A Phase I Study of APR-246 with Ibrutinib or with Venetoclax and Rituximab in People with Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma

Share
Print

Full Title

Phase 1 and Dose Expansion Study of APR-246 in Combination with Acalabrutinib or Venetoclax-based Therapy in Patients with Relapsed and/or Refractory Non-Hodgkin Lymphomas (NHL) Including Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL)

Purpose

The purpose of this study is to find the highest dose of the investigational drug APR-246 that can be given safely with standard therapies in patients with chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL) that has come back or continued to grow despite treatment and contains an altered form of the TP53 protein. This protein normally puts the brakes on runaway cell growth, but when it is mutated, it loses this power and cancer can result. APR-246 is designed to target mutated TP53 and may make cancer cells more sensitive to certain anticancer treatments.

In this study, there are two groups. Patients who have not previously been treated with a group of medications called BTK inhibitors, such as ibrutinib, will receive APR-246 with ibrutinib. Patients who have not previously received venetoclax will received APR-246 with venetoclax and rituximab.

Ibrutinib, venetoclax, and rituximab are standard therapies for CLL and MCL. Ibrutinib and venetoclax are taken orally (by mouth) and APR-246 and rituximab are given intravenously (by vein).

Eligibility

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

  • Patients must have CLL or MCL that has come back or continued to grow despite treatment.
  • Patients’ cancers must contain an altered form of the TP53 protein.
  • 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

20-396

Phase

I

Investigator