A Study of CSL362 in Patients With CD123+ Acute Myeloid Leukemia Currently in Remission
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01632852|
Recruitment Status : Completed
First Posted : July 3, 2012
Last Update Posted : October 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myeloid, Acute||Biological: CSL362||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||July 2012|
|Actual Primary Completion Date :||August 2015|
See Intervention Description
CSL362 is humanized monoclonal antibody that targets the alpha chain of the interleukin 3 receptor (IL3Rα; also known as CD123) and is optimised for enhanced activation of antibody-dependent cell-mediated cytotoxicity (ADCC) via natural killer cells.
CSL362 is a sterile solution for injection and will be administered by intravenous infusion to subjects in sequential, escalating dose level cohorts, at doses up to 12.0 mg/kg. CSL362 will be administered every 14 days for a total of 6 infusions per subject. The 6 infusions for each individual subject will contain the same dose of CSL362.
- Frequency and Severity of Adverse Events (AEs) [ Time Frame: From the first treatment (Day 1) up to approximately Day 106 ]Number of subjects reporting any AEs and the severity of those AEs.
- Dose-limiting toxicity (DLT) evaluation [ Time Frame: From the first treatment (Day 1) up to approximately Day 106 ]
Number of participants with DLT.
Dose-limiting toxicity (DLT) is defined as:
- A non-hematological toxicity grade 3 or worse.
- A hematological toxicity grade 3 that does not recover to baseline within 14 days.
- A hematological toxicity grade 4 or worse according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V4.0.
- Pharmacokinetic (PK) Parameters [ Time Frame: 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 ]
PK Parameters comprise:
Area under the serum concentration time curve (AUC) from time point zero (before dosing):
- to the time point at which the analyte first returns to baseline (AUC0-last)
- to a meaningful time after infusion (AUC0-y)
- extrapolated to infinity (AUC0-∞).
- The maximum observed serum concentration (Cmax).
- First time to reach maximum concentration in serum (Tmax).
- Terminal serum half-life (t 1/2)
- Number of subjects developing antibodies against CSL362 [ Time Frame: From the first treatment (Day 1) up to approximately Day 106 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632852
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center of Northwestern University Medical School|
|Chicago, Illinois, United States, 60611|
|United States, Maryland|
|Sidney Kimmel Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21287|
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10065|
|United States, Washington|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109|
|Royal Melbourne Hospital|
|Parkville, Victoria, Australia, 3050|
|Study Director:||Dr. Mark DeWitte||CSL Limited|