menu

ReachMD

Be part of the knowledge.
Register

We’re glad to see you’re enjoying ReachMD…
but how about a more personalized experience?

Register for free

Updates in CLL Treatment: 5 Year Follow-up Data from the CLL14 Trial

Details
Recommended

Overview

ReachMD Healthcare Image
RestartResume

What do clinicians need to know about the CLL14 trial? Tune into this episode.

  • Sponsored by

  • Overview

    Review of the primary analysis and the five-year update of the CLL14 trial studying fixed-duration venetoclax-obinutuzumab in treating patients with chronic lymphocytic leukemia (CLL). To walk us through the data, Dr. John Russell is joined by Dr. Joanna Rhodes, Director of Lymphoma at Rutgers Cancer Institute of New Jersey in New Brunswick, NJ.

     

     

  • Venetoclax Indication and Safety Overview

    Indication 

    • Venetoclax is a BCL-2 inhibitor indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

    Contraindications

    • Strong CYP3A Inhibitors: Concomitant use with strong CYP3A inhibitors at initiation and during ramp-up phase in patients with CLL/SLL is contraindicated.

    Warnings and Precautions

    • TLS: Tumor lysis syndrome (TLS), including fatal events and renal failure requiring dialysis, has occurred in patients treated with venetoclax. Anticipate TLS; assess risk in all patients. Premedicate with anti-hyperuricemics and ensure adequate hydration. Employ more intensive measures (intravenous hydration, frequent monitoring, hospitalization) as overall risk increases.
    • Neutropenia: Monitor blood counts. Interrupt dosing and resume at same or reduced dose. Consider supportive care measures.
    • Infections: Fatal and serious infections such as pneumonia and sepsis have occurred in patients treated with venetoclax. Monitor patients for signs and symptoms of infection and treat promptly. Withhold venetoclax for Grade 3 and 4 infection until resolution and resume at same or reduced dose.
    • Immunization: Do not administer live attenuated vaccines prior to, during, or after venetoclax treatment until B-cell recovery.
    • Embryo-Fetal Toxicity: May cause embryo-fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
    • Increased mortality in patients with multiple myeloma (MM) when venetoclax is added to bortezomib and dexamethasone. In a randomized trial in patients with relapsed or refractory MM, the addition of venetoclax to bortezomib plus dexamethasone, a use for which venetoclax is not indicated, resulted in increased mortality. Treatment of patients with MM with venetoclax in combination with bortezomib plus dexamethasone is not recommended outside of controlled clinical trials.

    Adverse Reactions

    • In CLL/SLL, the most common adverse reactions (≥20%) for venetoclax when given in combination with obinutuzumab or rituximab or as monotherapy were neutropenia, thrombocytopenia, anemia, diarrhea, nausea, upper respiratory tract infection, cough, musculoskeletal pain, fatigue, and edema.

    Review full prescribing information for additional information at www.rxabbvie.com or contact AbbVie Medical Information at 1-800-633-9110 or go to abbviemedinfo.com.

     

    BCL2-US-00070-MC
      Version 1.0 Approved May 2023

Schedule19 Apr 2024