Study on Venetoclax and Obinutuzumab for Adults with Recurring Chronic Lymphocytic Leukemia

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for Chronic Lymphocytic Leukemia (CLL), a type of cancer that affects the blood and bone marrow. The treatment being tested involves a combination of two medications: Venetoclax and Obinutuzumab. Venetoclax, also known by its code name ABT-199, is a small molecule that targets a specific protein in cancer cells, while Obinutuzumab is a type of medication called an antibody, which helps the immune system to attack cancer cells.

The purpose of this study is to evaluate how effective and safe this combination treatment is for patients whose CLL has returned after previous treatment. Participants in the study will receive Venetoclax in the form of a film-coated tablet taken orally, and Obinutuzumab as a solution for infusion, which means it is given directly into a vein. The study will follow participants over a period of time to monitor changes in their disease and any side effects they may experience.

Throughout the study, participants will be assessed to see how their disease responds to the treatment. The study aims to understand the overall response rate, which is the proportion of participants who show improvement in their condition. Other aspects being evaluated include how long it takes for the treatment to start working, how long the response lasts, and the time until any further treatment is needed. The study will also look at progression-free survival, which is the length of time during and after treatment that a patient lives with the disease without it getting worse, and overall survival, which is the length of time a patient lives after starting the treatment.

1 initiation of treatment

The treatment begins with the administration of obinutuzumab through an intravenous infusion. This is a solution that is delivered directly into the bloodstream.

The infusion is given in a healthcare setting under the supervision of medical professionals.

2 oral medication phase

Following the initial infusion, venetoclax is introduced. This medication is taken orally in the form of film-coated tablets.

The dosage of venetoclax is gradually increased over a period of time to reach the target dose. This process is known as dose ramp-up and is designed to minimize side effects.

3 combination treatment

The treatment continues with a combination of oral venetoclax and intravenous obinutuzumab.

This phase aims to maximize the effectiveness of the treatment by using both medications together.

4 monitoring and assessment

Throughout the treatment, regular assessments are conducted to monitor the response to the medications.

These assessments include blood tests and other evaluations to determine the overall response rate, which is the proportion of patients achieving a significant reduction in disease activity.

5 end of treatment evaluation

At the end of the treatment cycle, a comprehensive evaluation is performed to assess the overall response and any changes in disease activity.

The primary goal is to determine the effectiveness of the treatment in achieving a complete or partial response.

6 follow-up period

After the treatment cycle is completed, a follow-up period is initiated to monitor the duration of the response and any potential progression of the disease.

This period includes regular check-ups and assessments to ensure ongoing health and well-being.

Who Can Join the Study?

  • You must sign a form agreeing to participate in the study. This form is approved by an independent committee to ensure your rights are protected.
  • You must not be in prison and must be able to give your consent freely. This means you should not be under legal protection or unable to express your consent.
  • You need to have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) that requires retreatment. CLL is a type of cancer that affects the blood and bone marrow.
  • You should have previously completed a treatment with venetoclax and an anti-CD20 antibody as your first treatment and shown a positive response. This means your disease improved with the treatment.
  • You should not be receiving any approved second-line therapies, based on your and your doctor’s decision.
  • If you are in Cohort 1, more than 24 months should have passed since your last dose of venetoclax before needing treatment again. If you are in Cohort 2, it should be between 12 to 24 months.
  • You should not have received any other treatment for CLL after completing your previous treatment with venetoclax and anti-CD20 antibody.
  • You should not have stopped your previous venetoclax treatment because your disease got worse during the treatment.
  • You should not have active or uncontrolled autoimmune hemolytic anemia or immune thrombocytopenic purpura. These are conditions where your immune system attacks your own blood cells.
  • Your CLL should not have changed into a more aggressive form of cancer, like Richter’s transformation or pro-lymphocytic leukemia.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria
Rostock University Medical Center Rostock Germany
Gemeinschaftspraxis Haematologie Onkologie Dresden Germany

Other Sites

Site Name City Country Status
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Hristo Botev AD Vratsa Bulgaria
Dr. Vehling-Kaiser MVZ GmbH Landshut Germany
Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbH Paderborn Germany
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Saarland University Hospital Homburg Germany
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse Vienna Austria
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Azienda Ospedaliera S Maria Di Terni Terni Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Deutsches Herzzentrum Berlin Berlin Germany
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts Mutlangen Germany
Onkologische Schwerpunktpraxis Kurfuerstendamm Berlin Germany
Fundeni Clinical Institute Bucharest Romania
Kaehrjcy Lzxiwtbm Abmxe Dva Szonu Lezqjhfp Landshut Germany
Sgmmelulcizzchzo Kziycyaaulsbmigl Ghhiclruga Leoben Austria
Uctvigqkwp Hvohulqs Cboyczf Cologne Germany
Asccssx Ojnexxquvcb Udwyjeajwulwt Cefxvtqtwsgi Dmawi Snmiyz E Dumjg Stnbwjw Dw Tproyo Turin Italy
Usiwtyptmopifhlfkdlvg Ewukh Aoe Essen Germany
Ovjjvgvpbcwayl Lbly Gtlc Linz Austria
Mdblzspohtdaybnwgaqzftuzdr Hjcjwrcxmvelqzdi Halle (Saale) Germany
Hesecgbu Utwwktlxksajy Dd Lm Puwrhtbt Madrid Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
28.03.2022
Bulgaria Bulgaria
Recruiting
28.03.2022
Germany Germany
Recruiting
28.03.2022
Italy Italy
Recruiting
28.03.2022
Romania Romania
Recruiting
28.03.2022
Spain Spain
Recruiting
28.03.2022

Trial locations

Investigated drugs:

Venetoclax is a medication used in this trial to treat patients with recurring chronic lymphocytic leukemia. It works by helping to kill cancer cells and is often used in combination with other treatments to improve its effectiveness.

Obinutuzumab is another medication involved in the trial. It is an antibody therapy that targets specific proteins on cancer cells, helping the immune system to recognize and destroy these cells. It is used alongside Venetoclax to enhance the treatment’s overall impact on the leukemia.

Chronic Lymphocytic Leukemia Recurrent – This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of abnormal white blood cells called lymphocytes. In its recurrent form, the disease returns after a period of improvement or remission. It typically progresses slowly, with symptoms that may include swollen lymph nodes, fatigue, fever, and weight loss. Over time, the abnormal lymphocytes can crowd out healthy blood cells, leading to complications such as anemia and increased risk of infections. The disease’s progression can vary greatly among individuals, with some experiencing rapid changes while others have a more indolent course.

Trial ID:
2023-504599-10-00
Protocol code:
M20-356
NCT ID:
NCT04895436
Trial Phase:
Therapeutic exploratory (Phase II)

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