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Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma
Sponsor: Celgene
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
Conditions
Interventions
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
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