CTRI/2026/02/103009 [Registered on: 04/02/2026] Trial Registered Prospectively
Last Modified On:
03/02/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
A multicenter, randomized, open label Phase 3 study to compare the efficacy and safety of golcadomide in combination with rituximab vs investigators choice in participants with relapsed/refractory follicular lymphoma who have received at least one line of prior systemic therapy
Scientific Title of Study
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 withRelapsed/Refractory Follicular Lymphoma
(GOLSEEK-4)
Trial Acronym
(GOLSEEK-4)
Secondary IDs if Any
Secondary ID
Identifier
2024-519152-82
EudraCT
IND 140646
Other
U1111-1314-3909
UTN
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Shilpi Sinha
Designation
Director, RCO Head
Affiliation
Bristol-Myers Squibb India Pvt. Ltd.
Address
One International Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphistone (W), Mumbai One International Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphistone (W), Mumbai Mumbai MAHARASHTRA 400013 India
Phone
09833515863
Fax
Email
shilpi.sinha@bms.com
Details of Contact Person Scientific Query
Name
Dr Kartik Doshi
Designation
Associate Director, Medical Lead
Affiliation
Bristol-Myers Squibb India Pvt. Ltd.
Address
Bristol-Myers Squibb India Private Limited, One International Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphinstone (W), Mumbai- 400013 India
One International Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphistone (W), Mumbai Mumbai MAHARASHTRA 400013 India
Phone
912266288600
Fax
Email
kartik.doshi@bms.com
Details of Contact Person Public Query
Name
Shilpi Sinha
Designation
Director, RCO Head
Affiliation
Bristol-Myers Squibb India Pvt. Ltd.
Address
One International Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphistone (W), Mumbai One International Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphistone (W), Mumbai Mumbai MAHARASHTRA 400013 India
Phone
09833515863
Fax
Email
shilpi.sinha@bms.com
Source of Monetary or Material Support
BRISTOL MYERS SQUIBB INDIA PRIVATE LIMITED One International Center, 6th Floor, Tower 1, Senapati Bapat Marg, Elphinstone (W), Mumbai- 400013 India
Primary Sponsor
Name
Celgene Corporation
Address
Bristol Myers Squibb Company, Route 206 & Province Line Road, Princeton, NJ 08543
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
Australia Brazil Canada Chile China Finland France Germany Greece India Italy Japan Netherlands Poland Saudi Arabia Spain Turkey United Arab Emirates United Kingdom United States of America Democratic People's Republic of Korea
Sites of Study
No of Sites = 5
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Deepam Pushpam
All India Institute of Medical Sciences(AIIMS)
Ansari Nagar East, New Delhi-110029 New Delhi DELHI
09650629370
deepampushpam@gmail.com
Dr SVSS Prasad
Apollo Cancer Hospital Apollo Hospital
Jubilee Hills, Hyderabad,
Telangana 500096
Hyderabad TELANGANA
919848018804
svss.prasad@yahoo.co.in
Dr Sharat Damodar
Mazumdar Shaw Medical Center, Narayana Hrudayalaya Ltd
7h Floor - A Block, Room No - F-6
258/A, Bommasandra Industrial Area,
Hosur Road, Bangalore - 560099
Karnataka, India
Bangalore KARNATAKA
919880437134
sharat.damodar.dr@narayanahealth.org
Dr Vashista Maniar
MOC Cancer Care & Research Centre
1st Floor, Shreepati Arcade, Nana Chowk, Kemps
Corner, August Kranti Road, Grant Road West,
Mumbai 400036, Maharashtra, India
Mumbai MAHARASHTRA
919819834571
vpm@mocindia.co.in
Dr Ganesh Shivlingrao Jaishetwar
Yashoda Super Speciality Hospitals
Survey No. 41/14, Jntu To Hitech City Road, Hyderabad,
Telangana, 500084, India
Hyderabad TELANGANA
919849388806
ganeshjaishetwar@gmail.com
Details of Ethics Committee
No of Ethics Committees= 5
Name of Committee
Approval Status
Institute Ethics Committee
Submittted/Under Review
Institutional Ethics Committee – Clinical Studies, Apollo Hospitals Enterprise Limited
Approved
Institutional Ethics Committee, Yashoda Academy of Medical Education and Research
Submittted/Under Review
Mumbai Oncocare Centre IEC Cellcure-Cancer Centre Private Limited
Golcadomide: 0.4 mg orally once daily, Days 1–14 of each 28-day cycle, for up to 12 cycles.
Rituximab:
Cycle 1: 375 mg/m² IV at Day 1, then either 375 mg/m² IV or 1400 mg subcutaneous on Days 8, 15, and 22.
Cycles 2–5: Day 1 of each cycle (either IV 375 mg/m² or SC 1400 mg).
Split dosing over 2 days may be considered per local practice.
Comparator Agent
Lenalidomide + Rituximab
Lenalidomide: 20 mg orally once daily, Days 1–21 of each 28-day cycle, for up to 12 cycles.
Dose reductions allowed for toxicity: 15 mg, 10 mg, 5 mg.
For moderate renal impairment (CrCL 30–60 mL/min): start at 10 mg once daily.
Rituximab:
Cycle 1: 375 mg/m² IV at Day 1, then either 375 mg/m² IV or 1400 mg SC on Days 8, 15, and 22.
Cycles 2–5: Day 1 of each cycle.
Comparator Agent
Rituximab + Bendamustine
Rituximab: 375 mg/m² IV at Day 1 of each cycle (or SC 1400 mg from Cycle 2).
Bendamustine: 90 mg/m² IV, Days 1–2.
Rituximab: 375 mg/m² IV at Day 1 of each cycle (or SC 1400 mg from Cycle 2).
Cyclophosphamide: 750 mg/m² IV, Day 1.
Doxorubicin: 50 mg/m² IV, Day 1.
Vincristine: 1.4 mg/m² IV (max 2.0 mg total), Day 1.
Prednisone/Prednisolone: 100 mg PO/IV, Days 1–5.
IV allowed per institutional practice.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
Signed Written Informed Consent
1) Participants must have signed and dated an IRB or IEC approved written ICF in accordance with regulatory, local, and institutional guidelines. This ICF must be obtained before performing any protocol-related procedures that are not part of normal patient care.
Type of Participant and Target Disease Characteristics
2) Participant has histologically confirmed FL (Grade 1, 2, or 3a) as assessed by local pathology. Adequate fresh tumor biopsy tissue or archived tumor biopsy (preferably 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.
a) Participant must meet criteria based on investigator assessment to receive systemic therapy.
b) Participant must have relapsed or refractory disease, as assessed by the investigator and defined below
i) Relapsed FL is defined as relapse after an initial response of CR or PR to the most recent prior therapy.
ii) Refractory FL is defined as best response of SD or progressive disease to the most recent prior therapy.
3) Participant has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of lesser than or equal to 2, ECOG PS 3 is allowed if it is lymphoma-related and not due to comorbidities.
4) 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 the Lugano Classification.
5) 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.
6) Participants with an indication for anti-lymphoma treatment as per investigator assessment based on one of the following criteria(modified GELF criteria), but not limited to:
a) Bulky disease defined as a nodal or extra nodal (except spleen) mass greater than 7 cm in its greater diameter or, involvement of at least 3 nodal or extra nodal sites (each with a diameter greater than greater than 3 cm)
b) Presence of at least one of the following B symptoms
i) Fever (greater than 38°C) of unclear etiology
ii) Night sweats
iii) Weight loss greater than 10 percent within the prior months c) Splenomegaly with inferior margin below the umbilical line d) Any one of the following cytopenia due to lymphoma:
i) Platelets less than 100,000 cells per mm3 (100 into 109perL)
ii) Absolute neutrophil count (ANC) less than 1,000 cells per mm3 (1.0 into 109per L)
iii) Hemoglobin less than 10gperdL (6.25 mmolperL)
e) Pleural or peritoneal serous effusion (irrespective of cell content)
f) Any compressive syndrome (for example but not restricted to ureteral, orbital, gastrointestinal)
7) Participant must have the following laboratory values:
a) Absolute neutrophil count greater than or equal to 1,000 cells/mm3 (1.0 into 109 perL) or greater than or equal 0.5 into 109 perL in case of documented bone marrow involvement by lymphoma or hypersplenism secondary from spleen involvement by lymphoma, without growth factor support for 7 days (14 days if pegylated growth factor is used).
b) Platelet count greater than or equal 75,000 cells permm3 (75 into 109 perL) unless greater than or equal 50,000 cells per mm3 (50 into 109 perL) secondary to documented bone marrow involvement by lymphoma or hypersplenism secondary from spleen involvement by lymphoma, without transfusions for 7 days.
c) Hemoglobin greater than or equal 7.5 g perdL.
8) Estimated Glomerular function (eGFR) of 7) Participant must have the following laboratory values:
a) Absolute neutrophil count greater than or equal to 1,000 cells per mm3 (1.0 into 109 perL) or greater than or equal 0.5 into 109per L in case of documented bone marrow involvement by lymphoma or hypersplenism secondary from spleen involvement by lymphoma, without growth factor support for 7 days (14 days if pegylated growth factor is used).
b) Platelet count greater than or equal 75,000 cells per mm3 (75 into 109 perL) unless greater than or equal 50,000 cellspermm3 (50 into 109 perL) secondary to documented bone marrow involvement by lymphoma or hypersplenism secondary from spleen involvement by lymphoma, without transfusions for 7 days.
c) Hemoglobin greater than or equal 7.5 gperdL.
30 mLper min per1.73m2 using the modification of diet in renal disease (MDRD) formula (refer to APPENDIX 13) or Chronic Kidney Disease - Epidemiology Collaboration formula (CKD-EPI). The same eGFR cutoff applies in case of documented renal involvement by lymphoma.
d) Serum aspartate transaminase (AST or SGOT) or alanine transaminase (ALT or SGPT) less than or equal to 2.5 into upper limit of normal (ULN). In case of documented liver involvement by lymphoma, ALT or SGPT and AST or SGOT must be less than or equal 5.0 into ULN.
e) Serum total bilirubin less than or equal 1.5 into 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 less than or equal to 3.0 into ULN (corresponding to moderate dysfunction as per NCI ODWG criteria). For cases of Gilberts syndrome, serum total bilirubin less than or equal 5.0 into ULN.
9) Adequate cardiac function for participants receiving anthracycline based chemotherapy, defined as left ventricular ejection fraction (LVEF) greater than or equal to 40 percent as assessed by echocardiogram (ECHO) as standard of care or multi-gated acquisition scan (MUGA) if ECHO is not conclusive.
10) Participant is willing to receive thromboembolic medications if deemed high risk for thromboembolic events.
11) Participant is able to understand and voluntarily sign an ICF prior to any study-related assessments or procedures being conducted.
12) Participant is willing and able to adhere to the study visit schedule and all other protocol requirements.
13) Participant agrees to refrain from donating blood while on study intervention, during dose interruptions, and for at least 28 days following the last dose of study intervention.
Age of Participant
14) Participant must beat least 18 years of age, inclusive, at the time of signing the ICF.
Reproductive Status
Note: The investigator or designee shall counsel IOCBP participants (as defined in APPENDIX 3 and APPENDIX 4) and male (as assigned at birth) participants who are sexually active with IOCBP on the importance of pregnancy prevention, the implications of an unexpected pregnancy, and the potential of fetal toxicity occurring due to transmission of study intervention present in seminal fluid to a developing fetus, even if the participant has undergone a successful vasectomy or if the partner is pregnant.
Note: The investigator or designee shall evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
Note: Local laws and regulations may require the use of alternative and/or additional contraceptive methods.
Note: The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to potentially decrease the risk for inclusion of an individual with an undetected pregnancy.
15) Female (as assigned at birth) participants must adhere to Pregnancy Prevention Plan requirements (See APPENDIX 3 and APPENDIX 4), including:
a) Female (as assigned at birth) participants who are not of childbearing potential (as defined in APPENDIX 3 and APPENDIX 4) must have documented proof. Documentation can be obtained from the site personnel’s review of the participant’s medical records, medical examination, or medical history interview.
b) Individuals who are not of childbearing potential are exempt (See APPENDIX 3 and APPENDIX 4) from contraceptive requirements.
c) IOCBP must have 2 negative pregnancy tests (minimum sensitivity 25 mIU per mL or equivalent units of human chorionic gonadotropin) as verified by the investigator prior to starting golcadomide
i) A negative serum pregnancy test (sensitivity of at least 25 mIU per mL) at screening (between 10 to 14 days prior to C1D1).
ii) A negative serum or urine pregnancy test (Investigators discretion) within 24 hours prior to Cycle 1 Day 1 of study treatment. Note the screening serum pregnancy test can be used as the test prior to Day 1 study treatment if it is performed within the prior 24 hours.
d) Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with two forms of contraception one highly effective, and one additional effective (barrier) measure of contraception without interruption 28 days prior to starting IP, during the study treatment (including dose interruptions), and for at least 28 days after the last dose of golcadomide and according to the approved product/prescribing information for components of chemotherapy regimens, rituximab and lenalidomide, as applicable, whichever is longer. Agree to be counseled about pregnancy precautions and risk of fetal exposure.
16) IOCBP (assigned females at birth) must agree to abstain from breastfeeding during study participation and for at least 28 days after golcadomide discontinuation and according to the approved product or prescribing information for components of chemotherapy regimens, rituximab and lenalidomide.
a) Agree to ongoing pregnancy testing during the course of the study, and after the end of study intervention. This applies even if the participant practices true abstinence from heterosexual contact.
b) IOCBP and male (as assigned at birth) participants who are sexually active with IOCBP must agree to follow instructions for method(s) of contraception as described in Pregnancy Prevention Plan for golcadomide and included in the ICF.
i) Avoid conceiving for up to 28 days after the last dose of golcadomide.
ii) Agree to refrain from donating ova while on golcadomide for at least 28 days after its discontinuation.
c) Male (as assigned at birth) participants must adhere to Pregnancy Prevention Plan requirements (See APPENDIX 3 and APPENDIX 4)
i) Practice true abstinence (which must be reviewed monthly, and source documented) or agree to use a condom during sexual contact with a pregnant female or an FCBP while participating in the study, during dose interruptions and for at least 28 days for golcadomide, and according to the approved product/prescribing information for components of chemotherapy regimens, rituximab and lenalidomide, as applicable, whichever is longer, even if he has undergone a successful vasectomy.
ii) Must agree to refrain from donating sperm while on study intervention, during dose interruptions, and for at least 28 days after the last dose of golcadomide or according to the approved product/prescribing information for components of chemotherapy regimens, rituximab and lenalidomide, as applicable, whichever is longer.
iii) Agree to be counseled about pregnancy precautions and risk of fetal exposure.
iv) IOCBP partners of male participants should be advised to use a highly effective method of contraception during the intervention period and for at least 28 days after the last dose of golcadomide or according to the approved product/prescribing information for components of chemotherapy regimens, rituximab and lenalidomide, as applicable, for the male participant.
v) Male participants with a pregnant or breastfeeding partner must agree to remain abstinent from sexual activity or use a male condom during any sexual activity (eg, vaginal, anal, oral), even if the participant has undergone a successful vasectomy, during the intervention period and for at least 28 days after the last dose of golcadomide or according to the approved product/prescribing information for components of chemotherapy regimens, rituximab and lenalidomide, as applicable.
vi) Breastfeeding partners of male participants should be advised to consult their health care provider about using appropriate highly effective contraception during the time the male participant is required to use condoms.
ExclusionCriteria
Details
Medical Conditions
1) Evidence or history of composite DLBCL and FL or of transformed NHL or any other indolent lymphoma.
2) Follicular large cell as per 5th World Health Organization (WHO) sub-classification (grade 3b FL per WHO 4th classification) or duodenal type FL.
3) 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.
4) Participant has any condition that confounds the ability to interpret data from the study based on Investigator’s or Sponsor’s judgment.
5) Presence or history of central nervous system (CNS) involvement by lymphoma. 6) History of stroke or intracranial hemorrhage within 6 months prior to enrollment. 7) Deep venous thrombosis or Pulmonary embolism within 1 month prior to enrollment. 8) Participants with a history of progressive multifocal leukoencephalopathy. 9) Participant has any other subtype of lymphoma.
10) Participant has persistent diarrhea or malabsorption greater than or equal to Grade 2 (NCI CTCAE v5.0), despite medical management.
11) History of another primary malignancy that has not been in remission for greater than or equal to 3 years except for the following non-invasive malignancies:
a) Basal cell carcinoma of the skin.
b) Squamous cell carcinoma of the skin.
c) Carcinoma in situ of the cervix.
d) Carcinoma in situ of the breast.
e) Incidental histologic finding of prostate cancer (T1a or T1b using the TNM tumor nodes, metastasis clinical staging system) or prostate cancer that is curative.
f) Other completely resected Stage 1 solid tumor that have been treated with curative and have a low risk for recurrence as per the treating investigator. Reproductive Status
12) Individuals who are breastfeeding
13) Individuals who are pregnant
Prior/Concomitant Therapy
14) Inability to comply with restrictions and prohibited treatments as listed in Section 7.7 Concomitant Therapy.
15) Participants who are refractory to both chemotherapies as well as lenalidomide, defined as:
• SD or 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
• SD or progressive disease as best response to lenalidomide based regimen or a response to lenalidomide based regimen that lasted less than 6 months
Note Participants previously refractory to lenalidomide andor exposed will not be randomized in the R-Lenalidomide arm participants who are refractory to R-Chemotherapy (both CHOP and Bendamustine) will not be randomized to R-Chemotherapy arm.
16) Participant is on chronic systemic immunosuppressive therapy or corticosteroids (prednisone or equivalent not exceeding 10 mg per day within the last 4 weeks is allowed) stable use of inhaled or topical corticosteroids is allowed.
17) Participant has current treatment with strong cytochrome P450 3A4or5 (CYP3A4or5) inhibitors or inducers (see corresponding Section 7.7.1). The washout period for strong CYP3A4or5 inhibitors or inducers is 7 days or 5 half-lives (whichever is longer) before initiation of golcadomide. Co-adminsitration of moderate cytochrome P450 3A4or5 (CYP3A4or5) inhibitors or inducers may be permitted after discussion with Medical Monitor.
18) Participant received live attenuated vaccines within 3 months prior to initiation of study intervention or live coronavirus disease 2019 (COVID-19) vaccines within 30 days prior to C1D1.
Physical and Laboratory Test Findings
19) Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population or that places the participant at unacceptable risk if he or she were to participate in the study.
20) Participant has known seropositivity for or active viral infection with human immunodeficiency virus (HIV).
21) Participant has known chronic active hepatitis B (hepatitis B virus surface antigen HBsAg positive andor hepatitis B core antibody anti-HBc positive with viral DNA positive) or chronic active hepatitis C (positive serology requiring treatment and/or with evidence of liver damage) infection. Participants with hepatitis C who have completed treatment and eradicated infection (HCV positive serology with negative PCR) may be eligible.
22) Participant had major surgery less than or equal to 4 weeks (except lymph node biopsy) prior to initiation of treatment.
23) Participant has any condition causing inability to swallow tablets or capsules. Allergies and Adverse Drug Reactions
24) History of allergy or hypersensitivity to any component (including excipients) of the study intervention or related compounds.
25) Any prior allergy to CHOP or bendamustine.
26) Known sensitivity or allergy to murine products.
27) Participant has known allergy to thalidomide, pomalidomide, or lenalidomide. Prior history of rash due to these drugs, that resolved with medical management, is not an exclusion criterion.
Other Exclusion Criteria
28) Prisoners or participants who are involuntarily incarcerated. (Note Under certain specific circumstances and only in countries where local regulations permit, a person who has been imprisoned while on study may be permitted to continue as a participant. Strict conditions apply).
29) Participation in another therapeutic clinical trial concurrent with this study.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Progression-free survival (PFS) per IRAC is
defined as the time from randomization to
the first disease progression based on Lugano
2014classification guidelines as assessed by
IRAC or death from any cause, whichever
occurs earlier
Up to approximately 32 Months
Secondary Outcome
Outcome
TimePoints
Overall Response (OR) per IRAC is achieved if a
participantachieves an objective partial response (PR) or
better during the study based on Lugano 2014
classification guidelines as assessed by IRAC
OR per IRAC will be analyzed using the Miettinen
and Nurminen (M&N) method with stratification
factors as factorsamong all randomized
participants. Missing data will be imputed with the
worst possible values (non-responder). The estimate
of difference in OR proportions together with its
95% confidence interval will be reported
Overall Survival (OS) is defined as the time from
randomization to time of death due to any cause
Same method as that used for the primary endpoint
PFS per IRAC
Progression-free survival (PFS) per investigator is defined
as the time from randomization to the first disease
progression based on Lugano 2014 classification
guidelines asassessed by theinvestigatoror death from
any cause, whichever occurs earlier
The PFS function for each treatment group will be
estimated using the KM method
Overall Response (OR) per investigator is achieved if a
participantachieves an objective partial response (PR) or
better during the study based on Lugano 2014
classification guidelines as assessed bytheinvestigator
The estimate of difference in proportions together
with its two-sided 95% confidence interval will be
reported.
Complete Metabolic Response (CMR) per investigatoris
achieved if a participantachieves a complete metabolic
response during the study based on Lugano 2014
classification guideline as assessed by the investigator
The estimate of difference in proportions together
with its two-sided 95% confidence interval will be
reported.
Duration of Response (DoR) is defined as the time from
first response (CR or PR) to the first disease progression
based on Lugano 2014 classification guidelines, start of
new anti-lymphoma therapy or death from any cause,
whichever occurs earlier
The DoR function for each treatment group will be
estimated using the KM method
Time to Next Anti-lymphoma Treatment (TTNT) is
defined as the time from randomization to initiation of
new anti-lymphoma treatment or death from any cause,
whichever occurs earlier
The TTNT function for each treatment group will
be estimated using the KM method.
Event-free Survival (EFS)is defined as the time from
randomization to death from any cause, first disease
progression based on Lugano 2014classification
guidelines, or start of new anti-lymphoma therapy, or
transformation to aggressive lymphoma whichever occurs
earlier
The EFS function for each treatmentgroup will be
estimated using the KM method.
PFS2 is defined as the time from randomization to disease
progression after NALT as assessed by the investigator or
death due to any cause, whichever occurs earlier
The PFS2 function for each treatment group will be
estimated using the KM method
Change from baseline in domains of the EORTC QLQ-C30 and the EORTC QLQ-NHL-LG20
bserved and mean changes from baseline over
time on the EORTC QLQ-C30 and EORTC QLQ-NHL-LG20 for COA-evaluable population.Descriptive summary statistics will be used as
appropriate.
MRD negativityisachieved if aparticipant has
undetectable ctDNA levels at EOT
Same method as that used for the key secondary
endpoint OR per IRAC will be performed on MRD-evaluable population. This endpoint will be tested
without adjusting for multiplicity and its p-value
will be provided for illustrative purpose.
Target Sample Size
Total Sample Size="400" Sample Size from India="16" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
01/05/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
01/07/2025
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="7" Months="0" Days="0"
Recruitment Status of Trial (Global)
Open to Recruitment
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Follicular lymphoma (FL) is the most common subtype of indolent non-Hodgkin lymphoma
(NHL) in the United States (US) and Western Europe, accounting for approximately 70% of
indolent NHL, and is the second most common type of NHL, accounting for about 20% of all
NHL cases. The incidence of FL in the US was 2.6cases per 100,000 persons per year based on
2015-2019 cases, age-adjusted, with a death rate of 0.4 casesper 100,000 persons per year.
For patients with relapsed/refractory (R/R)FL after at least 1 prior line of therapy, the most
common approach includes immunotherapy, targeted therapiescombinations such as
lenalidomide with rituximab (R-Lenalidomide) and non-crossed resistant chemoimmunotherapy.
Despite the high initial response rates, these therapies are not curative in the long term, leading
to eventual relapse and requiring subsequenttreatment for disease control.
Recently,T-cell directed therapies such as CAR T-cells and bispecific antibodies, have gained
accelerated/conditional regulatory approval in 3L+ FL based on single arm studies showing
improvement in objective or complete response rates above what would be expected from
historical controls. Despite this, the impact of these therapies on patient’s survival remains
unclear. Additionally, tolerability concerns and logistical challenges associated with these
therapies result in many patients not being able to receive them.
Consequently, there remains an unmet need for the development of highly efficacious and well-tolerated regimens that improve outcomes in patients with R/R FL who have received 1or more