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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
174
Start Date
2021-09-15
Completion Date
2028-12-01
Last Updated
2026-02-04
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 (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