Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
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

2026-06-08

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 (43)

University Hospital (University Of Alabama Hospital)

Birmingham, Alabama, United States

Mayo Clinic - Arizona

Scottsdale, Arizona, United States

City Of Hope National Medical Center

Duarte, California, United States

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Mayo Clinic Jacksonville - PPDS

Jacksonville, Florida, United States

Northwest Georgia Oncology Centers PC

Marietta, Georgia, 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

Levine Cancer Institute

Charlotte, North Carolina, United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

MD Anderson Cancer Center

Houston, Texas, United States

Intermountain Medical Oncology

Murray, Utah, United States

Intermountain Cancer Center - St George

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