Acute Myeloid Leukemia, Myelodysplastic Syndrome, Myeloproliferative Disorders, Chronic Myelomonocytic Leukemia
Conditions
Keywords
Lintuzumab, Antigens, CD33, Antibodies, Monoclonal, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Hematologic Diseases, Myeloproliferative Disorders, Leukemia
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.
Interventions
DRUGlintuzumab
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
Sponsors
Seagen Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events and lab abnormalities. | 13 months |
| Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA). | 13 months |
| Antitumor activity. | 13 months |
Countries
United States
Outcome results
None listed