Clinical trial NCT00283114: A Safety Study of Lintuzumab in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndrome
Myeloproliferative Disorders
Chronic Myelomonocytic Leukemia
Keywords: Lintuzumab
Antigens, CD33
Antibodies, Monoclonal
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Hematologic Diseases
Myeloproliferative Disorders
Leukemia
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2006-01-27
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of adverse events and lab abnormalities.
timeFrame: 13 months
measure: Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA).
timeFrame: 13 months
measure: Antitumor activity.
timeFrame: 13 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Decatur
country: United States
facility: Cancer Care Specialists of Central Illinois
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Oncology-Hematology Consultants
state: Indiana
city: Worcester
country: United States
facility: University of Massachusetts Medical Center
state: Massachusetts
city: New York
country: United States
facility: St. Vincent's Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: Greenville
country: United States
facility: Cancer Center of the Carolinas
state: South Carolina
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
Study officials:
affiliation: Seagen Inc.
name: Eric Sievers, M.D.
role: STUDY_DIRECTOR
References:
citation: 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 Aug;50(8):1336-44. doi: 10.1080/10428190903050013.