Clinical trial NCT01632852: A Study of CSL362 in Patients With CD123+ Acute Myeloid Leukemia Currently in Remission
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leukemia, Myeloid, Acute
Lead sponsor: CSL Limited
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2012-07-03
Enrollment: 30
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: This is a first in human, prospective, multicenter, nonrandomized, open-label, dose-escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of repeat doses of CSL362.


Eligibility criteria: 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).

Primary outcomes:
measure: Frequency and Severity of Adverse Events (AEs)
timeFrame: From the first treatment (Day 1) up to approximately Day 106
measure: Dose-limiting toxicity (DLT) evaluation
timeFrame: From the first treatment (Day 1) up to approximately Day 106
Secondary outcomes:
measure: Pharmacokinetic (PK) Parameters
timeFrame: Before each infusion and: at 6 time points within a week after infusion 1, at 1 time point within a week after infusions 2 to 5, at 5 time points within a week after infusion 6, and once at the final visit, approximately 5 weeks after infusion 6
measure: Number of subjects developing antibodies against CSL362
timeFrame: From the first treatment (Day 1) up to approximately Day 106
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University Medical School
state: Illinois
city: Baltimore
country: United States
facility: Sidney Kimmel Cancer Center at Johns Hopkins
state: Maryland
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: CSL Limited
name: Dr. Mark DeWitte
role: STUDY_DIRECTOR
References: