AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Venetoclax and Obinutuzumab Followed by Epcoritamab for the Treatment of Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, LonGEVity Trial

RecruitingPhase 2Ages 18 Years - anyAllCity of Hope Medical Center
💬

In plain words

What the trial is, and whether it could suit you

This phase II trial tests the effect of venetoclax and obinutuzumab followed by epcoritamab in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that have not previously received treatment. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Epcoritamab, a bispecific monoclonal antibody, binds to a protein called CD3, which is found on T cells (a type of white blood cell). It also binds to a protein called CD20, which is found on B cells (ano

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * Age: ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Histologically confirmed or flow cytometry confirmed diagnosis of B-CLL/SLL as documented by medical records and with histology based on criteria established by the World Health Organization (WHO) * No prior treatment for CLL/SLL, except steroids and/or rituximab to treat autoimmune complications * Evidence of CD20 positivity * Active disease meeting criteria for requiring treatment per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines * A minimum of any one of the following constitutional symptoms: * Unintentional weight loss \> 10% within the previous 6 months prior to screening * Extreme fatigue (unable to work or perform usual activities) * Fevers of greater than 100.5°F for ≥ 2 weeks without evidence of infection * Night sweats without evidence of infection * Evidence of progressive marrow failure as manifested by the development of, or worsening of anemia or thrombocytopenia * Massive (i.e., \> 6 cm below the left costal margin), progressive or symptomatic splenomegaly * Massive nodes or clusters (i.e., \> 10 cm in longest diameter) or progressive lymphadenopathy * Progressive lymphocytosis with an increase of \> 50% over a 2-month period, or an anticipated doubling time of less than 6 months * Autoimmune anemia or thrombocytopenia that is poorly responsive to corticosteroids * Symptomatic or functional extranodal involvement (e.g., skin, kidney, lung, spine) * Participant must be able to swallow tablets or capsules. A participant with any gastrointestinal disease that would impair ability to swallow, retain, or absorb drug is not eligible * Without bone marrow involvement: Absolute neutrophil count (ANC) ≥ 1,000/mm\^3 * NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement. * With bone marrow involvement: ANC ≥ 500/mm\^3 * NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement. * Without bone marrow involvement: Platelets ≥ 50,000/mm\^3 * NOTE: independent of transfusion support, with no active bleeding * With bone marrow involvement: Platelets ≥ 30,000/mm\^3 * NOTE: independent of transfusion support, with no active bleeding * Direct bilirubin ≤ 2 x upper limit of normal (ULN) (unless has Gilbert's disease or compensated hemolysis directly attributable to CLL) * Aspartate aminotransferase (AST) ≤ 2.5 x ULN * Alanine aminotransferase (ALT) ≤ 2.5 x ULN * Estimated creatinine clearance of ≥ 40 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2009 formula * If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN * If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants * If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN * If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants * Women of childbearing potential (WOCBP): Negative serum pregnancy test * Agreement by females of childbearing potential to either abstain from heterosexual activity or use an effective method of birth control (failure rate of \< 1% per year) during the treatment period and through at least 30 days after the last dose of venetoclax, 18 months after the last dose of obinutuzumab, 12 months after the last dose of epcoritamab, and at least 4 months after the last dose of tocilizumab (if applicable). Women must refrain from donating eggs during this same period * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) * Examples of contraceptive methods with a failure rate of \< 1% per year include tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices * Agreement by males to either abstain from heterosexual activity or use a condom during the treatment period and through at least 30 days after the last dose of venetoclax, 4 months after the last dose of obinutuzumab, epcoritamab or tocilizumab (as applicable). Men with a pregnant partner must agree to remain abstinent or use a condom for the duration of the pregnancy. Men must refrain from donating sperm during this same period Exclusion Criteria: * Chronic use of corticosteroids in excess of 20 mg/day prednisone or equivalent * Major surgery (under general anesthesia) within 30 days prior to cycle 1 day 1 (C1D1) * Uncontrolled coagulopathy or bleeding disorder. Direct oral anticoagulants are allowed * Exposure to vaccination with live vaccine within 30 days prior to C1D1, or anticipated need for such vaccination during treatment * Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (Richter's transformation) * Current evidence of central nervous system involvement by the CLL * History of confirmed progressive multifocal leukoencephalopathy (PML) * History of prior malignancy except: * Malignancy treated with curative intent and no known active disease present for ≥ 2 years prior to initiation of therapy on current study * Adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in situ) without evidence of disease * Adequately treated in situ carcinomas (e.g., cervical, esophageal, etc.) without evidence of disease * Asymptomatic prostate cancer managed with "watch and wait" strategy * Uncontrolled immune hemolysis or thrombocytopenia (positive direct antiglobulin test in absence of hemolysis or history of immune-mediated cytopenias are not exclusions) * Uncontrolled
💊

What it tests

  • Biospecimen Collection
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Computed Tomography
  • Electronic Health Record Review
📍

Where

7 sites
City of Hope Medical Center
Duarte, United States
City of Hope at Irvine Lennar
Irvine, United States
City of Hope at Long Beach Elm
Long Beach, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, United States
City of Hope Atlanta Cancer Center
Newnan, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, United States
Medical College of Wisconsin
Milwaukee, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy