A Study of Lintuzumab (SGN-33) in Combination With Low Dose Cytarabine in Patients 60+ Years With AML

Seagen Inc.211 enrolled

Overview

The purpose of this study is to assess whether there is a survival benefit with lintuzumab given in combination with low dose cytarabine versus low dose cytarabine and placebo in patients with AML.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

211

Conditions

Acute Myeloid Leukemia

Interventions

Lintuzumab (SGN-33)DRUG

600 mg IV on days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles.

Low dose cytarabineDRUG

20 mg SC twice a day on days 1-10 of each 28 day cycle up to a maximum of 12 cycles.

PlaceboDRUG

IV administration on days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Untreated AML that occurred de novo, after prior exposure to chemotherapy for a separate malignancy, or evolved from an antecedent hematologic disorder. * After being informed of the potential benefits and risks of available treatment options, patients must have declined intensive chemotherapy for AML. * At least 20% blasts in blood or marrow. * Must have a minimum of 50% leukemic blasts that express CD33. * ECOG performance status score of 0 to 2. * WBC less than 30,000/µL Exclusion Criteria: * No known diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia. * No other active systemic malignancies treated with chemotherapy within the last 12 months. * Must not have received previous chemotherapy (except hydroxyurea) for AML. * Must not have significantly abnormal kidney or liver disease. * Must not have known human immunodeficiency virus (HIV).

Locations (20)

Southern Cancer Center

Mobile, Alabama, United States

Outcomes

Primary Outcomes

Overall survival

Time frame: 12 months

Secondary Outcomes

Complete blood counts (CBC), Transfusion Requirements, Infections or Fevers of Unknown Origin Requiring Hospitalization or IV Antibiotics

Time frame: 13 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.