NCT04882163

Study to Evaluate Tolerability of Iberdomide (CC-220) in Combination With Polatuzumab Vedotin Plus Rituximab or Tafasitamab or Rituximab Plus Chemotherapy in B-cell Lymphoma

A Phase 1B/2 Randomized, Multicenter, Open-Label Study Of Iberdomide (CC-220) In Combination With Polatuzumab Vedotin Plus Rituximab Or Tafasitamab Or Rituximab Plus Chemotherapy For Subjects With Relapsed Or Refractory Aggressive B-Cell Lymphoma

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1b/2 randomized study of Iberdomide (CC-220) added to 3 different combination regimens (polatuzumab vedotin plus rituximab (Cohort A), tafasitamab (Cohort B), rituximab plus gemcitabine and platinum-based chemotherapy (Cohort C)) for participants with relapsed or refractory aggressive B-cell lymphoma (R/R a-BCL). All 3 cohorts will be open for enrollment at study start. Part 1 (dose escalation) will be followed by Part 2 (dose expansion), in which participants will be randomized to one of three cohorts, with CC-220 at the recommended Phase 2 Dose in combination with the Cohorts A, B and C treatment that is compared to their individual standard of care regimen.

Conditions

• Lymphoma, B-Cell

Interventions

Type	Name	Description
DRUG	CC-220	CC-220
DRUG	Polatuzumab vedotin	Polatuzumab vedotin
DRUG	Rituximab	Rituximab
DRUG	Tafasitamab	Tafasitamab
DRUG	Gemcitabine	Gemcitabine
DRUG	Cisplatin	Cisplatin
DRUG	Dexamethasone	Dexamethasone
DRUG	Bendamustine	Bendamustine
DRUG	Lenalidomide	Lenalidomide

Timeline

• Start date: 2021-10-10
• Primary completion: 2026-04-08
• Completion: 2029-04-07
• First posted: 2021-05-11
• Last updated: 2021-10-05

Locations

27 sites across 8 countries: United States, Austria, Belgium, France, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study