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

Seagen

Status and phase: Completed; Phase 1

Conditions: Myeloproliferative Disorders; Myelodysplastic Syndrome; Acute Myeloid Leukemia; Chronic Myelomonocytic Leukemia

Treatments: Drug: lintuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00283114

SG033-0001

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 1 patient group

1

Experimental group

Treatment:

Drug: lintuzumab