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Study of venetoclax plus rituximab in adult patients with relapsed chronic lymphocytic leukemia (CLL) in Poland

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This phase IV study focuses on adults with relapsed chronic lymphocytic leukemia (CLL) who have already received prior therapy. The investigational regimen combines an oral tablet medication, venetoclax, with an intravenous infusion drug, rituximab. The purpose of the study is to evaluate the effectiveness and safety of this combination in routine clinical practice.

Participants will take the oral medication daily, with the dose gradually increased at the start of treatment, and will receive the infusion drug on scheduled days during the first few months. Regular clinic visits will include blood tests and imaging to monitor disease status, and a special laboratory test called MRD (minimal residual disease) will be used to determine whether cancer cells are below a very low threshold. The study also examines how genetic factors such as TP53 deletion or mutation, the IGHV gene condition, and the protein marker CD38 influence outcomes; these are assessed with techniques like FISH (a test that looks at chromosomes) and NGS (a method that reads DNA sequences). Patients will complete quality‑of‑life questionnaires throughout the study, and the overall treatment experience, including any hospital stays, will be recorded.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and consent

    You attend the first study visit after being accepted into the trial and provide written consent to participate.

    The study team records your personal information, medical history of chronic lymphocytic leukemia, and any required baseline laboratory tests.

  2. Step 2

    Baseline assessments

    A series of examinations are performed to establish your health status before treatment begins.

    These may include blood tests, imaging studies, and evaluation of disease burden using flow cytometry.

  3. Step 3

    Start of rituximab infusion

    You receive rituximab by infusion at a dose of 500 mg per square meter of body surface area.

    The infusion is administered in a clinical setting according to the trial protocol.

  4. Step 4

    Start of venetoclax oral therapy

    You begin taking venetoclax tablets taken by mouth.

    The prescribed dose is 400 mg per day, using the appropriate strength tablets (10 mg, 50 mg, or 100 mg) to reach the total dose.

    The tablets are taken once daily as directed by the study medication schedule.

  5. Step 5

    Ongoing treatment and monitoring

    You continue the combined regimen of rituximab infusion and daily venetoclax tablets for the period defined by the protocol, which may extend up to 24 months.

    Regular clinic visits are scheduled to monitor response, side effects, and laboratory values.

    Blood samples are collected periodically to assess minimal residual disease (mrd) status using flow cytometry.

  6. Step 6

    Final assessment

    After the treatment period, a final evaluation is performed to determine treatment outcome, including mrd negativity and overall response.

    Quality‑of‑life questionnaires may be completed to record your experience during the study.

Who can join the trial?

25 criteria

  • Age: You must be older than 18 years.
  • Pregnancy and breastfeeding: You cannot be pregnant or nursing a baby.
  • Contraception: You must agree to use birth control as instructed, or abstain, during the study.
  • Infections: You must not have any active, serious infections at the time of enrollment.
  • Other health problems: You must not have other major medical conditions that would make the treatment unsafe, as judged by your doctor.
  • Organ function: Blood tests must show that your heart, lungs, kidneys and other organs are working well enough for treatment, according to your doctor.
  • Prior CLL/SLL treatment: You must have received earlier therapy for chronic lymphocytic leukemia or small lymphocytic lymphoma (such as chemotherapy, BTK inhibitors, venetoclax, other targeted drugs, or monoclonal antibodies). If you have taken venetoclax before, at least 36 months must have passed since the last dose.
  • Hematologic (blood) function: Your blood counts must be adequate without needing growth‑factor medicines or blood transfusions. This means hemoglobin (the protein that carries oxygen) ≥ 9 g/dL, absolute neutrophil count (a type of white blood cell) ≥ 1.0 × 10⁹/L, and platelet count (helps blood clot) ≥ 75 × 10⁹/L (lower values are allowed only if they are caused by extensive disease in the bone marrow or spleen).
  • Kidney function: Your kidneys must clear creatinine at a rate of at least 30 mL/min/1.73 m², measured by a standard calculation.
  • Liver function: Liver enzymes called AST and ALT must be no more than 2.5 times the normal upper limit, and total bilirubin must be no more than 1.5 times the normal upper limit (or up to 3 times if you have Gilbert’s syndrome, a mild inherited condition).
  • Hemolytic anemia: You must not have active destruction of red blood cells that needs treatment. A positive Coombs test (a lab test that looks for antibodies on red cells) alone does not exclude you.
  • Informed consent: You must voluntarily sign a form showing that you understand the study and agree to take part.
  • Corticosteroids: You cannot be taking steroid medicines right now, except for low‑dose steroids (less than 10 mg prednisone or equivalent) used for non‑blood‑related conditions.
  • Autoimmune complications: You must not have developed autoimmune problems (such as autoimmune hemolytic anemia or low platelets) since your CLL diagnosis that required high‑dose steroids, monoclonal antibodies, or chemotherapy.
  • Surgery: You must not have had major surgery within the 4 weeks before the first study dose, and no minor surgery within the 3 days before the first dose.
  • Radiotherapy: You must not have received radiation treatment within 4 weeks before starting the study.
  • Tumor lysis syndrome (TLS) prevention: You must be able to take medication (such as a xanthine oxidase inhibitor or rasburicase) that helps prevent TLS, a condition where cancer cells break down rapidly and can affect organ function.
  • Pregnancy testing and birth control: Women of reproductive age must have a negative pregnancy test and agree to use two reliable forms of birth control or abstain. Men must use a latex condom with women of reproductive age during the study and for at least 28 days after stopping.
  • Study compliance: You must be willing and able to follow all study visits, tests, and medication schedules.
  • Diagnosis of CLL or SLL: You must have a confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma that meets the 2018 iwCLL criteria.
  • Eligibility under the B.79 drug program: You must meet the specific criteria for receiving therapy under this national program.
  • Performance status: Your ability to carry out daily activities must be rated 0‑2 on the ECOG scale (where 0 = fully active, 2 = capable of self‑care but unable to work).
  • Indication for treatment: You must have a medical reason to start treatment according to the International Workshop on CLL (iwCLL) guidelines.
  • Contraindications: There must be no medical reasons that prevent you from safely receiving the study drug, as listed in its official product information.
  • Hypersensitivity: You must not be allergic to the study drug, any mouse‑derived proteins, or any of its ingredients.

Who cannot join the trial?

8 criteria

  • If the cancer gets worse while you are on treatment, including changing into a more aggressive type of lymphoma, you cannot take part.
  • If you have a strong allergic reaction (hypersensitivity) to any of the study drugs, to proteins that come from mice, or to any of the inactive ingredients (excipients) in the medication, you are excluded.
  • If you develop serious or life‑threatening side effects (toxicity) that cannot be controlled with normal medical care, you cannot join.
  • If you develop a rare brain infection called progressive multifocal leukoencephalopathy or severe skin reactions such as toxic epidermal necrolysis or Stevens‑Johnson syndrome while taking the study drugs, you are excluded.
  • If you have uncontrolled blood‑cell‑destroying conditions such as autoimmune hemolytic anemia (where the immune system attacks red blood cells) or immune thrombocytopenia (where the immune system destroys platelets), you cannot participate.
  • If you are pregnant or are nursing a baby (breastfeeding), you are not eligible.
  • If your doctor believes that another illness or health problem would make it unsafe for you to continue the study treatment, you are excluded.
  • If you are unable or unwilling to follow the study’s medical instructions, attend required check‑ups, or cooperate with the research team, you cannot be included.
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Investigated drugs

  • Rituximab

    is a medication given by IV infusion that targets a protein on certain white blood cells. In this study it is used as the standard treatment (comparator) to see how well the new combination works. Patients receive rituximab alone in the comparison group, and it is also part of the combination regimen being tested.

  • Venetoclax

    is an oral tablet that helps kill cancer cells by blocking a protein that keeps them alive. In this trial it is the new drug being tested (test) and is given together with rituximab. The study looks at how effective this combination is for people whose chronic lymphocytic leukemia has come back.

What is already known about the treatment

  • Rituximab

    This medication is supplied as a solution for infusion and is given by intravenous drip. It is an approved, widely used drug that appears in many clinical guidelines for blood cancers. It is mainly used to treat chronic lymphocytic leukemia, small lymphocytic lymphoma, and other B‑cell lymphomas. Rituximab works by attaching to the CD20 protein on B‑cells, which signals the immune system to destroy those cells, and it is classified as a monoclonal antibody anticancer drug.

  • Venetoclax

    Venetoclax comes as a film‑coated tablet that is taken orally. It is an approved oral therapy that has been extensively studied for blood cancers and is listed in current treatment recommendations. Its main use is for chronic lymphocytic leukemia and related disorders, often together with rituximab. The drug blocks the BCL‑2 protein inside cancer cells, allowing them to die, and it belongs to the class of targeted small‑molecule BCL‑2 inhibitors.

Investigated diseases

Chronic lymphocytic leukemia / small lymphocytic lymphoma - A cancer of the blood and bone‑marrow that produces large numbers of abnormal B‑lymphocytes. These cells accumulate slowly in the bloodstream, bone marrow, lymph nodes, and spleen. Over time the disease can expand, increasing the count of these cells and enlarging lymphoid organs. The condition often progresses gradually, but the amount of abnormal cells may rise steadily. In some patients the disease may change into a faster‑growing form.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524795-35-00Protocol code2023/ABM/01/00072Estimated enrolment36 patientsSponsorUniwersytet Medyczny W Lublinie

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