Study on Bendamustine/Rituximab Followed by Venetoclax and Rituximab for Treating Chronic Lymphocytic Leukemia

Sponsor: Nicole Lamanna

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03609593

Provider View

This clinical trial is testing a treatment plan for Chronic Lymphocytic Leukemia (CLL) using a combination of drugs: bendamustine, rituximab, and venetoclax. The study aims to see if this combination can effectively treat CLL over a 15-month period.

Patient Parameters

Program Overview

The study is designed to test the effectiveness of a treatment plan for Chronic Lymphocytic Leukemia (CLL) using bendamustine and rituximab, followed by venetoclax for 12 months. The total treatment time is 15 months. Bendamustine and rituximab are commonly used for CLL, while venetoclax is an oral medication that targets a protein called BCL-2 on CLL cells. This study aims to see if this combination can help manage CLL, especially in patients whose cancer has returned or did not respond to previous treatments.

Description

This clinical trial involves a treatment plan for Chronic Lymphocytic Leukemia (CLL) using a combination of drugs: bendamustine, rituximab, and venetoclax. The study will last for 15 months, with patients receiving bendamustine and rituximab first, followed by venetoclax. Venetoclax is gradually increased to a daily dose of 400 mg over five weeks. Once this dose is reached, patients will also receive rituximab for six months. The study will monitor patients' responses at various points to assess the effectiveness of the treatment. Special tests will be conducted to check for any remaining cancer cells. Patients will also receive preventive treatments to avoid infections and a condition called tumor lysis syndrome, which can occur when cancer cells break down rapidly.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Diagnosed with Chronic Lymphocytic Leukemia (CLL).
  • Have a high number of lymphocytes in the blood or bone marrow.
  • No previous treatment for CLL, except for certain corticosteroids for other conditions.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • May have autoimmune conditions affecting blood cells, with approval from the study leader.
  • Have adequate blood cell counts and liver function.
  • Must understand and agree to the study requirements, including signing a consent form.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study.
  • Men and women must agree to use birth control during the study and for a period after.

Exclusion Criteria

  • Previously treated for CLL or small lymphocytic lymphoma, except with corticosteroids for symptoms.
  • Recent use of certain medications or substances that affect the study drugs.
  • Known allergies to specific medications used in the study.
  • Significant medical conditions that could interfere with the study.
  • Active infections or certain viral infections that require treatment.
  • Positive for HIV.
  • Heart conditions that require treatment.
  • Pregnant or breastfeeding women.
  • History of other active cancers within the past two years, with some exceptions.
  • Conditions that affect the absorption of oral medications.
  • History of Richter's syndrome.
  • Currently being treated for non-blood-related autoimmune diseases.
  • Previous stem cell transplant.
  • Allergic reactions to similar drugs used in the study.
  • Consumption of grapefruit, Seville oranges, or star fruit within three days before starting the study.

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