Study on Acalabrutinib With or Without Obinutuzumab for Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03516617

Provider View

This clinical trial is exploring whether the drug acalabrutinib, alone or combined with obinutuzumab, is effective in treating patients with early-stage chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study aims to see if these treatments can stop cancer cell growth and help the immune system fight the cancer.

Patient Parameters

Program Overview

The purpose of this study is to find out if acalabrutinib, with or without the addition of obinutuzumab, can effectively treat patients with early-stage chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Acalabrutinib works by blocking certain enzymes that cancer cells need to grow, while obinutuzumab is an immunotherapy that helps the immune system attack cancer cells. Researchers want to see if these treatments can stop the cancer from growing and spreading.

Description

The study is divided into different parts based on the risk level of the patients' cancer, as determined by a specific scoring system called the CLL-International Prognostic Index (CLL-IPI).

Primary Goals:

  • Compare how well acalabrutinib alone and acalabrutinib with obinutuzumab work in eliminating cancer cells in the bone marrow of high-risk patients.
  • Measure the time it takes for low and intermediate-risk patients to need their first treatment.

Secondary Goals:

  • Compare the safety of the two treatment options in high-risk patients.
  • Evaluate overall response rates, how long patients live without the cancer getting worse, and overall survival rates.
  • Assess quality of life using a specific survey.

Research Goals:

  • Study changes in immune cells in the blood and bone marrow.
  • Analyze specific proteins and genes related to cancer growth and treatment resistance.

Study Groups:

  • Arm A: High-risk patients receive acalabrutinib twice daily for 6 cycles, then continue if needed.
  • Arm B: High-risk patients receive acalabrutinib and obinutuzumab for 6 cycles, then continue acalabrutinib if needed.
  • Arm C: Low and intermediate-risk patients are monitored every 6 months for up to 2 years.

After treatment, all patients will have follow-up visits every 6 months for up to 10 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Diagnosed with either small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL).
  • Must not have received any prior treatment for CLL or SLL.
  • Must undergo testing for risk factors according to the CLL-IPI.
  • Must have a performance status score of 0, 1, or 2, indicating good overall health.
  • Must agree to provide blood and saliva samples for research.
  • Must be willing to return for follow-up visits.
  • For high-risk patients: Must meet specific blood count and organ function criteria.
  • Must have a negative pregnancy test if of childbearing potential.
  • Must provide a bone marrow sample for research purposes.

Exclusion Criteria

  • Diagnosed with CLL/SLL more than 24 months ago.
  • Previously treated with certain cancer drugs like ibrutinib or BCL-2 inhibitors.
  • Have central nervous system lymphoma or leukemia.
  • Have certain symptoms or conditions that require chemotherapy.
  • Have severe health issues that could interfere with the study.
  • HIV positive and on antiretroviral therapy.
  • Have uncontrolled illnesses or psychiatric conditions.
  • Participating in another clinical trial for the same condition.
  • Have had another active cancer within the last 2 years, with some exceptions.
  • Have had a heart attack or severe heart issues within the last 6 months.
  • For high-risk patients: Must not be pregnant or breastfeeding, and must not have active hepatitis B or C.
  • Must not have had a stroke or severe bleeding issues recently.
  • Must not require certain medications that interfere with the study drugs.
  • Must not have had a recent gastrointestinal ulcer or certain infections.

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