A Phase II Study Assessing Limited Treatment Time with Acalabrutinib Combined with Obinutuzumab in People Newly Diagnosed with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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Full Title

A Phase 2 Time Limited Approach Based on Depth of Response to Front-Line Acalabrutinib in Combination with Obinutuzumab for CLL/SLL Patients Who Achieve Complete Remission or Partial Remission with Undetectable Minimal Residual Disease

Purpose

The usual approach to treating chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) is continuous treatment with acalabrutinib and obinutuzumab, even if the cancer is no longer detectable, until the cancer either gets worse or comes back. However, people who receive these drugs for long periods of time can develop resistance to this treatment, and the drugs no longer work as well as they did initially to fight the cancer.

Researchers are doing this study to learn whether stopping treatment when the cancer responds to the drugs, followed by a period of observation (without treatment), is better than, the same as, or worse than the usual approach. Stopping treatment when there is no minimal residual disease (MRD, or small numbers of cancer cells remaining in the bone marrow), followed by observation and monitoring for MRD, may be a safe alternative to the usual approach because it can reduce the frequency and severity of side effects, and it may reduce the risk of the cancer becoming resistant to treatment. Acalabrutinib is taken orally (by mouth) and obinutuzumab is given intravenously (by vein).

An important part of treating CLL and SLL includes regular monitoring with tests for MRD. In this study, researchers will monitor MRD with a test that looks for cancer cells in a blood sample rather than in the bone marrow. This approach makes the test easier for patients.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have previously untreated CLL or SLL.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Anthony Mato at 646-608-3748.

Protocol

20-503

Phase

II

Investigator

Co-Investigators