A Safety Study of Lintuzumab in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

Seagen Inc.82 enrolled

Overview

Phase 1a is an open-label, multi-dose, single-arm, dose-escalation study to define the toxicity profile, pharmacokinetics, and antitumor activity of SGN-33 in patients with myelodysplastic syndrome (MDS), acute myelogenous leukemia(AML), and CD33+ myeloproliferative diseases. Phase 1b includes patients with AML or MDS treated at the highest tolerated dose from phase 1a.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myeloid Leukemia Myelodysplastic Syndrome Myeloproliferative Disorders Chronic Myelomonocytic Leukemia

Interventions

lintuzumabDRUG

1.5 - 8 mg/kg IV (in the vein) on Days 1, 8, 15, 22 and 29 of Cycle 1; 1.5 - 8 mg/kg IV (in the vein) every other week for all subsequent cycles

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients must have a diagnosis of MDS or AML. 2. Patients must have an ECOG performance status ≤ 2 and a life expectancy \> 3 months. Exclusion Criteria: 1. Patients who have received prior therapy with gemtuzumab ozogamicin (Mylotarg®) or other anti-CD33 monoclonal antibody treatment. 2. Patients with a prior allogeneic transplant. 3. Patients with known leptomeningeal or CNS involvement of leukemia. Patients with onset of CNS symptoms within the past 12 months will also be excluded. 4. Patients receiving chemotherapy within the last four weeks.

Locations (9)

Rocky Mountain Cancer Center

Denver, Colorado, United States

Cancer Care Specialists of Central Illinois

Decatur, Illinois, United States

Indiana Oncology-Hematology Consultants

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

The incidence of adverse events and lab abnormalities.

Time frame: 13 months

Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA).

Time frame: 13 months

Antitumor activity.

Time frame: 13 months

Data from ClinicalTrials.gov

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