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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2015 |
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Main ID: |
NCT01632852 |
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Date of registration:
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29/06/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of CSL362 in Patients With CD123+ Acute Myeloid Leukemia Currently in Remission
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Scientific title:
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A Phase 1 Study of CSL362 (Anti-IL3Ra / 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 |
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Date of first enrolment:
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July 2012 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01632852 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Australia
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United States
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Contacts
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Name:
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Dr. Mark DeWitte |
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Address:
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Telephone:
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Email:
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Affiliation:
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CSL Limited |
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Key inclusion & exclusion criteria
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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).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Leukemia, Myeloid, Acute
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Intervention(s)
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Biological: CSL362
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Primary Outcome(s)
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Dose-limiting toxicity (DLT) evaluation
[Time Frame: From the first treatment (Day 1) up to approximately Day 106]
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Frequency and Severity of Adverse Events (AEs)
[Time Frame: From the first treatment (Day 1) up to approximately Day 106]
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Secondary Outcome(s)
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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]
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Number of subjects developing antibodies against CSL362
[Time Frame: From the first treatment (Day 1) up to approximately Day 106]
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Secondary ID(s)
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CSLCT-AML-11-73
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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