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Low Dose Cytarabine and Lintuzumab-Ac225 in Older Patients
Complete title: A Phase I/II Study of Low Dose Cytarabine and Lintuzumab-Ac225 in Older Patients with Untreated Acute Myeloid Leukemia
|Research Study Number||2572.00|
|Principal Investigator||John Pagel, MD, PhD|
Research Study Description
The goal of the Phase 2 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.
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- 1. Untreated acute myelogenous leukemia (AML), including patients with an antecedent hematologic disorder or secondary disease. Patients with prior myelodysplastic syndromes (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 ahve no measurable disease are not undergoing active therapy, and have a life expectancy of greater than or equal 4 months.
- 2. Patients age greater than or equal to 60 years who: a. Are unwilling to receive intensive (e.g. 7+3) chemotherapy, or b. Have poor-risk prognostic factors defined as antecedent hematologic disorder, prior chemotherapy or chemoradiation therapy (XRT), abnormal karyotype other than t(8;21), inv16, or t(16;16), any karyotype with Internal tandem duplications of Flt3 (Flt3-ITD), or presenting white blood count (WBC) greater than 100K, or c. 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 d. Any patient age greater than or equal to 70 years.
- 3. Blast count greater than or equal to 20 percent (World Health Organization (WHO) criteria)
- 4. Greater than 25 percent of blasts must be CD33 positive.
- 5. Creatinine less than 2.0 mg/dl
- 6. Estimated creatinine clearance greater than or equal to 50ml/min.
- 7. Bilirubin less than or equal to 2.0 mg/dl; aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) less than or equal to 2.5 times the upper limits of normal (ULN).
- 8. Eastern Cooperative Oncology Group (ECOG) Performance status less than or equal to 3.
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 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 prostate-specific antigen (PSA) levels and are not on active therapy
- 6. Clinically significant cardiac or pulmonary disease
- 7. Active central nervous system (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
Other exclusion criteria may apply.
Acute Myeloid Leukemia (AML); Hematologic Malignancies
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