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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Leukemia, Myeloid, Acute

Thank you

Trial Information

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


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).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and Severity of Adverse Events (AEs)

Outcome Description:

Number of subjects reporting any AEs and the severity of those AEs.

Outcome Time Frame:

From the first treatment (Day 1) up to approximately Day 106

Safety Issue:

Yes

Principal Investigator

Dr. Mark DeWitte

Investigator Role:

Study Director

Investigator Affiliation:

CSL Limited

Authority:

United States: Food and Drug Administration

Study ID:

CSLCT-AML-11-73

NCT ID:

NCT01632852

Start Date:

July 2012

Completion Date:

Related Keywords:

  • Leukemia, Myeloid, Acute
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Seattle Cancer Care AllianceSeattle, Washington  98109
Sidney Kimmel Cancer Center At Johns HopkinsBaltimore, Maryland  21231
Weill Cornell Medical CollegeNew York, New York  10021