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Golcadomide, Poseltinib, and Rituximab for Relapsed/Refractory Diffuse Large B-cell Lymphoma

NCT07269639 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-08

No results posted yet for this study

Summary

This trial is a proof-of-concept, pilot study, phase I/II clinical trial aimed at generating preliminary data on the combination of golcadomide, poseltinib, and rituximab.

Conditions

  • Large B-Cell Lymphoma (LBCL)

Interventions

DRUG

Golcadomide + Poseltinib + Rituximab

Participants will receive 0.4 mg of golcadomide once daily for 14 consecutive days for 18 cycles in 28-day cycles. The first 6 cycles will be administered in combination with rituximab and poseltinib, while the remaining 12 cycles will be conducted with poseltinib alone. During the maintenance period (Cycles 7-18), the first day of study treatment administration with golcadomide is designated as Day 1 of each cycle. Rituximab can be administered with or up to 2 hours after the morning dose of golcadomide in the fed or fasted state. For Cycles 1-6, the first day of study treatment administration with rituximab is designated as Day 1 of each cycle. Rituximab will be administered as an IV infusion at a dose of 375 mg/m2 on Days 1, 8, 15, and 22 of Cycle 1, and Day 1 of Cycles 2-6. Poseltinib is administered orally twice daily, approximately every 12 hour. Part 1 (safety cohort) of the study will be conducted in up to approximately 9 participants to select the optimal RP2D of poseltinib.

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-12-01
Completion
2028-09-01

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07269639 on ClinicalTrials.gov