A Phase 1 Study of CSL362 (Anti-IL3Rα / Anti-CD123 Monoclonal Antibody) in Patients With CD123+ Acute Myeloid Leukemia in Complete Remission or Complete Remission With Incomplete Platelet Recovery at High Risk for Early Relapse
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Leukemia, Myeloid, Acute
Both
Leukemia, Myeloid, Acute
Trial Information
A Phase 1 Study of CSL362 (Anti-IL3Rα / Anti-CD123 Monoclonal Antibody) in Patients With CD123+ Acute Myeloid Leukemia in Complete Remission or Complete Remission With Incomplete Platelet Recovery at High Risk for Early Relapse
Inclusion Criteria:
- Male or female aged 18 years or older.
- Previous diagnosis of CD123+ acute myeloid leukemia (AML), de novo or secondary.
- Completed and recovered from all planned induction and consolidation therapy
according to the institution's standard of care, and achieved a complete remission
(CR)/CR with incomplete platelet recovery (CRp); either first or second CR.
- Has factors conferring high risk of relapse.
- No plans for additional post-remission chemotherapy.
- Not currently a candidate for allogeneic hematopoietic stem cell transplant (HSCT).
Exclusion Criteria:
- Diagnosis of acute promyelocytic leukemia (APL).
- Known leukemic involvement of the central nervous system.
- Life expectancy 4 months or less as estimated by the investigator.
- Concurrent treatment or planned treatment with other anticancer therapy
(chemotherapy, immunotherapy, radiotherapy, targeted therapy, gene therapy).
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Frequency and Severity of Adverse Events (AEs)
Outcome Description:
Number of subjects reporting any AEs and the severity of those AEs.
Outcome Time Frame:
From the first treatment (Day 1) up to approximately Day 106
Safety Issue:
Yes
Principal Investigator
Dr. Mark DeWitte
Investigator Role:
Study Director
Investigator Affiliation:
CSL Limited
Authority:
United States: Food and Drug Administration
Study ID:
CSLCT-AML-11-73
NCT ID:
NCT01632852
Start Date:
July 2012
Completion Date:
Related Keywords:
- Leukemia, Myeloid, Acute
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
|---|---|
| Seattle Cancer Care Alliance | Seattle, Washington 98109 |
| Sidney Kimmel Cancer Center At Johns Hopkins | Baltimore, Maryland 21231 |
| Weill Cornell Medical College | New York, New York 10021 |
