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Long-Term Safety Study of Venetoclax for Patients with Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma, Multiple Myeloma, or Acute Leukemia

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term safety of the medication venetoclax for patients who have previously participated in a venetoclax study. The diseases being studied include Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma, Multiple Myeloma, Acute Myeloid Leukemia, and Acute Lymphocytic Leukemia. Venetoclax, also known by its code name ABT-199, is a small molecule that works by inhibiting a protein in the Bcl-2 family, which is involved in the survival of cancer cells.

The purpose of this study is to gather information on the long-term safety of venetoclax for patients who have completed a previous trial involving this medication. Participants will continue to receive venetoclax, and their health will be monitored over time to collect data on any adverse events, which are any unwanted effects that may occur during the treatment. The study will involve taking venetoclax in the form of tablets, which are either dispersible or film-coated, and are taken orally.

Throughout the study, participants will be required to follow specific procedures and guidelines, especially those with Multiple Myeloma, who will need to take preventive antibiotics to reduce the risk of infections. The study is expected to continue until early 2026, allowing researchers to collect comprehensive safety data over an extended period. Participants will not be directly addressed or encouraged to join the study, as the information provided is purely informational.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, ensure that the informed consent form is signed and dated. This form confirms understanding of the study and agreement to participate.

    Confirm that participation in a prior study involving venetoclax has been completed and that continued treatment is recommended by the investigator.

  2. Step 2

    Medication administration

    Continue taking venetoclax as a film-coated tablet, administered orally. The dosage and frequency will be determined by the study team based on individual needs.

    For those with multiple myeloma receiving venetoclax in combination with a proteasome inhibitor, take preventive antibiotics. This includes Bactrim forte® (1 tablet, 3 times a week) or an equivalent antibiotic, and Amoxicillin clavulanate (500 mg to 1 g, twice daily) or levofloxacin (500 mg once daily), adjusted for kidney function.

  3. Step 3

    Safety monitoring

    Regular monitoring for any adverse events or side effects will be conducted. Report any unusual symptoms or health changes to the study team promptly.

    The primary goal is to collect data on long-term safety while continuing treatment with venetoclax.

  4. Step 4

    Compliance with study procedures

    Adhere to all procedures and guidelines outlined in the study protocol. This includes attending scheduled appointments and following medication instructions.

    Agree to follow pregnancy avoidance measures as specified in the study protocol.

  5. Step 5

    Study duration

    The study is expected to continue until February 27, 2026. Participation will involve regular check-ins and assessments throughout this period.

    The study aims to gather comprehensive data on the long-term effects and safety of venetoclax treatment.

Who can join the trial?

5 criteria

  • The patient must have completed a previous study involving the medication venetoclax, and the doctor believes continuing this treatment is beneficial for the patient.
  • The patient must be willing or able to follow the procedures required in this study.
  • If the patient has multiple myeloma and is receiving venetoclax with a type of medication called a proteasome inhibitor, they must take preventive antibiotics during treatment and for at least 30 days after stopping the medication. This includes taking Bactrim forte® or a similar antibiotic, and Amoxicillin clavulanate or levofloxacin, or a similar antibiotic, as per the guidelines of the medical institution.
  • The patient or their legally authorized representative must voluntarily sign and date a consent form approved by an independent ethics committee or institutional review board before any study-related procedures begin.
  • The patient must agree to follow measures to avoid pregnancy as required by the study protocol.

Who cannot join the trial?

5 criteria

  • Patients with **Chronic Lymphocytic Leukemia** cannot participate.
  • Patients with **Non-Hodgkin's Lymphoma** cannot participate.
  • Patients with **Multiple Myeloma** cannot participate.
  • Patients with **Acute Myeloid Leukemia** cannot participate.
  • Patients with **Acute Lymphocytic Leukemia** cannot participate.
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Investigated drugs

Venetoclax is a medication used in this clinical trial. It is designed to help treat certain types of blood cancers by targeting and blocking a specific protein in cancer cells. This protein helps cancer cells survive, so by blocking it, venetoclax can help kill the cancer cells and slow down the progression of the disease. The trial aims to gather more information about the long-term safety of venetoclax for patients who have already participated in previous studies involving this medication.

What is already known about the treatment

Venetoclax – Venetoclax is a medication taken orally, usually in the form of a tablet, and is used to treat certain types of blood cancers, including chronic lymphocytic leukemia, non-Hodgkin's lymphoma, multiple myeloma, acute myeloid leukemia, and acute lymphocytic leukemia. It is currently being studied in clinical trials to gather long-term safety data for patients who have previously participated in venetoclax studies. The drug works by targeting and blocking a specific protein in cancer cells that helps them survive, leading to the death of these cancer cells. Venetoclax is classified as a BCL-2 inhibitor, which is a type of targeted cancer therapy.

Investigated diseases

  • Chronic Lymphocytic Leukemia

    Chronic Lymphocytic Leukemia is a type of cancer that affects the blood and bone marrow. It typically progresses slowly and is characterized by the accumulation of abnormal white blood cells called lymphocytes. These cells crowd out healthy blood cells, leading to symptoms such as fatigue, swollen lymph nodes, and frequent infections. Over time, the disease can cause anemia and bleeding problems due to the reduced number of red blood cells and platelets. The progression can vary greatly among individuals, with some experiencing a stable condition for years and others having a more aggressive form.

  • Non-Hodgkin's Lymphoma

    Non-Hodgkin's Lymphoma is a cancer that originates in the lymphatic system, which is part of the body's immune system. It involves the uncontrolled growth of lymphocytes, a type of white blood cell. The disease can start in different parts of the body, such as lymph nodes, spleen, or bone marrow, and can spread to other organs. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The progression of Non-Hodgkin's Lymphoma can vary, with some types growing slowly and others being more aggressive.

  • Multiple Myeloma

    Multiple Myeloma is a cancer of plasma cells, which are a type of white blood cell found in the bone marrow. It leads to the production of abnormal proteins that can cause damage to bones and kidneys. The disease often progresses with symptoms such as bone pain, fractures, fatigue, and frequent infections. As it advances, it can lead to anemia and high calcium levels in the blood. The progression can be slow or rapid, depending on the individual case.

  • Acute Myeloid Leukemia

    Acute Myeloid Leukemia is a fast-growing cancer of the blood and bone marrow. It is characterized by the rapid accumulation of immature white blood cells, known as myeloblasts, which interfere with the production of normal blood cells. This leads to symptoms such as fatigue, fever, easy bruising, and frequent infections. The disease progresses quickly and requires prompt medical attention. It can affect people of all ages but is more common in older adults.

  • Acute Lymphocytic Leukemia

    Acute Lymphocytic Leukemia is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature lymphocytes. It progresses rapidly and can cause symptoms such as fatigue, fever, bleeding, and frequent infections. The disease can spread to other parts of the body, including the lymph nodes, liver, and central nervous system. It is most common in children but can also occur in adults. The rapid progression requires immediate medical intervention.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501522-38-00Protocol codeM19-388Estimated enrolment165 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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