Acute Myeloid Leukemia Clinical Trial

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A Study of CSL362 in Patients With CD123+ Acute Myeloid Leukemia Currently in Remission

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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.

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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).

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT01632852

Recruitment Status:

Completed

Sponsor:

CSL Limited

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There are 5 Locations for this study

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Robert H. Lurie Comprehensive Cancer Center of Northwestern University Medical School
Chicago Illinois, 60611, United States
Sidney Kimmel Cancer Center at Johns Hopkins
Baltimore Maryland, 21287, United States
Weill Cornell Medical College
New York New York, 10065, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Royal Melbourne Hospital
Parkville Victoria, 3050, Australia
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How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT01632852

Recruitment Status:

Completed

Sponsor:


CSL Limited

How clear is this clinincal trial information?

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