OncRef

Clinical Trial: NCT04884035

Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:Celgene
Information Provided By:Celgene
Last Update Posted:2026-07-20

Study Overview

Brief Summary

This is a Phase 1b study consisting of 2 parts: a dose escalation (Part 1) of CC-220 or CC-99282 added to the standard R-CHOP-21 regimen for first-line treatment of a-BCL. The dose escalation (Part 1) will consist of 2 parallel arms in combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP-21); CC-220 and R-CHOP-21 or CC-99282 and R-CHOP-21. Part 1 will be followed by a randomized dose expansion (Part 2) with CC-220 and/or CC-99282 at the Recommended Phase 2 Dose (RP2D) in combination with R-CHOP-21. A polatuzumab-R-CHP regimen in combination with CC-220 or CC-99282 will be explored with the addition of a new cohort only after the RP2D for the CC-220 and/or CC-99282 and R-CHOP-21 combination has been defined.

Official Title

A Phase 1b, Open Label, Global, Multicenter, Dose Determination, Randomized Dose Expansion Study to Determine the Maximum Tolerated Dose, Assess the Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of Iberdomide (CC-220) in Combination With R-CHOP-21 and CC-99282 in Combination With R-CHOP-21 for Subjects With Previously Untreated Aggressive B-cell Lymphoma

Conditions

Lymphoma, B-Cell

Intervention / Treatment

  • Drug: CC-220
  • Drug: Rituximab
  • Drug: Cyclophosphamide
  • Drug: Doxorubicin
  • Drug: Vincristine
  • Drug: Prednisone
  • Drug: CC-99282
  • Drug: Polatuzumab vedotin
  • Drug: Rituximab

Other Study ID Numbers

  • CC-220-DLBCL-001
  • 2023-506094-35
  • 2023

Start Date (Actual)

2021-09-15

Primary Completion Date (Estimated)

2028-12-01

Study Completion Date (Estimated)

2028-12-01

Enrollment (Estimated)

224

Study Type

Interventional

Phase

Phase 1