Category
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Primary study
Registry of Trials»Clinical Trials Registry - India
Year
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2025
INTERVENTION: Intervention1: Golcadomide(BMS‐986369/CC‐99282) Plus R‐CHOP: 1) Drug: Golcadomide, Route of Administration: PO, Intervention Dose: 0.4mg once daily, Dosing Day(s)(21‐day cycle): 1‐7 2)Drug: Rituximab Route of Administration: IV/SC Intervention Dose:375 mg/m2 (IV) or 1400 mg (SC) Dosing Day(s)(21‐day cycle): 1 3) Drug: Cyclophosphamide Route of Administration: IV Intervention Dose:750 750 mg/m^2 Dosing Day(s)(21‐day cycle): 1 4) Drug: Doxorubicin Route of Administration: IV Intervention Dose:50 mg/m^2 Dosing Day(s)(21‐day cycle): 1 Vincristine Route of Administration: IV Intervention Dose:1.4 mg/m2 (ma Xof 2.0 mg total) Dosing Day(s)(21‐day cycle): 1 5) Drug: Prednisone/Prednisolone (Day 1 IV administration is acceptable) a Route of Administration: PO Intervention Dose:100 mg Dosing Day(s)(21‐day cycle): 1‐5 Abbreviations: IV, intravenous; PO, by mouth; R‐CHOP, rituximab, doxorubicin, vincristine, cyclophosphamide, and prednisone; SC, subcutaneous. a: Prednisolone IV products to be sourced locally by sites. Control Intervention1: Placebo Plus R‐CHOP: 1) Drug: Placebo Route of Administration: PO Intervention Dose: Once daily Dosing Day(s)(21‐day cycle): 1‐7 2)Drug: Rituximab Route of Administration: IV/SC Intervention Dose: 375 mg/m 2 (IV) or 1400 mg (SC) Dosing Day(s)(21‐day cycle): 1 3)Drug: Cyclophosphamide Route of Administration: IV Intervention Dose: 750 mg/m 2 Dosing Day(s)(21‐day cycle): 1 4)Drug: Doxorubicin Route of Administration: IV Intervention Dose: 50 mg/m 2 Dosing Day(s)(21‐day cycle): 1 5)Drug: Vincristine Route of Administration: IV Intervention Dose: 1.4 mg/m 2 (ma Xof 2.0 mg total) Dosing Day(s)(21‐day cycle): 1 6)Drug: Prednisone/Prednisolone (Day 1 IV administration is acceptable) a Route of Administration: PO Intervention Dose: 10 CONDITION: Health Condition 1: C858‐ Other specified types of non‐Hodgkin lymphoma PRIMARY OUTCOME: To evaluate the efficacy of golcadomide plus R‐CHOP vs placebo‐R‐CHOP in participants with untreated high‐risk large B‐cell lymphoma with respect to PFS as assessed by the investigator.Timepoint: At baseline, 24 Months and until Progression free survival up to 5 years or study achieves endpoints SECONDARY OUTCOME: evaluate the efficacy of golcadomide plus ; R‐CHOP vs placebo‐R‐CHOP in participants ; with untreated high‐risk large B‐cell lymphoma ; with respect to CMR as assessed by the IRACTimepoint: 1) Complete metabolic response per IRAC defined as participant achieving CMR at EOT as assessed by IRAC based on the Lugano response criteria ; 2) Baseline cycle 4 day 1 & cycle6 day 8, End of treatment visit. To evaluate the efficacy of golcadomide plus ; R‐CHOP vs placebo‐R‐CHOP in participants ; with untreated high‐risk large B‐cell lymphoma ; with respect to EFS as assessed by the ; InvestigatorTimepoint: 1) Death, disease progression or relapse, initiation of subsequent systemic anti‐lymphoma therapy,biopsy‐proven disease after end of treatment ; 2)Baseline cycle 4 day 1 & cycle6 day 8, End of treatment visit. To evaluate the efficacy of golcadomide plus ; R‐CHOP vs placebo‐R‐CHOP in participants ; with untreated high‐risk large B‐cell lymphoma ; with respect to MRD negativity at EOT.Timepoint: 1) MRD negativity defined as participant having undetectable ctDNA levels at EOT. ; 2) Baseline cycle 4 day 1 & cycle6 day 8, End of treatment visit. To evaluate the efficacy of golcadomide plus ; R‐CHOP vs placebo‐R‐CHOPTimepoint: 1) OS defined as the time from randomization to death ; from any cause ; 2) Baseline cycle 4 day 1 & cycle6 day 8, End of treatment visit. INCLUSION CRITERIA: A) · Participant has histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated LBCL according to 2022 WHO classification including: 1) DLBCL, NOS (including GCB and ABC types) 2) High‐grade B‐cell lymphoma, with MYC and BCL2 rearrangements 3) High‐grade B‐cell lymphoma, NOS 4) T‐cell/histiocyte/rich large B‐cell lymphoma (THRLBCL) 5) EBV plus DLBCL B) · Participant has: 1) IPI score 1 or 2 with LDH more than equal to 1.3 XULN and/or bulky disease defined as single lesion of more than equal to 7 cm OR IPI more than equal to 3 2) Measurable disease defined by at least 1 FDG‐avid lesion for FDG‐avid subtype and 1 bi‐ dimensionally measurable (more than 1.5 cm in longest diameter) disease by CT or MRI, as defined by the Lugano classification. 3) Participants must have Ann Arbor Stage II‐IV disease
Epistemonikos ID: c8fa54ebbf65792178b03c7950d8603959849370
First added on: Jul 14, 2025