Testing Early Treatment for Patients with High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04269902

Provider View

This study is comparing two approaches for treating high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma: starting treatment early with venetoclax and obinutuzumab, or waiting until symptoms appear. The goal is to see which approach leads to better outcomes.

Patient Parameters

Program Overview

This phase III clinical trial is exploring whether starting treatment early with the drugs venetoclax and obinutuzumab can improve outcomes for patients with high-risk chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Venetoclax works by blocking a protein that cancer cells need to survive, while obinutuzumab is an immunotherapy that helps the immune system attack cancer cells. The study will compare early treatment to delayed treatment to see which is more effective in controlling the disease.

Description

The main goal of this study is to find out if starting treatment early with venetoclax and obinutuzumab can help patients with high-risk CLL or SLL live longer compared to starting treatment later. Researchers will also look at how well the cancer responds to treatment, how long patients stay free of disease, and the safety of the treatments.

Patients will be randomly assigned to one of two groups:

  • Delayed Treatment Group: Treatment begins when specific criteria are met. Patients receive obinutuzumab through an IV and venetoclax as a pill over several cycles, with regular monitoring through scans and blood tests.
  • Early Treatment Group: Treatment starts as soon as patients are eligible. The same treatment plan as the delayed group is followed, with regular monitoring.

The study will also assess the impact of treatment on patients' quality of life and explore how certain biological markers relate to treatment outcomes. After completing the study treatment, patients will be followed for up to 10 years.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) diagnosed within the last 18 months.
  • Must have a high-risk score or complex genetic changes in the cancer cells.
  • Must have specific genetic tests completed within the last 18 months.
  • Must not have started any active treatment for CLL/SLL.
  • Must be 18 years or older.
  • Must have good overall health with a performance status of 0 to 2.
  • Must have adequate blood counts and organ function based on recent tests.
  • Must be able to take oral medications.
  • Must not have any active infections or other serious health conditions.
  • Women and men of reproductive potential must agree to use effective contraception during the study.
  • Must agree to provide blood and tissue samples for research purposes.
  • Must be able to complete quality of life assessments in one of the specified languages.
  • Must provide informed consent to participate in the study.

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