A Study to Compare the Efficacyand Safety of GolcadomidePlus R-CHOPvs Placebo Plus R- CHOPin Participantswith Previously Untreated High-riskLarge B-cellLymphoma

JRCT ID: jRCT2031240194

Registered date:28/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Large B-cell Lymphoma
• Date of first enrollment: 28/06/2024
• Target sample size: 66
• Countries of recruitment: Argentina,Japan,Australia,Japan,Austria,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,Chile,Japan,China,Japan,Colombia,Japan,Croatia,Japan,Czech Republic,Japan,Denmark,Japan,Finland,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,India,Japan,Malaysia,Japan,Mexico,Japan,New Zealand,Japan,Norway,Japan,Poland,Japan,Portugal,Japan,Romania,Japan,Saudi Arabia,Japan,Singapore,Japan,Slovakia,Japan,Spain,Japan,Republic of Korea, Sweden, Taiwan, Thailand, Turke,Japan
• Study type: Interventional

Intervention(s)

Golcadomide plus R-CHOP
Specified dose on specified days
Placebo plus R-CHOP
Specified dose on specified days

Outcome(s)

• Primary Outcome: Progression-Free Survival (PFS)
• Secondary Outcome: Overall Survival (OS), Event-Free Survival (EFS), Complete Metabolic Response (CMR), Minimal Residual Disease (MRD) negativity, Overall Response (OR), Duration of Response (DoR), Progression-Free Survival 2 (PFS2), Relative Dose Intensities (RDI), Quality Of Life (QOL), Safety

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1. Participant has histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated LBCL according to 2022 WHO classification including:
- DLBCL, NOS (including GCB and ABC types)
- High-grade B-cell lymphoma, with MYC and BCL2 rearrangements
- High-grade B-cell lymphoma, NOS
- T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL)
- EBV+ DLBCL
2. Participant has:
- IPI score 1 or 2 with LDH >= 1.3 x ULN and/or bulky disease defined as single lesion of >= 7 cm OR IPI >= 3
- Measurable disease defined by at least 1 FDG-avid lesion for FDG-avid subtype and 1 bi-dimensionally measurable (> 1.5 cm in longest diameter) disease by CT or MRI, as defined by the Lugano classification.
- Participants must have Ann Arbor Stage II-IV disease

Exclude criteria

1. Participant has any significant medical condition, active infection, laboratoryabnormality, or psychiatric illness that would prevent the participant from participating in the study.
2. Participant has any other subtype of lymphoma. Cases of PMBCL, primary cutaneous DLBCL-leg type, Grade 3b FL, FL transformed to LBCL, ALK-positive large B-cell lymphoma, PEL, Burkitt lymphoma are excluded.
3. Participant has documented or suspected CNS involvement by lymphoma.

Related Information

• Primary Sponsor: Hayakawa Jin
• Secondary ID(s): NCT06356129