A Phase I/II Study of Low Dose Cytarabine and Lintuzumab-Ac225 in Older Patients With Untreated Acute Myeloid Leukemia

The study is a multicenter, open label Phase I/II trial.

The goal of the Phase I part of this study is to find the highest tolerable dose of Lintuzumab-Ac225 that can be given with cytarabine to patients with AML.

The goal of the Phase II part of this study is to learn if Lintuzumab-Ac225 and cytarabine can control AML. The safety of this drug combination will also be studied.

Lintuzumab-Ac225 is designed to deliver radiation therapy directly inside leukemia cells without giving any radiation to the surrounding normal cells

Cytarabine is designed to insert itself into DNA (genetic material) of cancer cells and stop the DNA from repairing itself.

Cancer (Oncology), Cancer (Oncology) - Leukemia
John Pagel, MD, PhD
Swedish Cancer Institute
Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Untreated AML, including patients with an antecedent hematologic disorder or secondary disease. Patients with prior MDS may have received therapy with immunomodulatory agents or hypomethylating agents for this diagnosis. Patients with other prior cancer diagnoses are allowed as long as they have no measurable disease are not undergoing active therapy, and have a life expectancy of ≥ 4 months.
  2. Patients age ≥60 years who:

    1. Are unwilling to receive intensive (e.g. 7+3) chemotherapy, or
    2. Have poor-risk prognostic factors defined as antecedent hematologic disorder, prior chemotherapy or XRT, abnormal karyotype other than t(8;21), inv16, or t(16;16), any karyotype with FLT3-ITD, or presenting WBC>100K, or
    3. Have significant comorbidities, that in the judgment of the investigator makes the subject unsuitable for standard dose induction chemotherapy (e.g. anthracycline and infusional cytarabine given as 7+3), or;
    4. Any patient age ≥ 70 years.
  3. Blast count ≥20%
  4. Greater than 25% of blasts must be CD33 positive.
  5. Adequate renal and hepatic function
  6. ECOG ≤ 3

Exclusion Criteria:

  1. Patients with acute promyelocytic leukemia
  2. Treatment with chemotherapy or biologic therapy within 3 weeks, except for hydroxyurea, which must be discontinued prior to treatment on study
  3. Treatment with radiation within 6 weeks
  4. Active serious infections uncontrolled by antibiotics
  5. 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.
  6. Clinically significant cardiac or pulmonary disease
  7. 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.
  8. Psychiatric disorder that would preclude study participation
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