Study on Acalabrutinib, Venetoclax, and Durvalumab for Treating Richter Transformation from Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05388006

Provider View

This clinical trial is testing a combination of three drugs—acalabrutinib, venetoclax, and durvalumab—to see if they can help treat Richter transformation, a condition where chronic lymphocytic leukemia or small lymphocytic lymphoma turns into a more aggressive type of lymphoma.

Patient Parameters

Program Overview

This study aims to find out if a combination of three drugs—acalabrutinib, venetoclax, and durvalumab—can effectively treat patients with Richter transformation, a rare condition where chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) changes into a fast-growing type of lymphoma. Acalabrutinib and venetoclax work by blocking proteins that cancer cells need to grow, while durvalumab is an immunotherapy that helps the immune system attack cancer cells. The study hopes to improve survival rates for patients with this condition.

Description

The main goal of this study is to see if the combination of acalabrutinib, venetoclax, and durvalumab can help patients with Richter transformation from chronic lymphocytic leukemia (CLL) live longer without the disease getting worse. Researchers will also look at how safe the treatment is and how well it works in shrinking the cancer.

Patients in the study will take acalabrutinib by mouth twice a day, receive durvalumab through an IV once a month, and take venetoclax by mouth once a day. This treatment cycle will repeat every 28 days for up to 12 cycles, as long as the cancer does not progress and the side effects are manageable.

After the initial treatment, patients will continue with acalabrutinib and venetoclax for maintenance therapy, repeating every 90 days for up to 4 cycles, again depending on the cancer's response and side effects.

Participants will be monitored closely, with follow-up visits 30 days after completing the treatment and then every 90 days for up to 5 years to track their health and the treatment's effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and willing to provide consent and follow-up.
  • Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) based on specific medical criteria.
  • Have a confirmed diagnosis of Richter transformation from CLL.
  • Have measurable disease that can be detected by scans.
  • Be in good overall health with an ECOG performance status of 0, 1, or 2.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 0.7 x 10^9/L, or 0.3 x 10^9/L if bone marrow is involved.
    • Platelet count of at least 40 x 10^9/L, or 30 x 10^9/L if bone marrow is involved.
    • Hemoglobin level of at least 8, or 7 if bone marrow is involved.
    • Normal liver and kidney function as indicated by specific blood tests.
  • Women of childbearing potential must agree to use effective contraception during and for 180 days after treatment.
  • Men must agree to use condoms and spermicide during and for 180 days after treatment.
  • Willing to provide tissue, blood, and bone marrow samples for research purposes.

Exclusion Criteria

  • Have uncontrolled heart conditions, such as recent heart attack or severe heart disease.
  • Have serious gastrointestinal conditions causing diarrhea.
  • Have a history of certain brain conditions, like stroke or bleeding in the brain, within the past 6 months.
  • Have active, uncontrolled infections or tuberculosis.
  • Have HIV, hepatitis B, or hepatitis C infections that are not well-controlled.
  • Be pregnant or breastfeeding.
  • Be unwilling to use effective contraception if of childbearing potential.
  • Have received other investigational treatments recently.
  • Have active autoimmune or inflammatory disorders that are not well-controlled.
  • Have significant lung disease or psychiatric conditions that would interfere with the study.
  • Have active central nervous system lymphoma.
  • Have had a stem cell transplant within the past 2 years or have active graft versus host disease.
  • Be taking certain medications that cannot be stopped or switched.
  • Have a history of another primary cancer unless it was treated and is not active.
  • Have received a live vaccine recently.
  • Have had major surgery recently.
  • Weigh less than 30 kg.
  • Have a life expectancy of less than 12 weeks.

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