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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06356129




Registration number
NCT06356129
Ethics application status
Date submitted
27/03/2024
Date registered
10/04/2024

Titles & IDs
Public title
Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma
Scientific title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Golcadomide Plus R-CHOP Chemotherapy vs Placebo Plus R-CHOP Chemotherapy in Participants With Previously Untreated High-risk Large B-cell Lymphoma (GOLSEEK-1)
Secondary ID [1] 0 0
2023-510178-15
Secondary ID [2] 0 0
CA073-1020
Universal Trial Number (UTN)
Trial acronym
GOLSEEK-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Large B-cell 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 - Placebo
Treatment: Drugs - Rituximab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Vincristine
Treatment: Drugs - Prednisone

Experimental: Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) -

Placebo comparator: Placebo + R-CHOP -


Treatment: Drugs: Golcadomide
Specified dose on specified days

Treatment: Drugs: Placebo
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS) assessed by the Investigator
Timepoint [1] 0 0
Up to approximately 67 months
Secondary outcome [1] 0 0
PFS assessed by the Investigator
Timepoint [1] 0 0
Up to approximately 67 months
Secondary outcome [2] 0 0
Overall survival (OS)
Timepoint [2] 0 0
Up to approximately 67 months
Secondary outcome [3] 0 0
Event-free survival (EFS)
Timepoint [3] 0 0
Up to approximately 67 months
Secondary outcome [4] 0 0
Complete Metabolic Response assessed by the Independent Response Adjudication Committee (IRAC)
Timepoint [4] 0 0
Up to approximately 18 weeks
Secondary outcome [5] 0 0
Minimal residual disease (MRD) negativity rate
Timepoint [5] 0 0
Up to approximately 18 weeks
Secondary outcome [6] 0 0
Progression-free survival (PFS) assessed by the IRAC
Timepoint [6] 0 0
Up to approximately 47 months
Secondary outcome [7] 0 0
Objective response (OR) assessed by the Investigator
Timepoint [7] 0 0
Up to approximately 18 weeks
Secondary outcome [8] 0 0
Complete metabolic response (CMR) assessed by the Investigator
Timepoint [8] 0 0
Up to approximately 18 weeks
Secondary outcome [9] 0 0
PFS24 assessed by the Investigator 24 months after randomization
Timepoint [9] 0 0
Up to 24 months
Secondary outcome [10] 0 0
Duration of response (DoR)
Timepoint [10] 0 0
Up to approximately 67 months
Secondary outcome [11] 0 0
Second progression-free survival (PFS2) assessed by the Investigator
Timepoint [11] 0 0
Up to approximately 67 months
Secondary outcome [12] 0 0
Relative dose intensity (%)
Timepoint [12] 0 0
Up to 18 weeks
Secondary outcome [13] 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 [13] 0 0
Up to approximately 67 months
Secondary outcome [14] 0 0
Time from randomization to meaningful improvement in primary domains of interest in the Functional Assessment of Cancer Treatment-Lymphoma (FACT-LymS) Questionnaire
Timepoint [14] 0 0
Up to approximately 67 months
Secondary outcome [15] 0 0
Mean change from baseline in the EORTC QLQ-C30
Timepoint [15] 0 0
Up to approximately 67 months
Secondary outcome [16] 0 0
Mean change from baseline in the FACT-LymS
Timepoint [16] 0 0
Up to approximately 67 months
Secondary outcome [17] 0 0
Number of participants with Adverse Events (AEs)
Timepoint [17] 0 0
Up to approximately 20 weeks
Secondary outcome [18] 0 0
Number of participants with treatment-emergent adverse events (TEAEs)
Timepoint [18] 0 0
Up to approximately 20 weeks
Secondary outcome [19] 0 0
Number of participants with laboratory abnormalities
Timepoint [19] 0 0
Up to approximately 20 weeks
Secondary outcome [20] 0 0
Number of participants with vital sign abnormalities
Timepoint [20] 0 0
Up to approximately 20 weeks

Eligibility
Key inclusion criteria
- Histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated large B-cell lymphoma (LBCL) according to 2022 world health organization (WHO) classification including:

i) Diffuse large B-cell lymphoma (DLBCL), not otherwise specified [including germinal center B-cell (GCB) and activated B-cell (ABC) types]

ii) High-grade B-cell lymphoma, with MYC and BCL2 rearrangements (HGBL-MYC/BCL2 double-hit lymphomas)

iii) High-grade B-cell lymphoma, not otherwise specified

iv) T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL)

v) Epstein-Barr virus + DLBCL

* International Prognostic Index (IPI) score 1 or 2 with lactate dehydrogenase (LDH) > 1.3 x upper limit of normal (ULN) and/or bulky disease defined as single lesion of = 7 cm OR IPI = 3.
* Measurable disease defined by at least 1 fluorodeoxyglucose (FDG)-avid lesion for FDG-avid subtype and 1 bi-dimensionally measurable (> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification.
* Must have Ann Arbor Stage II-IV disease.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
* Any other subtype of lymphoma. Cases of primary mediastinal (thymic) large B-cell lymphoma (PMBCL), primary cutaneous DLBCL-leg type, Grade 3b FL, indolent lymphoma transformed to large B-cell lymphoma (LBCL), Anaplastic lymphoma kinase (ALK) positive large B-cell lymphoma, primary effusion lymphoma, and Burkitt lymphoma.
* Documented or suspected central nervous system (CNS) involvement by lymphoma.
* 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
Actual
19/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/11/2029
Actual
Sample size
Target
850
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,VIC
Recruitment hospital [1] 0 0
Gosford Hospital - Gosford
Recruitment hospital [2] 0 0
Campbelltown Hospital - Sydney
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [5] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [6] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [7] 0 0
Peninsula Private Hospital - Frankston
Recruitment hospital [8] 0 0
Austin Health - Heidelberg
Recruitment hospital [9] 0 0
Western Health-Sunshine & Footscray Hospitals - St Albans
Recruitment hospital [10] 0 0
South West Healthcare - Warrnambool
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2560 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
0810 - Tiwi
Recruitment postcode(s) [5] 0 0
4575 - Birtinya
Recruitment postcode(s) [6] 0 0
4215 - Southport
Recruitment postcode(s) [7] 0 0
3195 - Frankston
Recruitment postcode(s) [8] 0 0
3084 - Heidelberg
Recruitment postcode(s) [9] 0 0
3021 - St Albans
Recruitment postcode(s) [10] 0 0
3280 - Warrnambool
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
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Illinois
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Córdoba
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Hessen
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Rheinland-Pfalz
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Sachsen-Anhalt
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Berlin
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Somogy
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Budapest
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Debrecen
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India
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Delhi
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Kerala
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Country [187] 0 0
Romania
State/province [187] 0 0
Mure?
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Romania
State/province [188] 0 0
Brasov
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Romania
State/province [189] 0 0
Cluj
Country [190] 0 0
Romania
State/province [190] 0 0
Ia?i
Country [191] 0 0
Romania
State/province [191] 0 0
Sibiu
Country [192] 0 0
Saudi Arabia
State/province [192] 0 0
Ash Sharqiyah
Country [193] 0 0
Saudi Arabia
State/province [193] 0 0
Riyadh
Country [194] 0 0
Singapore
State/province [194] 0 0
Central Singapore
Country [195] 0 0
Slovakia
State/province [195] 0 0
Banskobystrický Kraj
Country [196] 0 0
Slovakia
State/province [196] 0 0
Bratislava
Country [197] 0 0
Spain
State/province [197] 0 0
A Coruña [La Coruña]
Country [198] 0 0
Spain
State/province [198] 0 0
Barcelona [Barcelona]
Country [199] 0 0
Spain
State/province [199] 0 0
Bizkaia
Country [200] 0 0
Spain
State/province [200] 0 0
Canarias
Country [201] 0 0
Spain
State/province [201] 0 0
Gipuzkoa
Country [202] 0 0
Spain
State/province [202] 0 0
Madrid, Comunidad De
Country [203] 0 0
Spain
State/province [203] 0 0
Murcia, Región De
Country [204] 0 0
Spain
State/province [204] 0 0
Málaga
Country [205] 0 0
Spain
State/province [205] 0 0
Cáceres
Country [206] 0 0
Spain
State/province [206] 0 0
Madrid
Country [207] 0 0
Spain
State/province [207] 0 0
Salamanca
Country [208] 0 0
Spain
State/province [208] 0 0
Sevilla
Country [209] 0 0
Sweden
State/province [209] 0 0
Skåne Län [se-12]
Country [210] 0 0
Sweden
State/province [210] 0 0
Stockholms Län [se-01]
Country [211] 0 0
Sweden
State/province [211] 0 0
Uppsala Län [se-03]
Country [212] 0 0
Sweden
State/province [212] 0 0
Östergötlands Län [se-05]
Country [213] 0 0
Taiwan
State/province [213] 0 0
Chiayi
Country [214] 0 0
Taiwan
State/province [214] 0 0
Tainan
Country [215] 0 0
Taiwan
State/province [215] 0 0
Kaohsiung
Country [216] 0 0
Taiwan
State/province [216] 0 0
Taichung
Country [217] 0 0
Taiwan
State/province [217] 0 0
Taipei
Country [218] 0 0
Taiwan
State/province [218] 0 0
Taoyuan
Country [219] 0 0
Thailand
State/province [219] 0 0
Krung Thep Maha Nakhon
Country [220] 0 0
Thailand
State/province [220] 0 0
Chiang Mai
Country [221] 0 0
Turkey
State/province [221] 0 0
Ankara
Country [222] 0 0
Turkey
State/province [222] 0 0
Izmir
Country [223] 0 0
Turkey
State/province [223] 0 0
Mersin
Country [224] 0 0
Turkey
State/province [224] 0 0
Samsun
Country [225] 0 0
Turkey
State/province [225] 0 0
Trabzon

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
855-907-3286
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
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/disclosurecommitment.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/NCT06356129