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
Recruiting
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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

Start date
Sep 15, 2021
Status verified
Jun 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) ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (17)

FacilityCityStateZIPSite coordinators
University Hospital (University Of Alabama Hospital)BirminghamAlabama35233
Aditi Saha, Site 162
Mayo Clinic - ArizonaScottsdaleArizona85259
Javier Munoz, Site 154
000-000-0000
City Of Hope National Medical CenterDuarteCalifornia91010
Geoffrey Shouse, Site 169
626-218-7478
Mayo Clinic - JacksonvilleJacksonvilleFlorida32224-
Mayo Clinic Jacksonville - PPDSJacksonvilleFlorida32224
Muhamad Alhaj Moustafa, Site 160
904-953-2000
Northwest Georgia Oncology Centers PCMariettaGeorgia30060
Dean Kirkel, Site 161
770-281-5100
University Of Kansas Medical CenterKansas CityKansas66160
Marc Hoffmann, Site 159
913-574-2650
Cancer Center Of Kansas-WichitaWichitaKansas67214
Shaker Dakhil, Site 166
316-262-4467
Mayo Clinic - RochesterRochesterMinnesota55905-0001
Grzegorz Nowakowski, Site 152
507-284-2511
HealthPartners Cancer Research CenterSaint Louis ParkMinnesota55426
Gordon Ruan, Site 163
University of Nebraska - Fred and Pamela Buffet CenterOmahaNebraska68198
Matthew Lunning, Site 151
402-559-7164
Roswell Park Cancer InstituteBuffaloNew York14263-
Levine Cancer InstituteCharlotteNorth Carolina28204
Rakhee Vaidya, Site 170
Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27157
Rakhee Vaidya, Site 164
336-713-5440
MD Anderson Cancer CenterHoustonTexas77003
Jason Westin, Site 155
713-792-3750
Intermountain Medical OncologyMurrayUtah84107
Rachel Hu, Site 168
Intermountain Cancer Center - St GeorgeSt. GeorgeUtah84790
Rachel Hu, Site 171

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