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

Phase 1

Completed

• Conditions: Acute Myeloid Leukemia; Myeloproliferative Disorders; Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia
• Interventions: Drug: lintuzumab

• Registration Number: NCT00283114
• Lead Sponsor: Seagen Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-01-25
• Study First Submitted QC: 2006-01-25
• Study First Posted: 2006-01-27
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-17
• Last Update Posted: 2014-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	lintuzumab	-

Primary Outcome Measures

Name	Time	Method
Antitumor activity.	13 months
Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA).	13 months
The incidence of adverse events and lab abnormalities.	13 months

Trial Locations

Locations (9)

Cancer Care Specialists of Central Illinois; 🇺🇸 Decatur, Illinois, United States

University of Massachusetts Medical Center; 🇺🇸 Worcester, Massachusetts, United States

Rocky Mountain Cancer Center; 🇺🇸 Denver, Colorado, United States

St. Vincent's Comprehensive Cancer Center; 🇺🇸 New York, New York, United States

Weill Medical College of Cornell University; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Cancer Center of the Carolinas; 🇺🇸 Greenville, South Carolina, United States

Indiana Oncology-Hematology Consultants; 🇺🇸 Indianapolis, Indiana, United States

Scott & White Memorial Hospital; 🇺🇸 Temple, Texas, United States