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

• Sponsor: Seagen Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02848248
• Collaborator: (none)
• Enrollment: 17
• Locations: 7
• Arm: 1
• Actual Duration (Months): 20.1
• Patients Per Site: 2.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: SGN-CD123A	Phase 1

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Study of SGN-CD123A in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
• Actual Study Start Date: Aug 1, 2016
• Actual Primary Completion Date: Apr 6, 2018
• Actual Study Completion Date: Apr 6, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SGN-CD123A SGN-CD123A every 3 weeks	Drug: SGN-CD123A; Intravenous infusion in 3-week cycles

Outcome Measures

Primary Outcome Measures

1. Type, incidence, severity, seriousness, and relatedness of adverse events [Through 1 month following last dose, or end-of-treatment visit whichever is later]

2. Type, incidence, and severity of laboratory abnormalities [Through 1 month following last dose, or end-of-treatment visit whichever is later]

3. Incidence of dose-limiting toxicity [First cycle of treatment, 3 weeks]

Secondary Outcome Measures

1. Blood concentrations of SGN-CD123A, total antibodies, and metabolites [Through 1 month following last dose, or end-of-treatment visit whichever is later]

2. Incidence of antitherapeutic antibodies [Through 1 month following last dose, or end-of-treatment visit whichever is later]

3. Rate of remission [Through 1 month following last dose, or end-of-treatment visit whichever is later]

4. Duration of complete remission [Up to approximately 1 year]

5. Leukemia-free survival [Up to approximately 1 year]

6. Overall survival [Up to approximately 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	City of Hope National Medical Center	Duarte	California	United States	91010-3000
3	University of Colorado Hospital / University of Colorado	Aurora	Colorado	United States	80045-0510
4	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
5	Hudson Valley Hematology and Oncology Associates/New York Medical College	Hawthorne	New York	United States	10532-2168
6	MD Anderson Cancer Center / University of Texas	Houston	Texas	United States	77030-4095
7	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109-1024

Sponsors and Collaborators

• Seagen Inc.

Investigators

• Study Director: Phoenix Ho, MD, Seagen Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seagen Inc.
• ClinicalTrials.gov Identifier: NCT02848248
• Other Study ID Numbers: SGN123-001
• First Posted: Jul 28, 2016
• Last Update Posted: May 14, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Seagen Inc.: Acute Myeloid Leukemia; Antibody-Drug Conjugate; CD123 Antigen; Drug Therapy; AML; Leukemia, Myeloid, Acute
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute

Study Results

No Results Posted as of May 14, 2018