A Safety Study of SGN-CD123A in Patients With Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

Official title:

A Phase 1 Study of SGN-CD123A in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02848248
• Other study ID #: SGN123-001
• Status: Terminated
• Phase: Phase 1
• Start date: August 2016
• Est. completion date: April 6, 2018

Study information

• Verified date: May 2018
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will examine the safety profile of SGN-CD123A. The study will test increasing doses of SGN-CD123A given every 3 weeks to patients.

Description:

This study is designed to evaluate the safety, tolerability, and preliminary estimate of antitumor activity of SGN-CD123A. The study will be conducted in 2 parts:

1. Part A is the dose-escalation portion of the trial, designed to identify the maximum tolerated dose (MTD) of SGN-CD123A

2. Part B is the dose-expansion portion of the trial, designed to evaluate SGN-CD123A in patients with differing CD123 expression levels

Dose-escalation in Part A will be conducted using a 3+3 study design. Patients with CD123-detectable AML will be enrolled in cohorts at escalating doses of study drug and will receive up to 2 induction cycles of SGN-CD123A treatment at an assigned dose level in 3-week cycles.

After completion of dose-escalation, patients will be enrolled in Part B of the study. Patients enrolled in Part B will receive up to 2 induction cycles of SGN-CD123A treatment at a dose level and frequency determined by results in Part A.

For both Part A and Part B, a third induction cycle may be permitted with the approval of the study medical monitor. If a patient achieves a complete remission or complete remission with incomplete hematologic recovery, optional post-remission cycles of SGN-CD123A may be administered.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: April 6, 2018
• Est. primary completion date: April 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• Relapsed/refractory acute myeloid leukemia following at least 2 but no more than 3 prior regimens

• Patients may be eligible after only 1 previous regimen if in a high risk category

• Adequate baseline renal and hepatic function

• Eastern Cooperative Oncology Group Status of 0 or 1

• CD123-detectable leukemia

Exclusion Criteria:

• Cerebral/meningeal disease related to underlying malignancy

• Promyelocytic leukemia

• History of clinically significant pulmonary fibrosis or documented diffusing capacity of the lung for carbon monoxide <50% predicted

• Prior hematopoietic stem cell transplant

• Antileukemia or experimental treatment within 4 weeks of study drug (other than hydroxyurea or 6-mercaptopurine)

• Cardio or cerebral vascular event within 6 months

Related Conditions & MeSH terms

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

Intervention

Drug:
• SGN-CD123A
Intravenous infusion in 3-week cycles

Locations

Country	Name	City	State
United States	University of Colorado Hospital / University of Colorado	Aurora	Colorado
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	City of Hope National Medical Center	Duarte	California
United States	Hudson Valley Hematology and Oncology Associates/New York Medical College	Hawthorne	New York
United States	MD Anderson Cancer Center / University of Texas	Houston	Texas
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type, incidence, severity, seriousness, and relatedness of adverse events		Through 1 month following last dose, or end-of-treatment visit whichever is later
Primary	Type, incidence, and severity of laboratory abnormalities		Through 1 month following last dose, or end-of-treatment visit whichever is later
Primary	Incidence of dose-limiting toxicity		First cycle of treatment, 3 weeks
Secondary	Blood concentrations of SGN-CD123A, total antibodies, and metabolites		Through 1 month following last dose, or end-of-treatment visit whichever is later
Secondary	Incidence of antitherapeutic antibodies		Through 1 month following last dose, or end-of-treatment visit whichever is later
Secondary	Rate of remission		Through 1 month following last dose, or end-of-treatment visit whichever is later
Secondary	Duration of complete remission		Up to approximately 1 year
Secondary	Leukemia-free survival		Up to approximately 1 year
Secondary	Overall survival		Up to approximately 1 year