acute myeloid leukemia MedDRA version: 9.1 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia
Conditions
Interventions
Product Name: lintuzumab
Product Code: SGN-33, HuM195
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: lintuzumab
Current Sponsor code: SGN-33, HuM195
Other descriptive
Sponsors
Seattle Genetics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet ALL of the following inclusion criteria to be eligible for inclusion into the study: 1. Must have untreated, morphologically confirmed acute myeloid leukemia as defined by the World Health Organization (WHO) Classification that occurred de novo, after prior exposure to chemotherapy for a separate malignancy, or evolved from an antecedent hematologic disorder. 2. Must be at least 60 years of age at the time of informed consent. 3. Must have at least 20% blasts in blood or marrow as documented by morphologic evaluation. 4. Must have at least 50% of leukemic blasts that express the CD33 antigen, by flow cytometric evaluation. 5. Must have an ECOG performance status score of 0 to 2. 6. Must have WBC less than 30,000/µL (pre-study use of hydroxyurea to control WBC is acceptable). 7. Females must be of non-childbearing potential, defined as those who are postmenopausal greater than 2 years or who have had a tubal ligation or hysterectomy. 8. Males must agree to use an effective contraceptive method during the course of the study. 9. Must be available for periodic blood sampling, study-related assessments and management of toxicity at the treating institution and be willing to comply with the expected drug administration schedule. 10. After being informed of the potential benefits and risks of available treatment options, patients must have declined intensive chemotherapy for AML. 11. Must give written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: If a patient is positive for ANY of the following exclusion criteria, the patient will not be eligible for inclusion into the study: 1. Must not have a known diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia. 2. Must not have any other active non-hematologic malignancies treated with chemotherapy within the last 12 months. Exception: Patients whose AML has evolved from MDS may have had prior treatment with hypomethylating agents if the agents were discontinued =2 weeks prior to patient randomization. 3. Must not have received previous chemotherapy (except hydroxyurea) for AML. 4. Must not have received any investigational agent within 4 weeks prior to randomization. 5. Must not have the following baseline laboratory evaluations: a. Aspartate transaminase (AST) greater than or equal to 2.5 times the upper limit of normal (ULN). b. Total bilirubin greater than or equal to 1.5 times ULN. c. Serum creatinine greater than or equal to 3 times ULN. 6. Must not have within 7 days of randomization either a life-threatening infection or a positive blood culture. 7. Must not have known human immunodeficiency virus (HIV). 8. Must not have a history of allergic reaction to cytarabine or any other component of drug formulation. 9. Must not be taking chronic systemic steroids exceeding 7.5 mg/day prednisone or equivalent. 10. Must not be taking any other chronic systemic immunosuppressive medication (i.e., cyclosporine, azathioprine, mycophenylate mofetil). 11. Must not have any serious underlying medical condition within 12 months prior to randomization that, in the Investigator’s opinion, would impair his/her ability to receive or tolerate the planned treatment, including but not limited to cerebrovascular accident (i.e., CVA; stroke), myocardial infarction, unstable angina, and pulmonary disease requiring supplemental oxygen. 12. Must not have evidence of dementia or altered mental status that, in the Investigator’s opinion, would preclude understanding and rendering of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether combination treatment with low dose cytarabine and lintuzumab confers a survival benefit over treatment with low dose cytarabine and placebo in patients 60 years of age and older with previously untreated AML.;Secondary Objective: Additional objectives will include: • Compare the safety and tolerability of combined therapy of low dose cytarabine and lintuzumab to low dose cytarabine alone • Determine the lintuzumab pharmacokinetic profile and immunogenicity in older patients with previously untreated AML • Assess infections that require hospitalization or IV antibiotics, transfusion requirements (platelets and red blood cell), complete blood cell counts (CBC), and quality of life in this population ;Primary end point(s): Primary: • Overall Survival Secondary: • Infections or fevers of unknown origin requiring hospitalization or intravenous (IV) antibiotics • Transfusion requirements - Platelets - Red blood cells (RBC) • Complete blood counts (CBC) - Absolute neutrophil cell (ANC) counts - Platelet counts - Hemoglobin - Peripheral blasts Additional: • Pharmacokinetic profile • Immunogenicity • Quality of Life (QOL) assessments: FACT-Leu questionnaire | — |
Countries
Austria, Bulgaria, Czech Republic, Hungary, Lithuania, Poland
Outcome results
None listed