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Study on Bendamustine, Obinutuzumab, Zanubrutinib, and Venetoclax for Patients with Relapsed Chronic Lymphocytic Leukemia

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What is this study about?

This clinical trial is focused on studying a treatment for chronic lymphocytic leukemia (CLL), specifically for patients whose disease has returned or is not responding to previous treatments. The study involves a sequence of medications starting with bendamustine, followed by a combination of obinutuzumab, zanubrutinib (also known as BGB-3111), and venetoclax (also known as ABT-199). These medications are used to target and treat CLL, with the aim of evaluating their effectiveness and safety in managing the disease.

The purpose of the study is to assess how well this treatment sequence works in reducing the presence of cancer cells in the blood. Participants will first receive two cycles of bendamustine, which is an antitumor agent given through an infusion into a vein. This is followed by a combination therapy involving obinutuzumab, a protein-based drug also given by infusion, and zanubrutinib and venetoclax, which are taken orally as capsules or tablets. The study will monitor the response to these treatments over a period of time to determine their impact on the disease.

Throughout the study, participants will undergo regular assessments to track their response to the treatment. These assessments will help determine the overall response rate, which includes complete or partial responses to the therapy. The study will also monitor the safety of the treatment by recording any side effects or adverse events experienced by participants. The ultimate goal is to understand the potential benefits and risks of this treatment approach for patients with relapsed or refractory CLL.

1 initial treatment phase

The initial phase involves the administration of bendamustine hydrochloride. This medication is given through an intravenous infusion. The treatment consists of two cycles, each lasting for a specified period, to help manage chronic lymphocytic leukemia (CLL).

2 combination therapy phase

Following the initial treatment, a combination therapy is introduced. This includes obinutuzumab, administered as an intravenous infusion, zanubrutinib in capsule form, and venetoclax in film-coated tablet form. The combination aims to enhance the treatment’s effectiveness against CLL.

3 monitoring and assessment

Throughout the trial, regular monitoring is conducted to assess the response to treatment. This includes measuring the minimal residual disease (MRD) in the blood using flow cytometry. The goal is to evaluate the reduction of cancer cells and adjust the treatment plan as necessary.

4 maintenance phase

If the treatment shows a positive response, a maintenance phase may be initiated. This phase involves continued administration of the medications to sustain the treatment’s benefits and prevent relapse.

5 follow-up

After completing the treatment phases, follow-up assessments are conducted to monitor long-term outcomes. These assessments help determine the overall effectiveness of the treatment and the patient’s progression-free survival.

Who Can Join the Study?

  • The patient must have relapsed/refractory chronic lymphocytic leukemia (CLL) that needs treatment. This means the leukemia has returned or is not responding to treatment.
  • If the patient had recent treatment, they must have recovered from any immediate side effects. The previous treatment must have stopped for a certain time before starting the study:
    • At least 28 days for chemotherapy
    • At least 14 days for antibody treatment
    • At least 3 days for kinase inhibitors, BCL2-antagonists, or immuno-modulatory agents
  • Corticosteroids can be used until the study treatment starts, but must be reduced to 20mg or less of prednisolone per day during the study.
  • Patients who had disease progression during treatment with certain drugs like venetoclax or ibrutinib, or have a known resistance mutation, cannot participate. However, those who progressed after stopping these treatments or stopped due to intolerance can participate.
  • The patient must have adequate kidney function, which means their kidneys are working well enough, as shown by a creatinine clearance of 30ml/min or more.
  • The patient must have adequate blood function, meaning enough white blood cells, hemoglobin, and platelets, unless these are low due to CLL.
  • The patient must have adequate liver function, meaning their liver is working well enough, as shown by certain blood tests.
  • The patient must test negative for hepatitis B, hepatitis C, and HIV. If they have had hepatitis B in the past, they can participate if certain tests are negative and are monitored regularly.
  • The patient must be 18 years or older.
  • The patient must have an ECOG performance status of 0 to 2, which is a scale that measures how well they can perform daily activities. A score of 3 is allowed if it is due to CLL.
  • The patient must have a life expectancy of at least 6 months.
  • The patient must be able and willing to provide written informed consent and follow the study schedule and requirements.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than chronic lymphocytic leukemia that has come back or is not responding to treatment.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or take the study medications as required.
  • Patients who have other serious health conditions that might interfere with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent major surgery or are planning to have surgery during the study period.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a known allergy or severe reaction to any of the study medications.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of certain heart conditions that could be affected by the study treatment.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Saarland University Hospital Homburg Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Ubbwtivmvf Hufhjeqr Cznhybc Cologne Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
30.09.2020

Trial locations

Investigated drugs:

Bendamustine is a medication used in this trial to treat patients with chronic lymphocytic leukemia (CLL) that has returned or is resistant to previous treatments. It works by interfering with the growth of cancer cells, which are eventually destroyed.

Obinutuzumab, also known as GA101, is an antibody therapy used in this trial. It targets a specific protein on the surface of cancer cells, helping the immune system to recognize and destroy these cells.

Zanubrutinib, also referred to as BGB-3111, is a medication that blocks a protein involved in the growth and survival of cancer cells. By inhibiting this protein, zanubrutinib helps to slow down or stop the progression of the disease.

Venetoclax, also known as ABT-199, is a medication that helps to kill cancer cells by blocking a protein that prevents cell death. This allows the cancer cells to die naturally, reducing the number of cancer cells in the body.

Investigated diseases:

Chronic Lymphocytic Leukemia – Chronic lymphocytic leukemia (CLL) 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. In relapsed or refractory cases, the disease returns or does not respond to initial treatment. Over time, CLL can lead to complications like anemia and increased risk of infections. The progression of CLL varies among individuals, with some experiencing a more aggressive form of the disease.

Trial ID:
2022-502201-16-00
Protocol code:
CLL2-BZAG
NCT ID:
NCT04515238
Trial Phase:
Therapeutic exploratory (Phase II)

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