A Phase I Study of Cusatuzumab plus Standard Therapy in People with Newly Diagnosed Acute Myeloid Leukemia

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Full Title

An Open-label, Multicenter, Phase 1b Study of JNJ-74494550 (Cusatuzumab; Anti-CD70 Monoclonal Antibody) in Combination with Background Therapy for the Treatment of Subjects with Acute Myeloid Leukemia

Purpose

The purpose of this study is to assess the safety of combining the investigational drug cusatuzumab with standard chemotherapy in patients newly diagnosed with acute myeloid leukemia (AML). Cusatuzumab works by blocking CD70, a protein on the surface of some cancer cells, thereby interrupting steps in the communication pathway that tells cancer cells to grow and divide. In this study, patients with AML will receive cusatuzumab in combination with azacitidine, or cusatuzumab in combination with azacitidine and venetoclax.

Eligibility

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

  • Patients must be newly diagnosed with AML and ineligible for intensive chemotherapy or a stem cell transplant.
  • Patients may not have received prior AML treatment.
  • 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 and to inquire about eligibility for this study, please contact Dr. Raajit Rampal at 646-608-3746.

Protocol

20-332

Phase

I

Disease Status

Newly Diagnosed

Investigator

Co-Investigators