Back to resultsA Study of CSL362 in Patients With CD123+ Acute Myeloid Leukemia Currently in Remission
Primary Purpose
Leukemia, Myeloid, Acute
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CSL362
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Myeloid, Acute
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).
Sites / Locations
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University Medical School
- Sidney Kimmel Cancer Center at Johns Hopkins
- Weill Cornell Medical College
- Seattle Cancer Care Alliance
- Royal Melbourne Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CSL362
Arm Description
See Intervention Description
Outcomes
Primary Outcome Measures
Frequency and Severity of Adverse Events (AEs)
Number of subjects reporting any AEs and the severity of those AEs.
Dose-limiting toxicity (DLT) evaluation
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.
Secondary Outcome Measures
Pharmacokinetic (PK) Parameters
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
Full Information
NCT ID
NCT01632852
First Posted
June 29, 2012
Last Updated
October 8, 2015
Sponsor
CSL Limited
Collaborators
Parexel
1. Study Identification
Unique Protocol Identification Number
NCT01632852
Brief Title
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
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Limited
Collaborators
Parexel
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CSL362
Arm Type
Experimental
Arm Description
See Intervention Description
Intervention Type
Biological
Intervention Name(s)
CSL362
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.
Primary Outcome Measure Information:
Title
Frequency and Severity of Adverse Events (AEs)
Description
Number of subjects reporting any AEs and the severity of those AEs.
Time Frame
From the first treatment (Day 1) up to approximately Day 106
Title
Dose-limiting toxicity (DLT) evaluation
Description
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.
Time Frame
From the first treatment (Day 1) up to approximately Day 106
Secondary Outcome Measure Information:
Title
Pharmacokinetic (PK) Parameters
Description
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)
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
Title
Number of subjects developing antibodies against CSL362
Time Frame
From the first treatment (Day 1) up to approximately Day 106
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Mark DeWitte
Organizational Affiliation
CSL Limited
Official's Role
Study Director
Facility Information:
Facility Name
Robert H. Lurie Comprehensive Cancer Center of Northwestern University Medical School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Sidney Kimmel Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
A Study of CSL362 in Patients With CD123+ Acute Myeloid Leukemia Currently in Remission
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