A Phase II Study of CLT-008 Treatment as Supportive Care During Initial Chemotherapy for Acute Myeloid Leukemia in Older Adults

Full Title

An Open-Label Phase 2 Prospective, Randomized, Controlled Study of CLT-008 Myeloid Progenitor Cells as a Supportive Care Measure During Induction Chemotherapy for Acute Myeloid Leukemia

Purpose

The chemotherapy drugs used during initial ("induction") chemotherapy for acute myeloid leukemia (AML) cause the numbers of a patient's white blood cells to decrease significantly, putting patients at risk of infection. G-CSF is a drug used to boost white blood cell counts during chemotherapy. In this study, researchers want to see if adding an investigational treatment called CLT-008 can further elevate white blood cell counts, reducing a patient's risk of infection.

CLT-008 is a product made from blood-forming stem cells from healthy donors. It is designed to produce a variety of blood cells. Patients in this study will be randomly assigned to receive G-CSF alone (given by injection) or with CLT-008 (given by vein) during induction chemotherapy.

Eligibility

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

  • Patients must be scheduled to receive induction therapy for AML.
  • Patients may not have had prior chemotherapy for AML.
  • 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 55 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Martin Tallman at 212-639-3842.

Protocol

16-1033

Phase

II

Investigator

Locations