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ACTIVE NOT RECRUITING
NCT04884035
PHASE1

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

Sponsor: Celgene

View on ClinicalTrials.gov

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.

Official title: A Phase 1b, Open Label, Global, Multicenter, Dose Determination, Randomized Dose Expansion Study to Determine the Maximum Tolerated Dose, Assess the Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of Iberdomide (CC-220) in Combination With R-CHOP-21 and CC-99282 in Combination With R-CHOP-21 for Subjects With Previously Untreated Aggressive B-cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

224

Start Date

2021-09-15

Completion Date

2028-12-01

Last Updated

2026-07-20

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

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

DRUG

Cyclophosphamide

Cyclophosphamide 750mg/m2 on Day 1 by IV infusion of a 21-day treatment cycle for up to a total of 6 cycles

DRUG

Doxorubicin

Doxorubicin 50 mg/m2 IV infusion on Day 1 of a 21-day treatment cycle for up to a total of 6 cycles

DRUG

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

DRUG

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

DRUG

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.

DRUG

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

DRUG

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

Locations (36)

Local Institution - 162

Birmingham, Alabama, United States

Local Institution - 154

Scottsdale, Arizona, United States

Local Institution - 169

Duarte, California, United States

Local Institution - 160

Jacksonville, Florida, United States

Local Institution - 161

Marietta, Georgia, United States

Local Institution - 159

Kansas City, Kansas, United States

Local Institution - 166

Wichita, Kansas, United States

Local Institution - 152

Rochester, Minnesota, United States

Local Institution - 163

Saint Louis Park, Minnesota, United States

Local Institution - 151

Omaha, Nebraska, United States

Local Institution - 170

Charlotte, North Carolina, United States

Local Institution - 164

Winston-Salem, North Carolina, United States

Local Institution - 155

Houston, Texas, United States

Local Institution - 168

Murray, Utah, United States

Local Institution - 171

St. George, Utah, United States

Local Institution - 501

Adelaide, South Australia, 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, Poland

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