A Phase I/II Study of Low-Dose Cytarabine and Lintuzumab-Ac-225 in Older Patients with Previously Untreated Acute Myeloid Leukemia

Protocol
09-053
Full Title
A Phase I/II Study of Low Dose Cytarabine and Lintuzumab-AC-225 in Older Patients with Untreated Acute Myeloid Leukemia
Phase
I/II
Disease Status
Newly Diagnosed
Purpose

The standard treatment for acute myeloid leukemia (AML) can cause side effects that are difficult for older patients to tolerate. The purpose of this study is to find the highest safe dose of an investigational drug called lintuzumab-Ac-225 that can be given safely with low-dose cytarabine in patients with untreated AML who are age 60 or older, and to evaluate their effectiveness together.

Lintuzumab is a monoclonal antibody that targets a protein on AML cells called CD33. Ac-225 is a radioactive substance. The lintuzumab is designed to ferry the Ac-225 directly to AML cells, where the radiation can kill them. Cytarabine is a standard chemotherapy drug used to treat AML, but the dose being used in this study is lower than usual, to reduce the risk of side effects in older individuals.

In the first part of this study, investigators will determine the optimal dose of lintuzumab-Ac-225 to give with low-dose cytarabine. In the second part, they will examine the effectiveness of this drug combination for treating AML.

Eligibility

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

  • Patients must have previously untreated AML with at least a 20 percent blast count.
  • Patients must be at least age 60. Those who are age 60-69 must decline or be unable to receive treatment with standard chemotherapy.
  • All patients must have at least 25 percent of their blasts expressing the CD33 protein.
  • This study is open to patients who are capable of only limited self-care and are confined to a bed or chair for more than half of their waking hours, as well as those who are in better physical condition.

For more information about this study and to inquire about eligibility, please contact Dr. Jae Park at 212-639-4048.

Disease(s)
Leukemia
Leukemia: Acute Myelocytic Leukemia
Leukemia: Acute Myelogenous Leukemia
Locations

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