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Study on the Safety and Effectiveness of Venetoclax, Atezolizumab, and Obinutuzumab for Patients with Richter Syndrome from Chronic Lymphocytic Leukemia

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What is this study about?

This clinical trial is focused on studying a condition known as Richter syndrome, which is a transformation of chronic lymphocytic leukemia (CLL) into a more aggressive form of lymphoma. The trial is testing a combination of three treatments: venetoclax, atezolizumab, and obinutuzumab. Venetoclax is a medication that comes in the form of a film-coated tablet and is taken orally. Atezolizumab and obinutuzumab are both monoclonal antibodies, which are proteins designed to target specific cells, and are administered through an intravenous infusion, meaning they are given directly into a vein.

The purpose of this study is to evaluate the safety and effectiveness of this combination of treatments in patients with Richter syndrome. Participants in the study will receive these medications over a period of time, and their response to the treatment will be monitored. The study aims to see if the combination can achieve a significant response rate, which means a reduction in the size or extent of the cancer. The study will also look at how long the response lasts, the time it takes for the disease to progress, and the overall survival of the participants.

Throughout the study, the occurrence of any side effects or serious adverse events will be closely monitored. This includes any significant changes in laboratory test results and how well participants tolerate the doses of the medications. The study will provide valuable information on the potential benefits and risks of using venetoclax, atezolizumab, and obinutuzumab together for treating Richter syndrome in CLL patients.

1 initial treatment phase

Begin taking venetoclax tablets orally. The dosage will be gradually increased over a period of several weeks to reach the target dose. This process is known as dose escalation and is designed to minimize side effects.

Receive obinutuzumab through an intravenous infusion. This is a solution administered directly into the bloodstream. The infusion schedule will be provided by the healthcare team.

2 combination treatment phase

Continue taking venetoclax tablets orally at the target dose as determined in the initial treatment phase.

Receive atezolizumab through an intravenous infusion. This medication is also administered directly into the bloodstream. The infusion schedule will be provided by the healthcare team.

Continue receiving obinutuzumab infusions as scheduled.

3 evaluation phase

Undergo regular assessments to evaluate the response to the treatment. This includes imaging tests and blood tests to monitor the condition and the effectiveness of the treatment.

The primary goal is to achieve a minimum of 67% overall response rate (ORR) by the end of the sixth cycle of treatment. This will be evaluated using specific criteria for aggressive lymphomas.

4 monitoring phase

Continue to be monitored for any adverse events or side effects. This includes regular check-ups and laboratory tests to ensure safety and tolerability of the treatment.

The healthcare team will assess the complete remission rate, duration of response, progression-free survival, and overall survival as part of the secondary objectives of the trial.

Who Can Join the Study?

  • Ability to understand and willingness to sign a written informed consent document.
  • For women who can have children: Agree to avoid pregnancy by either not having heterosexual intercourse or using a very effective birth control method during the treatment and for a specific time after the last dose of the study drugs. This time varies depending on the drug: at least 30 days after venetoclax, 5 months after atezolizumab, or 18 months after obinutuzumab, whichever is longer.
  • Signed informed consent.
  • Confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma with a biopsy showing transformation to diffuse large B cell lymphoma, which is consistent with Richter’s Syndrome.
  • Age 18 years or older.
  • ECOG performance status of 2 or less. This is a scale used to assess how a disease affects a patient’s daily living abilities, with lower numbers indicating better function.
  • Meet certain blood health criteria at screening, unless there is significant bone marrow involvement:
    • Absolute neutrophil count of at least 1000 cells/mm3.
    • Platelet count of at least 50,000 cells/mm3 within 7 days of screening.
    • Total hemoglobin greater than 9 g/dL without needing a blood transfusion, unless anemia is due to bone marrow involvement of the leukemia.
  • Have adequate blood clotting, kidney, and liver function based on lab tests at screening:
    • Activated partial thromboplastin time (aPTT) and International normalized ratio (INR) should be less than or equal to 1.5 times the upper limit of normal for those not on blood thinners.
    • Creatinine should be less than or equal to 1.5 times the upper limit of normal, or creatinine clearance should be at least 50 mL/min.
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) should be less than or equal to 2.5 times the upper limit of normal.
    • Bilirubin should be less than or equal to 1.5 times the upper limit of normal, but can be up to 3 times the upper limit if the patient has Gilbert’s Syndrome or resolving autoimmune hemolytic anemia.
  • Negative pregnancy test results confirmed by the investigator before starting any treatment.

Who Cannot Join the Study?

  • Patients with other types of cancer that are not related to Richter syndrome of chronic lymphocytic leukemia cannot participate. Richter syndrome is a condition where a type of blood cancer called chronic lymphocytic leukemia changes into a more aggressive form.
  • Patients who have had a different cancer treatment recently may not be eligible.
  • Patients with severe or uncontrolled medical conditions that could interfere with the study may be excluded.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have allergies to the study medications or their ingredients cannot participate.
  • Patients with certain infections that are not well controlled may be excluded.
  • Patients who are unable to follow the study procedures or attend the required visits may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Universita Degli Studi Di Brescia Brescia Italy
Awuyytq Ofojqvtmwbh Upcfsvqeemueg Cwqnqdkuolve Dkdbs Sqmtte E Djwbn Slasbgz De Ticquq Turin Italy
Aeyrqgk Ogfgvqsissn Npoquhgzw Sx Arhjlwk E Bnccua E C Ayrtpo Amtgifavvet Alexandria Italy
Avtaaft Uetxh Scrkaoblk Litqln Du Bsotajo Bologna Italy
Aonmpbl Odqfgnvumto Prgu Gtmlfgjg Xqyss Bergamo Italy

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Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
08.10.2019

Trial locations

Investigated drugs:

Venetoclax is a medication used to help treat certain types of blood cancers. It works by targeting and blocking a specific protein that cancer cells need to survive, which can help to kill the cancer cells and slow down the progression of the disease.

Atezolizumab is an immunotherapy drug that helps the body’s immune system to recognize and attack cancer cells. It works by blocking a protein that prevents the immune system from attacking the cancer, thereby boosting the body’s natural defenses against the tumor.

Obinutuzumab is a type of antibody therapy that targets specific proteins on the surface of cancer cells. It helps the immune system to identify and destroy these cancer cells, and is often used in combination with other cancer treatments to improve their effectiveness.

Investigated diseases:

Richter Syndrome of Chronic Lymphocytic Leukemia – This is a condition where chronic lymphocytic leukemia (CLL), a type of blood cancer, transforms into a more aggressive form of lymphoma. It typically involves a sudden change in the behavior of the leukemia cells, leading to rapid growth and spread. Patients may experience symptoms such as enlarged lymph nodes, fever, night sweats, and weight loss. The disease progression is marked by the aggressive nature of the transformed lymphoma, which can affect various parts of the body. This transformation can occur at any stage of CLL and often requires different management strategies compared to the original leukemia. The condition is named after Dr. Maurice Richter, who first described it.

Trial ID:
2024-516675-32-00
Protocol code:
MOLTO
Trial Phase:
Therapeutic exploratory (Phase II)

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