Leukemia, Myeloid, Acute Clinical Trial
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
NCT number | NCT01632852 |
Other study ID # | CSLCT-AML-11-73 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | June 29, 2012 |
Last updated | October 8, 2015 |
Start date | July 2012 |
Verified date | October 2015 |
Source | CSL Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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). |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Royal Melbourne Hospital | Parkville | Victoria |
United States | Sidney Kimmel Cancer Center at Johns Hopkins | Baltimore | Maryland |
United States | Robert H. Lurie Comprehensive Cancer Center of Northwestern University Medical School | Chicago | Illinois |
United States | Weill Cornell Medical College | New York | New York |
United States | Seattle Cancer Care Alliance | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
CSL Limited | Parexel |
United States, Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency and Severity of Adverse Events (AEs) | Number of subjects reporting any AEs and the severity of those AEs. | From the first treatment (Day 1) up to approximately Day 106 | Yes |
Primary | 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. |
From the first treatment (Day 1) up to approximately Day 106 | Yes |
Secondary | 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 (AUC0-8). The maximum observed serum concentration (Cmax). First time to reach maximum concentration in serum (Tmax). Terminal serum half-life (t 1/2) |
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 | No |
Secondary | Number of subjects developing antibodies against CSL362 | From the first treatment (Day 1) up to approximately Day 106 | No |
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