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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

174

Start Date

2021-09-15

Completion Date

2028-12-01

Last Updated

2026-02-04

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 (40)

Mayo Clinic - Arizona

Scottsdale, Arizona, United States

Local Institution - 169

Duarte, California, United States

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Mayo Clinic Jacksonville - PPDS

Jacksonville, Florida, United States

University Of Kansas Medical Center

Kansas City, Kansas, United States

Cancer Center Of Kansas-Wichita

Wichita, Kansas, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

HealthPartners Cancer Research Center

Saint Louis Park, Minnesota, United States

University of Nebraska - Fred and Pamela Buffet Center

Omaha, Nebraska, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Local Institution - 170

Charlotte, North Carolina, United States

MD Anderson Cancer Center

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 - 502

Waratah, Australia

Evangelismos General Hospital of Athens

Athens, Greece

General Hospital of Athens "Laiko"

Athens, Greece

Attikon University General Hospital

Athens, Greece

Local Institution - 703

Pátrai, Greece

Georgios Papanikolaou General Hospital of Thessaloniki

Thessaloniki, Greece

AIDPORT Sp. z o.o.

Skórzewo, Greater Poland Voivodeship, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

MCM Krakow - PRATIA - PPDS

Krakow, Poland

Local Institution - 0706

Poznan, Poland

Local Institution - UNK0706

Poznan, Poland

SP ZOZ Szpital Uniwersytecki w Krakowie

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

Hospital Universitari Germans Trias i Pujol ICO Badalona

Barcelona, Spain

Local Institution - 204

Madrid, Spain

H. Virgen de la Victoria

Málaga, Spain

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

Salamanca, Spain

China Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan