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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06425302
Registration number
NCT06425302
Ethics application status
Date submitted
17/05/2024
Date registered
22/05/2024
Date last updated
31/05/2024
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
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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
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Secondary ID [1]
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U1111-1303-4594
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Secondary ID [2]
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CA073-1022
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Universal Trial Number (UTN)
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Trial acronym
GOLSEEK-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lymphoma, Follicular
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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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
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Treatment: Drugs: Vincristine
Specified dose on specified days
Treatment: Drugs: Prednisone
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Treatment: Drugs: Bendamustine
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants who achieve complete metabolic response (CMR) as assessed by Lugano criteria 2014
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Assessment method [1]
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Golcadomide + Rituximab arms only
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Timepoint [1]
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Up to approximately 12 months from participant randomization
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Secondary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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Up to 28 days after last dose
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Secondary outcome [2]
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Number of participants with Treatment-emergent AEs (TEAEs) as assessed by the NCI CTCAE criteria, v.5.0
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Assessment method [2]
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Timepoint [2]
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Up to 28 days after last dose
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Secondary outcome [3]
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Best Overall Response (OR)
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Assessment method [3]
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Defined as achieving CMR or partial metabolic response (PMR) based on Lugano criteria 2014
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Timepoint [3]
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Up to approximately 12 months from participant randomization
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Secondary outcome [4]
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Duration of Response (DoR)
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Assessment method [4]
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Defined as time from first confirmed response (Complete Response (CR) or Partial Response (PR)) to disease progression, start of new anti-lymphoma therapy, or death
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Timepoint [4]
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Up to approximately 3 years after randomization of the last participant
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Secondary outcome [5]
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Complete Response at 30 months (CR30)
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Assessment method [5]
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Defined as achieving CR based on Lugano criteria at 30 months from randomization
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Timepoint [5]
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At approximately 30 months from randomization
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Secondary outcome [6]
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Complete Metabolic Response at 6 months from the randomization (CMR6)
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Assessment method [6]
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Defined as achieving CMR based on Lugano criteria 2014 at 6 months from randomization
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Timepoint [6]
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At approximately 6 months from randomization
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Secondary outcome [7]
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Complete Metabolic Response at 12 months from the randomization (CMR12)
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Assessment method [7]
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Defined as achieving CMR based on Lugano criteria 2014 at 12 months from randomization
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Timepoint [7]
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At approximately 12 months from randomization
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Secondary outcome [8]
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Progression Free Survival (PFS)
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Assessment method [8]
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Defined as time from date of randomization to first occurrence of disease progression or death from any cause
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Timepoint [8]
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Up to approximately 3 years from randomization of last participant
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Secondary outcome [9]
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Overall Survival (OS)
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Assessment method [9]
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Defined as time from date of randomization to death from any cause
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Timepoint [9]
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Up to approximately 3 years from randomization of last participant
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Secondary outcome [10]
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Number of participants who achieve CMR as assessed by Lugano criteria 2014
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Assessment method [10]
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Rituximab + Chemotherapy arm only
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Timepoint [10]
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Up to approximately 6 months from randomization
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Eligibility
Key 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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
3/08/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
27/11/2028
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Actual
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Sample size
Target
90
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Local Institution - 0046 - Liverpool
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Recruitment hospital [2]
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Local Institution - 0070 - Brisbane
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Recruitment hospital [3]
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Local Institution - 0181 - Traralgon
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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4101 - Brisbane
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Recruitment postcode(s) [3]
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3844 - Traralgon
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Recruitment outside Australia
Country [1]
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United States of America
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Alabama
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United States of America
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State/province [2]
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Alaska
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United States of America
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Arizona
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United States of America
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California
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Country [5]
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United States of America
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District of Columbia
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United States of America
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Florida
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Country [7]
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United States of America
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Illinois
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Kansas
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United States of America
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Louisiana
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United States of America
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Maryland
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Massachusetts
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New Jersey
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New York
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Utah
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Washington
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Brazil
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Rio Grande Do Sul
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Brazil
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São Paulo
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Brazil
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Rio de Janeiro
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Ontario
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Chile
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Región Metropolitana De Santiago
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Hauts-de-Seine
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France
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Nord
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Vienne
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France
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Paris
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Bayern
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Germany
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Germany
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Lazio
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Kujawsko-pomorskie
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Valenciana, Comunitat
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Spain
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Madrid
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Kaohsiung
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Taipei
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Hampshire
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Kent
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United Kingdom
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Midlothian
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United Kingdom
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Nottingham
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Celgene
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the efficacy and safety of golcadomide in combination
with rituximab in participants with newly diagnosed advanced stage Follicular Lymphoma (FL).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06425302
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Phone
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Fax
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Email
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Contact person for public queries
Name
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BMS Study Connect Contact Center www.BMSStudyConnect.com
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Address
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Country
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Phone
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855-907-3286
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06425302
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