Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon
BMS Recruiting Study icon

Recruiting

Trial ID CC-220-DLBCL-001  |   NCT04884035

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

Celgene Corporation, a wholly owned subsidiary of Bristol-Myers Squibb Company

Summary

  • Phase 1
  • Male and Female Gender icon
  • 18+
    Age Range
  • 18
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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.

Nearest Recruiting Site

Key Eligibility Criteria

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.

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Administration of CC-220 with polatuzumab-R-CHP

ASSIGNED INTERVENTION
  • Drug: Prednisone, Polatuzumab vedotin, Cyclophosphamide, Doxorubicin, CC-220, Rituximab

Study Arms

Experimental: Administration of CC-220 with R-CHOP-21

ASSIGNED INTERVENTION
  • Drug: Cyclophosphamide, CC-220, Prednisone, Doxorubicin, Vincristine, Rituximab

Study Arms

Experimental: Administration of CC-99282 with polatuzumab-R-CHP

ASSIGNED INTERVENTION
  • Drug: Cyclophosphamide, Doxorubicin, Rituximab, CC-99282, Polatuzumab vedotin, Prednisone

Study Arms

Experimental: Administration of CC-99282 with R-CHOP-21

ASSIGNED INTERVENTION
  • Drug: Rituximab, Cyclophosphamide, CC-99282, Vincristine, Prednisone, Doxorubicin
Take the first step to see if you Match to a Clinical Trial – Check Your Eligibility
Check Your Eligibility
Answer some questions about Your health to see if you may match to this trial
Match to a Trial
If you are a match, click on the study to see the list of study site locations
Select a Study Site Location
Select a study site location that is convenient for you
Register
Provide your contact details for the study site to connect with you.

Help us enhance your website experience! Share your feedback with our team at BMS Clinical Trials to improve yours and others’ experience. Thank you