Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma
Condition(s) studied
Investigational drug(s) / intervention(s)
CC-220: 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: 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: Cyclophosphamide 750mg/m2 on Day 1 by IV infusion of a 21-day treatment cycle for up to a total of 6 cycles
Doxorubicin: Doxorubicin 50 mg/m2 IV infusion on Day 1 of a 21-day treatment cycle for up to a total of 6 cycles
Vincristine: 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: 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: 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: 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: 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 summary
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.
Eligibility
Primary outcome measure(s)
- Maximum Tolerated Dose (MTD) - Part 1 — During the first 2 cycles of treatment (each cycle is 21 days)
Frequency of dose-limiting toxicities (DLT) associated with addition of iberdomide (CC-220) to R-CHOP-21 therapy and the addition of CC-99282 to R-CHOP-21 therapy - Recommended Phase 2 Dose (RP2D) - Part 1 — During the first cycle of treatment (each cycle is 21 days)
Defined as the dose that will be selected for dose expansion based on MTD - Safety and tolerability of CC-220 and CC-99282 at RP2D - Part 2 — From the first dose of any IP until 28 days after the last dose of IP
AEs evaluated using NCI CTCAE criteria, v. 5.0, including treatment -emergent adverse events (TEAEs) and laboratory assessments - Maximum Tolerated Dose (MTD) - Part 2A — During the first cycle of treatment (each cycle is 21 days)
Frequency of DLTs associated with addition of iberdomide (CC-220) to polatuzumab-R-CHP therapy and the addition of CC-99282 to polatuzumab-R-CHP therapy - Recommended Phase 2 Dose (RP2D) - Part 2A — During the first cycle of treatment (each cycle is 21 days)
Defined as the dose that will be selected for dose expansion based on MTD
Trial sites (36)
| Facility | City | Region | Status |
|---|---|---|---|
| Local Institution - 162 | Birmingham | Alabama | |
| Local Institution - 154 | Scottsdale | Arizona | |
| Local Institution - 169 | Duarte | California | |
| Local Institution - 160 | Jacksonville | Florida | |
| Local Institution - 161 | Marietta | Georgia | |
| Local Institution - 159 | Kansas City | Kansas | |
| Local Institution - 166 | Wichita | Kansas | |
| Local Institution - 152 | Rochester | Minnesota | |
| Local Institution - 163 | Saint Louis Park | Minnesota | |
| Local Institution - 151 | Omaha | Nebraska | |
| Local Institution - 170 | Charlotte | North Carolina | |
| Local Institution - 164 | Winston-Salem | North Carolina | |
| Local Institution - 155 | Houston | Texas | |
| Local Institution - 168 | Murray | Utah | |
| Local Institution - 171 | St. George | Utah | |
| Local Institution - 501 | Adelaide | South Australia | |
| Local Institution - 503 | Perth | Australia | |
| Local Institution - 702 | Athens | Greece | |
| Local Institution - 704 | Athens | Greece | |
| Local Institution - 701 | Athens | Greece | |
| Local Institution - 700 | Thessaloniki | Greece | |
| Local Institution - 605 | Skórzewo | Greater Poland Voivodeship | |
| Local Institution - 601 | Gdansk | Poland | |
| Local Institution - 600 | Krakow | Poland | |
| Local Institution - 603 | Słomniki | Poland | |
| Local Institution - 602 | Warsaw | Poland | |
| Local Institution - 604 | Wroclaw | Poland | |
| Local Institution - 300 | Seoul | South Korea | |
| Local Institution - 302 | Seoul | South Korea | |
| Local Institution - 301 | Seoul | South Korea | |
| Local Institution - 201 | Barcelona | Spain | |
| Local Institution - 203 | Málaga | Spain | |
| Local Institution - 200 | Salamanca | Spain | |
| Local Institution - 403 | Taichung | Taiwan | |
| Local Institution - 402 | Taichung | Taiwan | |
| Local Institution - 400 | Taipei | Taiwan |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04884035 on ClinicalTrials.gov ↗ ← All trials in South Korea