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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Celgene
Study ID
NCT04884035
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Lymphoma, B-Cell

Eligibility Criteria

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

Interventions

  • CC-220 — DRUG
    CC-220 by mouth at the assigned dose starting on Day 1 for 14 consecutive days of the 21-day treatment cycle for 6 cycles of treatment.
  • Rituximab — DRUG
    Rituximab 375 mg/m2 on Day 1 by intravenous (IV) infusion or 1400 mg (SC) subcutaneous (from Cycle 2) of a 21-day treatment cycle for up to a total of 6 cycles
  • Cyclophosphamide — DRUG
    Cyclophosphamide 750mg/m2 on Day 1 by IV infusion of a 21-day treatment cycle for up to a total of 6 cycles
  • Doxorubicin — DRUG
    Doxorubicin 50 mg/m2 IV infusion on Day 1 of a 21-day treatment cycle for up to a total of 6 cycles
  • Vincristine — DRUG
    Vincristine 1.4 mg/m2 (maximum of 2.0 mg total) IV intravenous on Day 1 of a 21-day treatment cycle for up to a total of 6 cycles
  • Prednisone — DRUG
    Prednisone 100 mg PO on Days 1 through 5 of each 21-day treatment or 100mg IV on Day 1 is also acceptable for up to a total of 6 cycles
  • CC-99282 — DRUG
    CC-99282 by mouth at the assigned dose starting on Day 1 for 7 consecutive days of the 21-day treatment cycle for 6 cycles of treatment.
  • Polatuzumab vedotin — DRUG
    Polatuzumab vedotin 1.8 mg/kg on Day 1 by intravenous (IV) infusion of a 21-day treatment cycle for up to a total of 6 cycles
  • Rituximab — DRUG
    Rituximab 375 mg/m2 on Day 1 by intravenous (IV) infusion of a 21-day treatment cycle for up to a total of 6 cycles

Study Details

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.

Key Dates

First listed
May 12, 2021
Start date
Sep 15, 2021
Status verified
Jul 2026
Primary completion
Dec 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
224 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Administration of CC-220 with R-CHOP-21
    CC-220 to be administered orally in combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP-21) for 6 cycles of treatment
  • Experimental: Administration of CC-99282 with R-CHOP-21
    CC-99282 to be administered orally in combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP-21) for 6 cycles of treatment
  • Experimental: Administration of CC-220 with polatuzumab-R-CHP
    CC-220 to be administered orally in combination with Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (polatuzumab-R-CHP) for 6 cycles of treatment
  • Experimental: Administration of CC-99282 with polatuzumab-R-CHP
    CC-99282 to be administered orally in combination with Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (polatuzumab-R-CHP) for 6 cycles of treatment

Primary Outcome Measure

Maximum Tolerated Dose (MTD) - Part 1 [ Time Frame: During the first 2 cycles of treatment (each cycle is 21 days) ]

Locations (15)

FacilityCityStateZIPSite coordinators
Local Institution - 162BirminghamAlabama35233-
Local Institution - 154ScottsdaleArizona85259-
Local Institution - 169DuarteCalifornia91010-
Local Institution - 160JacksonvilleFlorida32224-
Local Institution - 161MariettaGeorgia30060-
Local Institution - 159Kansas CityKansas66160-
Local Institution - 166WichitaKansas67214-
Local Institution - 152RochesterMinnesota55905-0001-
Local Institution - 163Saint Louis ParkMinnesota55426-
Local Institution - 151OmahaNebraska68198-
Local Institution - 170CharlotteNorth Carolina28204-
Local Institution - 164Winston-SalemNorth Carolina27157-
Local Institution - 155HoustonTexas77003-
Local Institution - 168MurrayUtah84107-
Local Institution - 171St. GeorgeUtah84790-

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