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

Acute Myeloid Leukemia Clinical Trial

Official title:

A Phase 1, Multi-Dose Study of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00283114
• Other study ID #: SG033-0001
• Status: Completed
• Phase: Phase 1
• First received: January 25, 2006
• Last updated: December 17, 2014
• Start date: November 2005
• Est. completion date: January 2010

Study information

• Verified date: December 2014
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Chronic Myelomonocytic Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Leukemia, Myelomonocytic, Acute
• Leukemia, Myelomonocytic, Chronic
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Myeloproliferative Disorders
• Preleukemia
• Syndrome

Intervention

Drug:
• lintuzumab
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

Locations

Country	Name	City	State
United States	Cancer Care Specialists of Central Illinois	Decatur	Illinois
United States	Rocky Mountain Cancer Center	Denver	Colorado
United States	Cancer Center of the Carolinas	Greenville	South Carolina
United States	Indiana Oncology-Hematology Consultants	Indianapolis	Indiana
United States	Memorial Sloan Kettering Cancer Center	New York	New York
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	Scott & White Memorial Hospital	Temple	Texas
United States	University of Massachusetts Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Raza A, Jurcic JG, Roboz GJ, Maris M, Stephenson JJ, Wood BL, Feldman EJ, Galili N, Grove LE, Drachman JG, Sievers EL. Complete remissions observed in acute myeloid leukemia following prolonged exposure to lintuzumab: a phase 1 trial. Leuk Lymphoma. 2009 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of adverse events and lab abnormalities.		13 months	Yes
Primary	Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA).		13 months	Yes
Primary	Antitumor activity.		13 months	No