Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT04884035

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

Led by Celgene · Updated on 2026-04-17

224

Participants Needed

42

Research Sites

376 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be 18 years or older at the time of consent
  • Histologically confirmed diagnosis of de novo, previously untreated aggressive B-cell lymphoma
  • International Prognostic Index (IPI) score 0-5 in Part 1 and IPI 2-5 in Part 2
  • Measurable disease with at least one FDG-avid lesion or bi-dimensionally measurable disease by CT or MRI
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Adequate laboratory values including neutrophil count, hemoglobin, platelets, liver enzymes, bilirubin, and creatinine clearance
  • Understanding and agreement to follow the Pregnancy Prevention Program for study drugs
  • Females of childbearing potential must have two negative pregnancy tests before starting therapy
  • Male participants must practice true abstinence or use a condom during sexual contact with pregnant females or females of childbearing potential
Not Eligible

You will not qualify if you...

  • Significant medical conditions, active infections including COVID-19, or psychiatric illnesses preventing study participation
  • Conditions or laboratory abnormalities placing participant at unacceptable risk
  • Other lymphoma subtypes besides aggressive B-cell lymphoma
  • Documented or suspected central nervous system involvement by lymphoma
  • Persistent diarrhea or malabsorption grade 2 or higher despite treatment
  • Peripheral neuropathy grade 2 or higher
  • History of progressive multifocal leukoencephalopathy
  • Chronic systemic immunosuppressive therapy or corticosteroids
  • Impaired cardiac function or significant cardiac disease including LVEF below 45%
  • Major surgery within 2 weeks before starting study drugs without full recovery
  • Inability to swallow tablets
  • Known HIV infection
  • Known chronic active hepatitis B or C infection
  • History of other malignancy unless disease-free for 3 years, with some exceptions
  • Hypersensitivity to study drugs or related compounds
  • Known allergy to thalidomide, pomalidomide, or lenalidomide

AI-Screening

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Trial Site Locations

Total: 42 locations

1

Local Institution - 162

Birmingham, Alabama, United States, 35233

Not Yet Recruiting

2

Mayo Clinic - Arizona

Scottsdale, Arizona, United States, 85259

Actively Recruiting

3

Local Institution - 169

Duarte, California, United States, 91010

Not Yet Recruiting

4

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States, 32224

Withdrawn

5

Mayo Clinic Jacksonville - PPDS

Jacksonville, Florida, United States, 32224

Actively Recruiting

6

Local Institution - 161

Marietta, Georgia, United States, 30060

Not Yet Recruiting

7

University Of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

8

Cancer Center Of Kansas-Wichita

Wichita, Kansas, United States, 67214

Actively Recruiting

9

Mayo Clinic - Rochester

Rochester, Minnesota, United States, 55905-0001

Actively Recruiting

10

HealthPartners Cancer Research Center

Saint Louis Park, Minnesota, United States, 55426

Actively Recruiting

11

University of Nebraska - Fred and Pamela Buffet Center

Omaha, Nebraska, United States, 68198

Actively Recruiting

12

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Withdrawn

13

Local Institution - 170

Charlotte, North Carolina, United States, 28204

Not Yet Recruiting

14

MD Anderson Cancer Center

Houston, Texas, United States, 77003

Actively Recruiting

15

Local Institution - 168

Murray, Utah, United States, 84107

Not Yet Recruiting

16

Local Institution - 171

St. George, Utah, United States, 84790

Not Yet Recruiting

17

Local Institution - 501

Adelaide, South Australia, Australia, 5000

Completed

18

Local Institution - 503

Perth, Australia, WA 6000

Completed

19

Local Institution - 502

Waratah, Australia, NSW

Withdrawn

20

Evangelismos General Hospital of Athens

Athens, Greece, 10676

Actively Recruiting

21

General Hospital of Athens "Laiko"

Athens, Greece, 11 527

Actively Recruiting

22

Attikon University General Hospital

Athens, Greece, 12464

Actively Recruiting

23

Local Institution - 703

Pátrai, Greece, 26500

Withdrawn

24

Georgios Papanikolaou General Hospital of Thessaloniki

Thessaloniki, Greece, 57010

Actively Recruiting

25

AIDPORT Sp. z o.o.

Skórzewo, Greater Poland Voivodeship, Poland, 60-185

Actively Recruiting

26

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland, 80-952

Actively Recruiting

27

MCM Krakow - PRATIA - PPDS

Krakow, Poland, 30-727

Actively Recruiting

28

Local Institution - 0706

Poznan, Poland, 60-185

Withdrawn

29

Local Institution - UNK0706

Poznan, Poland, 60-185

Withdrawn

30

SP ZOZ Szpital Uniwersytecki w Krakowie

Słomniki, Poland, 32-090

Actively Recruiting

31

Local Institution - 602

Warsaw, Poland, 02-781

Actively Recruiting

32

Local Institution - 604

Wroclaw, Poland, 50-367

Completed

33

Local Institution - 300

Seoul, South Korea, 06351

Completed

34

Local Institution - 302

Seoul, South Korea, 138-736

Completed

35

Local Institution - 301

Seoul, South Korea, 3080

Completed

36

Hospital Universitari Germans Trias i Pujol ICO Badalona

Barcelona, Spain, 08916

Actively Recruiting

37

Local Institution - 204

Madrid, Spain, 28028

Withdrawn

38

H. Virgen de la Victoria

Málaga, Spain, 29010

Actively Recruiting

39

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

Salamanca, Spain, 37007

Actively Recruiting

40

China Medical University Hospital

Taichung, Taiwan, 40447

Actively Recruiting

41

Taichung Veterans General Hospital

Taichung, Taiwan, 407

Actively Recruiting

42

National Taiwan University Hospital

Taipei, Taiwan, 100229

Actively Recruiting

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Research Team

B

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

F

First line of the email MUST contain NCT # and Site #.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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