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New drug combo aims to boost lymphoma treatment

NCT ID NCT04884035

Disease control Sponsor: Celgene Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times

Summary

This early-stage study tests whether adding either iberdomide or CC-99282 to standard chemotherapy (R-CHOP) can safely treat people with untreated aggressive B-cell lymphoma. About 224 adults will take part. The main goals are to find the best dose and check for side effects, while also looking at how well the tumors respond.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 224 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants must satisfy the following criteria to be enrolled in the study: 1. Is ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Participant has histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated, a-BCL according to 2016 WHO classification. 3. 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. 4. 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). 5. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 6. Participants must have the following laboratory values: 1. 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) 2. Hemoglobin (Hb) ≥ 8 g/dL 3. 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 4. 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. 5. 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). 6. Estimated serum creatinine clearance (CrCl) of ≥ 50 mL/min using the modification of diet in renal disease (MDRD) formula. 7. All participants must: 1. Have an understanding that the study drug could have a potential teratogenic risk. 2. 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. 8. Females of childbearing potential (FCBP) must: a. Have two negative pregnancy tests as verified by the investigator prior to starting study therapy. 9. Male participants must: 1. 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. Exclusion Criteria: * The presence of any of the following will exclude a participant from enrollment: 1. 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. 2. Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study. 3. Any other subtype of lymphoma. 4. Documented or suspected CNS involvement by lymphoma. 5. Persistent diarrhea or malabsorption ≥ Grade 2 (NCI CTCAE v5.0), despite medical management. 6. Peripheral neuropathy ≥ Grade 2 (NCI CTCAE v5.0). 7. Subjects with a history of progressive multifocal leukoencephalopathy. 8. Chronic systemic immunosuppressive therapy or corticosteroids 9. Impaired cardiac function or clinically significant cardiac disease, including any of the following: a. Left ventricular ejection fraction (LVEF) \< 45% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO) 10. Major surgery ≤ 2 weeks prior to starting CC-220 or CC-99282; participant must have recovered from any clinically significant effects of recent surgery. 11. Any condition causing inability to swallow tablets. 12. Known seropositivity for or active viral infection with human immunodeficiency virus (HIV) 13. 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 14. 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: 1. Localized nonmelanoma skin cancer 2. Carcinoma in situ of the cervix 3. Carcinoma in situ of the breast 4. 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. 15. Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients of rituximab or polatuzumab vedotin. 16. Known hypersensitivity to any component of CHOP/CHP regimen. 17. Known allergy to thalidomide, pomalidomide, or lenalidomide.

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Conditions

The condition(s) this trial relates to.

aggressive B-cell non-Hodgkin lymphoma B-cell neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphoma, B-cell

Contacts and locations

Locations

  • Local Institution - 151

    Omaha, Nebraska, 68198, United States

  • Local Institution - 152

    Rochester, Minnesota, 55905-0001, United States

  • Local Institution - 154

    Scottsdale, Arizona, 85259, United States

  • Local Institution - 155

    Houston, Texas, 77003, United States

  • Local Institution - 159

    Kansas City, Kansas, 66160, United States

  • Local Institution - 160

    Jacksonville, Florida, 32224, United States

  • Local Institution - 161

    Marietta, Georgia, 30060, United States

  • Local Institution - 162

    Birmingham, Alabama, 35233, United States

  • Local Institution - 163

    Saint Louis Park, Minnesota, 55426, United States

  • Local Institution - 164

    Winston-Salem, North Carolina, 27157, United States

  • Local Institution - 166

    Wichita, Kansas, 67214, United States

  • Local Institution - 168

    Murray, Utah, 84107, United States

  • Local Institution - 169

    Duarte, California, 91010, United States

  • Local Institution - 170

    Charlotte, North Carolina, 28204, United States

  • Local Institution - 171

    St. George, Utah, 84790, United States

  • Local Institution - 200

    Salamanca, 37007, Spain

  • Local Institution - 201

    Barcelona, 08916, Spain

  • Local Institution - 203

    Málaga, 29010, Spain

  • Local Institution - 300

    Seoul, 06351, South Korea

  • Local Institution - 301

    Seoul, 3080, South Korea

  • Local Institution - 302

    Seoul, 138-736, South Korea

  • Local Institution - 400

    Taipei, 100229, Taiwan

  • Local Institution - 402

    Taichung, 407, Taiwan

  • Local Institution - 403

    Taichung, 40447, Taiwan

  • Local Institution - 501

    Adelaide, South Australia, 5000, Australia

  • Local Institution - 503

    Perth, WA 6000, Australia

  • Local Institution - 600

    Krakow, 30-727, Poland

  • Local Institution - 601

    Gdansk, 80-952, Poland

  • Local Institution - 602

    Warsaw, 02-781, Poland

  • Local Institution - 603

    Słomniki, 32-090, Poland

  • Local Institution - 604

    Wroclaw, 50-367, Poland

  • Local Institution - 605

    Skórzewo, Greater Poland Voivodeship, 60-185, Poland

  • Local Institution - 700

    Thessaloniki, 57010, Greece

  • Local Institution - 701

    Athens, 12464, Greece

  • Local Institution - 702

    Athens, 10676, Greece

  • Local Institution - 704

    Athens, 11 527, Greece

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