Acute Myeloid Leukemia
Conditions
Keywords
Acute Myeloid Leukemia, Antibody-Drug Conjugate, CD123 Antigen, Drug Therapy, AML, Leukemia, Myeloid, Acute
Brief summary
The study will examine the safety profile of SGN-CD123A. The study will test increasing doses of SGN-CD123A given every 3 weeks to patients.
Detailed description
This study is designed to evaluate the safety, tolerability, and preliminary estimate of antitumor activity of SGN-CD123A. The study will be conducted in 2 parts: 1. Part A is the dose-escalation portion of the trial, designed to identify the maximum tolerated dose (MTD) of SGN-CD123A 2. Part B is the dose-expansion portion of the trial, designed to evaluate SGN-CD123A in patients with differing CD123 expression levels Dose-escalation in Part A will be conducted using a 3+3 study design. Patients with CD123-detectable AML will be enrolled in cohorts at escalating doses of study drug and will receive up to 2 induction cycles of SGN-CD123A treatment at an assigned dose level in 3-week cycles. After completion of dose-escalation, patients will be enrolled in Part B of the study. Patients enrolled in Part B will receive up to 2 induction cycles of SGN-CD123A treatment at a dose level and frequency determined by results in Part A. For both Part A and Part B, a third induction cycle may be permitted with the approval of the study medical monitor. If a patient achieves a complete remission or complete remission with incomplete hematologic recovery, optional post-remission cycles of SGN-CD123A may be administered.
Interventions
DRUGSGN-CD123A
Intravenous infusion in 3-week 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 74 Years
Healthy volunteers
No
Inclusion criteria
* Relapsed/refractory acute myeloid leukemia following at least 2 but no more than 3 prior regimens * Patients may be eligible after only 1 previous regimen if in a high risk category * Adequate baseline renal and hepatic function * Eastern Cooperative Oncology Group Status of 0 or 1 * CD123-detectable leukemia
Exclusion criteria
* Cerebral/meningeal disease related to underlying malignancy * Promyelocytic leukemia * History of clinically significant pulmonary fibrosis or documented diffusing capacity of the lung for carbon monoxide \<50% predicted * Prior hematopoietic stem cell transplant * Antileukemia or experimental treatment within 4 weeks of study drug (other than hydroxyurea or 6-mercaptopurine) * Cardio or cerebral vascular event within 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type, incidence, severity, seriousness, and relatedness of adverse events | Through 1 month following last dose, or end-of-treatment visit whichever is later |
| Type, incidence, and severity of laboratory abnormalities | Through 1 month following last dose, or end-of-treatment visit whichever is later |
| Incidence of dose-limiting toxicity | First cycle of treatment, 3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Duration of complete remission | Up to approximately 1 year |
| Blood concentrations of SGN-CD123A, total antibodies, and metabolites | Through 1 month following last dose, or end-of-treatment visit whichever is later |
| Overall survival | Up to approximately 1 year |
| Leukemia-free survival | Up to approximately 1 year |
| Incidence of antitherapeutic antibodies | Through 1 month following last dose, or end-of-treatment visit whichever is later |
| Rate of remission | Through 1 month following last dose, or end-of-treatment visit whichever is later |
Countries
United States
Outcome results
None listed