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
NCT04882163 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL
Last updated 2021-10-05
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
- DRUG
-
CC-220
CC-220
- DRUG
-
Polatuzumab vedotin
Polatuzumab vedotin
- DRUG
-
Rituximab
- DRUG
-
Tafasitamab
Tafasitamab
- DRUG
-
Gemcitabine
- DRUG
-
Cisplatin
- DRUG
-
Dexamethasone
- DRUG
-
Bendamustine
- DRUG
-
Lenalidomide
Sponsors & Collaborators
-
Celgene
lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-10
- Primary Completion
- 2026-04-08
- Completion
- 2029-04-07
- FDA Drug
- Yes
Countries
- United States
- Austria
- Belgium
- France
- South Korea
- Spain
- Taiwan
- United Kingdom
Study Locations
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