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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Celgene
Study ID
NCT04882163
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • Lymphoma, B-Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CC-220 — DRUG
    CC-220
  • Polatuzumab vedotin — DRUG
    Polatuzumab vedotin
  • Rituximab — DRUG
    Rituximab
  • Tafasitamab — DRUG
    Tafasitamab
  • Gemcitabine — DRUG
    Gemcitabine
  • Cisplatin — DRUG
    Cisplatin
  • Dexamethasone — DRUG
    Dexamethasone
  • Bendamustine — DRUG
    Bendamustine
  • Lenalidomide — DRUG
    Lenalidomide

Study Details

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.

Key Dates

Start date
Oct 10, 2021
Status verified
Sep 2021
Primary completion
Apr 8, 2026
Completion
Apr 7, 2029

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CC-220 + Polatuzumab vedotin + rituximab- Cohort A
    Subjects with Relapsed or refractory (R/R) Aggressive B-cell lymphoma (a-BCL) will receive CC-220 at a dose specified by cohort dose level in combination with polatuzumab vedotin plus rituximab.
  • Experimental: CC-220 + Tafasitamab- Cohort B
    Subjects with R/R a-BCL will receive CC-220 at a dose specified by cohort dose level in combination with tafasitamab.
  • Experimental: CC-220 + Rituximab + Chemo (Cohort C)
    Subjects with R/R a-BCL will receive CC-220 at a dose specified by cohort dose level in combination with rituximab plus chemotherapy (Gemcitabine, cisplatin, dexamethasone).
  • Experimental: CC-220 + Pola + Ritux vs Pola + Benda + Ritux (Cohort D)
    Subjects will be randomized to receive either CC-220 + Pola (polatuzumab vedotin) + Ritux (rituximab) or polatuzumab vedotin + bendamustine + rituximab in 21-day treatment cycles. CC-220 will be given at the RP2D declared in Part 1 of this study. Polatuzumab vedotin and rituximab will be administered at the same levels as in part 1. Bendamustine will be given to subjects randomized in the control arm at a dose of 90 mg/m2 IV on Days 1 and 2 of each of the first 6 cycles.
  • Experimental: CC-220 + tafasitamab vs Lenalidomide + Tafasitamab- Cohort E
    Subjects will be randomized to receive either CC-220 + tafasitamab or lenalidomide + tafasitamab in 28-day treatment cycles. CC-220 will be given at the RP2D declared in Part 1 of this study and the tafasitamab will be at the same levels as in Part 1. Lenalidomide will be administered to subjects randomized in the control arm at a dose of 25 mg/day orally, for 21 days out of 28, for up to 12 cycles.
  • Experimental: CC-220 + Rituximab + Chemo vs Rituximab + Chemo (Cohort F)
    Subjects will be randomized to receive either CC-220 + rituximab + chemotherapy (Gemcitabine, Cisplatin, Dexamethasone) or rituximab + chemotherapy (Gemcitabine, Cisplatin, Dexamethasone) in 21-day treatment cycles. CC-220 will be administered at the RP2D declared in Part 1 of this study and the combination medicines will be at the same levels as in part 1.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: During the First cycle (each cycle is 28 days) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Avera Cancer InstituteSioux FallsSouth Dakota57105-

Find similar trials in Boston, MA

By research site
Beth Israel Deaconess Medical Center· Boston, MAUniversity of Michigan Comprehensive Cancer Center· Ann Arbor, MIAvera Cancer Institute· Sioux Falls, SD

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