country [24] 0 0
France
State/province [24] 0 0
Hauts-de-Seine
Country [25] 0 0
France
State/province [25] 0 0
Nord
Country [26] 0 0
France
State/province [26] 0 0
Vienne
Country [27] 0 0
France
State/province [27] 0 0
Paris
Country [28] 0 0
Germany
State/province [28] 0 0
Bayern
Country [29] 0 0
Germany
State/province [29] 0 0
Sachsen
Country [30] 0 0
Germany
State/province [30] 0 0
Dresden
Country [31] 0 0
Italy
State/province [31] 0 0
Lazio
Country [32] 0 0
Italy
State/province [32] 0 0
Milano
Country [33] 0 0
Italy
State/province [33] 0 0
Puglia
Country [34] 0 0
Italy
State/province [34] 0 0
Bari
Country [35] 0 0
Italy
State/province [35] 0 0
Bologna
Country [36] 0 0
Italy
State/province [36] 0 0
Napoli
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Jeonranamdo
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Pusan-Kwangyokshi
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Seoul-teukbyeolsi [Seoul]
Country [40] 0 0
Poland
State/province [40] 0 0
Kujawsko-pomorskie
Country [41] 0 0
Poland
State/province [41] 0 0
Mazowieckie
Country [42] 0 0
Poland
State/province [42] 0 0
Wielkopolskie
Country [43] 0 0
Spain
State/province [43] 0 0
Balears [Baleares]
Country [44] 0 0
Spain
State/province [44] 0 0
Valenciana, Comunitat
Country [45] 0 0
Spain
State/province [45] 0 0
Madrid
Country [46] 0 0
Taiwan
State/province [46] 0 0
Kaohsiung
Country [47] 0 0
Taiwan
State/province [47] 0 0
Taipei
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Hampshire
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Kent
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Midlothian
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Nottingham

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 Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See plan description
Available to whom?
See plan description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


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/NCT06425302