Lintuzumab-Ac225 in Older Acute Myeloid Leukemia (AML) Patients

Completed · Phase 1/Phase 2

Conditions studied: AML

In brief

The study is a multicenter, open label Phase I/II trial. 1. Establish the MTD of fractionated doses of Lintuzumab-Ac225 in combination with low dose cytosine arabinoside (Low Dose Ara-C, LDAC) (Phase 1 portion) 2. Determine the response rate (CR + CRp + CRi) to fractionated doses of Lintuzumab-Ac225 alone (Phase 2 portion)

Key facts

Study ID

NCT02575963

Run by

Actinium Pharmaceuticals

People needed

40

Starts

2012-10-01

Expected to finish

2020-05-01

Last updated by the study team

2023-07-20

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients with acute promyelocytic leukemia
• Treatment with chemotherapy or biologic therapy within 3 weeks, except for hydroxyurea, which must be discontinued prior to treatment on study
• Treatment with radiation within 6 weeks
• Active serious infections uncontrolled by antibiotics
• Active malignancy within 2 years of entry, except previously treated non-melanoma skin cancer, carcinoma in situ or cervical intraepithelial neoplasia, and organ confined prostate cancer with no evidence of progressive disease based on PSA levels and are not on active therapy.
• Clinically significant cardiac or pulmonary disease
• Patients with liver cirrhosis
• Active CNS leukemia. Patients with symptoms of CNS involvement, particularly those with M4 or M5 subtypes, should undergo lumbar puncture prior to treatment on study to exclude CNS disease. Symptoms include cranial neuropathies, other neurologic deficits, and headache.
• Psychiatric disorder that would preclude study participation

Where it is running

• UCLA Medical Center, Division of Hematology/Oncology — Los Angeles, California, United States
• University of Kentucky, Markey Cancer Center — Lexington, Kentucky, United States
• University of Louisville, James Graham Brown Cancer Center — Louisville, Kentucky, United States
• Ochsner Medical Center, The Gayle and Tom Benson Cancer Center — New Orleans, Louisiana, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Weill Medical College of Cornell University — New York, New York, United States
• Columbia University Medical, Herbert Irving Comprehensive Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke Cancer Center — Durham, North Carolina, United States
• University of Pennsylvania, Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States
• St. Francis Cancer Center — Greenville, South Carolina, United States
• Baylor Scott and White Research Institute, Charles A. Sammons Cancer Center — Dallas, Texas, United States
• Swedish Cancer Institute, Center for Blood Disorders and Stem Cell Transplantation — Seattle, Washington, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
• West Virginia University, Mary Babb Randolph Cancer Center — Morgantown, West Virginia, United States
• Medical College of Wisconsin Cancer Center — Milwaukee, Wisconsin, United States
• VA Caribbean Healthcare System — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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