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
Rechercher Study Connect

Recruiting

Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma - CC-220-DLBCL-001

Mis à jour: 20 février, 2024   |   ClinicalTrials.gov

Celgene Corporation, filiale entièrement détenue par Bristol-Myers Squibb Company 

Résumé imprimable

VOUS ENVISAGEZ CET ESSAI ?
Imprimer cette page et le guide d’essai pour vous aider à parler avec votre médecin.
Utiliser le Guide du participant à l’étude pour découvrir comment participer à un essai clinique. Comprendre les principaux facteurs à envisager avant de prendre une décision et poser des questions à votre équipe soignante.

Détails de l’essai

  • Phase 1

    Phase

  • Sexe(s)

  • 18+

    Tranche d’âge

  • 18

    Site(s)

  • Recruiting

Options de traitement

Bras de l’étude
INTERVENTION ASSIGNÉE
Experimental: Administration of CC-220 with polatuzumab-R-CHP
Drug: CC-220, Cyclophosphamide, Rituximab, Prednisone, Polatuzumab vedotin, Doxorubicin
Experimental: Administration of CC-220 with R-CHOP-21
Drug: CC-220, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
Experimental: Administration of CC-99282 with polatuzumab-R-CHP
Drug: Cyclophosphamide, Doxorubicin, Rituximab, CC-99282, Polatuzumab vedotin, Prednisone
Experimental: Administration of CC-99282 with R-CHOP-21
Drug: Rituximab, Cyclophosphamide, CC-99282, Vincristine, Prednisone, Doxorubicin

Principaux critères d’éligibilité

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 poor-risk disease defined as International Prognostic Index (IPI) score ≥ 3 (high-intermediate or high-risk). 4. Participants must have measurable disease defined by at least one FDG-avid lesion for FDGavid 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 syndrome, then ≤ 5.0 mg/dl 6. Estimated serum creatinine clearance of ≥ 50 mL/min 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. Chronic systemic immunosuppressive therapy or corticosteroids 8. 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 scan (MUGA) or echocardiogram (ECHO) 9. Major surgery ≤ 2 weeks prior to starting CC-220 or CC-99282; participant must have recovered from any clinically significant effects of recent surgery. 10. Any condition causing inability to swallow tablets. 11. Known seropositivity for or active viral infection with human immunodeficiency virus (HIV) 12. Known chronic active hepatitis B (hepatitis B 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 13. 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. 14. Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients of rituximab. 15. Known hypersensitivity to any component of CHOP regimen. 16. Known allergy to thalidomide, pomalidomide, or lenalidomide.

Nous vous recommandons vivement de contacter BMS pour signaler les effets secondaires (événements indésirables)
Les effets secondaires (événements indésirables) et les autres événements à signaler sont définis ici
Signaler des plaintes concernant des effets indésirables (effets indésirables) ou des produits: Informations médicales