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Lymphoma, B-CellPhase 1NCT04884035

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

A Phase 1 study testing CC-220, Rituximab and Cyclophosphamide in people with Lymphoma, B-Cell, run by Celgene at 36 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, B-Cell
What is being tested?
CC-220, Rituximab and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
36 sitesin 7 countries
Study dates
15 Sep 2021to 1 Dec 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must satisfy the following criteria to be enrolled in the study:
  • Is ≥ 18 years of age at the time of signing the informed consent form (ICF).
  • Participant has histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated, a-BCL according to 2016 WHO classification.
  • Participant has International Prognostic Index (IPI) score 0-5 in Part 1 and IPI 2-5 in Part 2. For the CELMoD and polatuzumab-R-CHP cohort, the subject must also have IPI score 0 to 5 in Part 2A and IPI 2 to 5 in Part 2B.
  • Participants must have measurable disease defined by at least one FDG-avid lesion for FDG-avid subtype and one bi-dimensionally measurable (> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification (Cheson, 2014).
  • Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
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  • Participants must have the following laboratory values:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L or ≥ 1.0 x 109/L in case of documented bone marrow involvement (> 50% or tumor cells), without growth factor support for 7 days (14 days if peg-G-CSF)
  • Hemoglobin (Hb) ≥ 8 g/dL
  • Platelets (PLT) ≥ 75 x 109/L or ≥ 50 x 109/L in case of documented bone marrow involvement (>50% or tumor cells), without transfusion for 7 days
  • Aspartate aminotransferase / serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase / serum glutamate pyruvic transaminase (ALT/SGPT) ≤ 2.5 x upper limit of normal (ULN). In the case of documented liver involvement by lymphoma, ALT/SGPT and AST/SGOT must be ≤ 5.0 x ULN.
  • Serum total bilirubin ≤ 2.0 mg/dL except in cases of Gilbert's syndrome, then ≤ 5.0 mg/dl. Subjects receiving polatuzumab vedotin must have serum total bilirubin < 1.5 × ULN (26 μmol/L) (corresponding to mild degree as per National Cancer Institute Organ Dysfunction Working Group [NCI ODWG] criteria) except in cases of Gilbert's syndrome, then ≤ 3.0 mg/dl (51 μmol/L).
  • Estimated serum creatinine clearance (CrCl) of ≥ 50 mL/min using the modification of diet in renal disease (MDRD) formula.
  • All participants must:
  • Have an understanding that the study drug could have a potential teratogenic risk.
  • Agree to follow all requirements defined in the Pregnancy Prevention Program for CC-220 or CC-99282 Pregnancy Prevention Plan for Participants in Clinical trials.
  • Females of childbearing potential (FCBP) must:
  • Have two negative pregnancy tests as verified by the investigator prior to starting study therapy.
  • Male participants must:
  • Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study.

Who cannot join

  • The presence of any of the following will exclude a participant from enrollment:
  • Any significant medical condition, active infection (including SARS-CoV-2 suspected or confirmed), laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
  • Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study.
  • Any other subtype of lymphoma.
  • Documented or suspected CNS involvement by lymphoma.
  • Persistent diarrhea or malabsorption ≥ Grade 2 (NCI CTCAE v5.0), despite medical management.
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  • Peripheral neuropathy ≥ Grade 2 (NCI CTCAE v5.0).
  • Subjects with a history of progressive multifocal leukoencephalopathy.
  • Chronic systemic immunosuppressive therapy or corticosteroids
  • Impaired cardiac function or clinically significant cardiac disease, including any of the following:
  • Left ventricular ejection fraction (LVEF) < 45% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO)
  • Major surgery ≤ 2 weeks prior to starting CC-220 or CC-99282; participant must have recovered from any clinically significant effects of recent surgery.
  • Any condition causing inability to swallow tablets.
  • Known seropositivity for or active viral infection with human immunodeficiency virus (HIV)
  • Known chronic active hepatitis B (hepatitis B virus surface antigen [HBsAg] positive and/or hepatitis B core antibody [anti-HBc] positive with viral DNA positive) or C (positive serology requiring treatment and/or with evidence of liver damage) infection
  • History of other malignancy, unless being free of the disease for ≥ 3 years; exceptions to the ≥ 3-year time limit include history of the following:
  • Localized nonmelanoma skin cancer
  • Carcinoma in situ of the cervix
  • Carcinoma in situ of the breast
  • Incidental histologic finding of prostate cancer (T1a or T1b as per Tumor Node Metastasis [TNM] staging system) or prostate cancer that has been treated with curative intent.
  • Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients of rituximab or polatuzumab vedotin.
  • Known hypersensitivity to any component of CHOP/CHP regimen.
  • Known allergy to thalidomide, pomalidomide, or lenalidomide.

Trial locations and contacts

36 sites in 7 countries.

36 sites in 7 countries

United States15 sites

  • Local Institution - 162

    Birmingham, Alabama, 35233

  • Local Institution - 170

    Charlotte, North Carolina, 28204

  • Local Institution - 169

    Duarte, California, 91010

  • Local Institution - 155

    Houston, Texas, 77003

  • Local Institution - 160

    Jacksonville, Florida, 32224

  • Local Institution - 159

    Kansas City, Kansas, 66160

  • Local Institution - 161

    Marietta, Georgia, 30060

  • Local Institution - 168

    Murray, Utah, 84107

  • Local Institution - 151

    Omaha, Nebraska, 68198

  • Local Institution - 152

    Rochester, Minnesota, 55905-0001

  • Local Institution - 163

    Saint Louis Park, Minnesota, 55426

  • Local Institution - 154

    Scottsdale, Arizona, 85259

  • Local Institution - 171

    St. George, Utah, 84790

  • Local Institution - 166

    Wichita, Kansas, 67214

  • Local Institution - 164

    Winston-Salem, North Carolina, 27157

Other trials in United States

Poland6 sites

  • Local Institution - 601

    Gdansk, 80-952

  • Local Institution - 600

    Krakow, 30-727

  • Local Institution - 605

    Skórzewo, Greater Poland Voivodeship, 60-185

  • Local Institution - 603

    Słomniki, 32-090

  • Local Institution - 602

    Warsaw, 02-781

  • Local Institution - 604

    Wroclaw, 50-367

Other trials in Poland

Greece4 sites

  • Local Institution - 702

    Athens, 10676

  • Local Institution - 704

    Athens, 11 527

  • Local Institution - 701

    Athens, 12464

  • Local Institution - 700

    Thessaloniki, 57010

Other trials in Greece

South Korea3 sites

  • Local Institution - 300

    Seoul, 06351

  • Local Institution - 302

    Seoul, 138-736

  • Local Institution - 301

    Seoul, 3080

Other trials in South Korea

Spain3 sites

  • Local Institution - 201

    Barcelona, 08916

  • Local Institution - 203

    Málaga, 29010

  • Local Institution - 200

    Salamanca, 37007

Other trials in Spain

Taiwan3 sites

  • Local Institution - 403

    Taichung, 40447

  • Local Institution - 402

    Taichung, 407

  • Local Institution - 400

    Taipei, 100229

Other trials in Taiwan

Australia2 sites

  • Local Institution - 501

    Adelaide, South Australia, 5000

  • Local Institution - 503

    Perth, WA 6000

Other trials in Australia

About this study

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

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.

Keywords
Iberdomide, CC-220, CC-99282, Phase 1, B-Cell Lymphoma
Medical subject headings
Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CC-220Drug

    Also called Iberdomide, BMS-986382

    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.

  • RituximabDrug

    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

  • CyclophosphamideDrug

    Cyclophosphamide 750mg/m2 on Day 1 by IV infusion of a 21-day treatment cycle for up to a total of 6 cycles

  • DoxorubicinDrug

    Doxorubicin 50 mg/m2 IV infusion on Day 1 of a 21-day treatment cycle for up to a total of 6 cycles

  • VincristineDrug

    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

  • PrednisoneDrug

    Also called Prednisolone

    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-99282Drug

    Also called BMS-986369

    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 vedotinDrug

    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

  • RituximabDrug

    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

Study groups in NCT04884035
Study groupRoleWhat they receive
Administration of CC-220 with R-CHOP-21ExperimentalCC-220 to be administered orally in combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP-21) for 6 cycles of treatment
Receives: Drug: CC-220; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone
Administration of CC-99282 with R-CHOP-21ExperimentalCC-99282 to be administered orally in combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP-21) for 6 cycles of treatment
Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: CC-99282
Administration of CC-220 with polatuzumab-R-CHPExperimentalCC-220 to be administered orally in combination with Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (polatuzumab-R-CHP) for 6 cycles of treatment
Receives: Drug: CC-220; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone; Drug: Polatuzumab vedotin; Drug: Rituximab
Administration of CC-99282 with polatuzumab-R-CHPExperimentalCC-99282 to be administered orally in combination with Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (polatuzumab-R-CHP) for 6 cycles of treatment
Receives: Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone; Drug: CC-99282; Drug: Polatuzumab vedotin; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD) - Part 1

    Frequency of dose-limiting toxicities (DLT) associated with addition of iberdomide (CC-220) to R-CHOP-21 therapy and the addition of CC-99282 to R-CHOP-21 therapy

    Measured: During the first 2 cycles of treatment (each cycle is 21 days)

  2. Recommended Phase 2 Dose (RP2D) - Part 1

    Defined as the dose that will be selected for dose expansion based on MTD

    Measured: During the first cycle of treatment (each cycle is 21 days)

  3. Safety and tolerability of CC-220 and CC-99282 at RP2D - Part 2

    AEs evaluated using NCI CTCAE criteria, v. 5.0, including treatment -emergent adverse events (TEAEs) and laboratory assessments

    Measured: From the first dose of any IP until 28 days after the last dose of IP

  4. Maximum Tolerated Dose (MTD) - Part 2A

    Frequency of DLTs associated with addition of iberdomide (CC-220) to polatuzumab-R-CHP therapy and the addition of CC-99282 to polatuzumab-R-CHP therapy

    Measured: During the first cycle of treatment (each cycle is 21 days)

  5. Recommended Phase 2 Dose (RP2D) - Part 2A

    Defined as the dose that will be selected for dose expansion based on MTD

    Measured: During the first cycle of treatment (each cycle is 21 days)

Secondary outcomes (12)

  1. Best overall response rate (ORR)

    The proportion of participants with best overall response achieved during the study as either Complete Response or Partial Response before subsequent anti-lymphoma therapy

    Measured: Up to 4 years

  2. Complete Metabolic Response Rate (CMRR)

    The proportion of participants experiencing complete metabolic response (CMR) before receiving any subsequent anti-lymphoma therapy

    Measured: Up to 4 years

  3. Time to Response (TTR)

    The time from entry to the study (enrollment date for Part 1 and randomization date for Part 2) to the date of first documented response (≥ PR)

    Measured: Up to 4 years

  4. Duration of Response (DOR)

    The time from the earliest date of documented response (≥ PR) to the first occurrence of relapse or progression

    Measured: Up to 4 years

  5. Progression-free Survival (PFS)

    The time from entry to the study (enrollment date for Part 1 and randomization date for Part 2) to the first occurrence of disease progression or death from any cause

    Measured: Up to 4 years

  6. Overall Survival (OS)

    The time from entry to the study (enrollment date for Part 1 and randomization date for Part 2) to death from any cause

    Measured: Up to 4 years

  7. Pharmacokinetics - Cmax for CC-220

    Maximum plasma concentration of drug

    Measured: At Cycle 1 Day 7, Cycle 1 Day 15, and Cycle 2 Day 7 (each cycle is 21 days)

  8. Pharmacokinetics - Ctrough for CC-220

    Minimum or trough concentration

    Measured: At Cycle 1 Day 7, Cycle 1 Day 15, and Cycle 2 Day 7 (each cycle is 21 days

  9. Pharmacokinetics - Tmax for CC-220

    Time to maximum plasma concentration

    Measured: At Cycle 1 Day 7, Cycle 1 Day 15, and Cycle 2 Day 7 (each cycle is 21 days

  10. Pharmacokinetics - Cmax for CC-99282

    Maximum plasma concentration

    Measured: At Cycle 1 Day 7, Cycle 1 Day 15, and Cycle 2 Day 7 (each cycle is 21 days

  11. Pharmacokinetics - Ctrough for CC-99282

    Minimum or trough concentration

    Measured: At Cycle 1 Day 7, Cycle 1 Day 15, and Cycle 2 Day 7 (each cycle is 21 days

  12. Pharmacokinetics - Tmax for CC-99282

    Time to maximum plasma concentration

    Measured: At Cycle 1 Day 7, Cycle 1 Day 15, and Cycle 2 Day 7 (each cycle is 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2021
  2. Study start15 Sep 2021
  3. Primary completion1 Dec 2028 (estimated)
  4. Study completion1 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
224 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04884035
Sponsor's protocol ID
CC-220-DLBCL-001
Other IDs
2023-506094-35, 2023
Status last verified
Jul 2026
First submitted
7 May 2021
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Publications

  • Wu C, Meyer A, Tun AM. Diffuse Large B-Cell Lymphoma Presenting in a Background of Rosai-Dorfman Disease. Case Rep Hematol. 2026 May 17;2026:6560267. doi: 10.1155/crh/6560267. eCollection 2026.

    PubMed 42158929

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CC-220, Rituximab and Cyclophosphamide in people with Lymphoma, B-Cell, run by Celgene at 36 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, Poland, Greece, South Korea, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) - Part 1 (time frame: During the first 2 cycles of treatment (each cycle is 21 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04884035, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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