A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML

Acute Myeloid Leukemia Clinical Trial

Official title:

A Phase 1b Dose-escalation Study of SGN-CD33A in Combination With Standard-of-care for Patients With Newly Diagnosed Acute Myeloid Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02326584
• Other study ID #: SGN33A-002
• Status: Completed
• Phase: Phase 1
• Start date: December 2014
• Est. completion date: April 10, 2018

Study information

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

Clinical Trial Summary

This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) by itself (monotherapy) or in combination with other standard treatments. The main purpose of this study is to find the best dose and schedule for SGN-CD33A when given in combination with standard induction treatment, in combination with standard consolidation treatment, or by itself for maintenance treatment. This will be determined by observing the dose-limiting toxicities (the side effects that prevent further increases in dose) of SGN-CD33A. In addition, the pharmacokinetic profile and anti-leukemic activity of the study treatment will be assessed.

Description:

The study will be conducted in the following distinct parts:

Part A: Induction dose escalation - 7+3 combined with SGN-CD33A (Day 1 and Day 4 dosing)

Part B: Consolidation dose escalation - consolidation combined with SGN-CD33A; up to 4 cycles of consolidation therapy will be administered after SGN-CD33A (Day 1 of each cycle).

Part C: Maintenance - SGN-CD33A Monotherapy; Up to 24 patients with and up to 24 patient without prior allogeneic stem cell transplant will be treated with SGN-CD33A. Both arms will enroll simultaneously. SGN-CD33A will be administered on Day 1 of each 6-week cycle for up to 8 cycles.

Part D: Induction plus consolidation - induction/consolidation combined with SGN-CD33A; patients who achieve a CR/CRi (with or without a second induction) will receive up to 4 cycles of consolidation therapy administered after SGN-CD33A (Day 1 of each cycle).

Part E: Induction dose escalation - 7+3 combined with SGN-CD33A (Day 1 dosing)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: April 10, 2018
• Est. primary completion date: January 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All subtypes of Acute Myeloid leukemia (except for acute promyelocytic leukemia)

• Eastern Cooperative Oncology Group status of 0 or 1

• Adequate baseline renal and hepatic function

• Central venous access

• Part specific requirements: eligible to receive induction; achieved CR/CRi with standard induction and eligible to receive consolidation; in CR with documented blood count recovery for maintenance

Exclusion Criteria:

• Previous treatment for MDS or MPN for dose escalation cohorts

• Inadequate lung function

• Inadequate heart function

Related Conditions & MeSH terms

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

Intervention

Drug:
• Standard dose cytarabine for induction
100 mg/m2/day Days 1-7
• SGN-CD33A
Given intravenously Day 1 or Days 1 and 4 of each cycle
• Daunorubicin
60 mg/m2/day Days 1-3
• High dose cytarabine for consolidation
3g/m2 on Days 1, 3, and 5 of each cycle

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cleveland Clinic, The	Cleveland	Ohio
United States	James Cancer Hospital / Ohio State University	Columbus	Ohio
United States	Charles A. Sammons Cancer Center / Baylor University Medical Center	Dallas	Texas
United States	Colorado Blood Cancer Institute	Denver	Colorado
United States	Karmanos Cancer Institute / Wayne State University	Detroit	Michigan
United States	City of Hope National Medical Center	Duarte	California
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	MD Anderson Cancer Center / University of Texas	Houston	Texas
United States	Cardinal Bernardin Cancer Center / Loyola University Medical Center	Maywood	Illinois
United States	Sarah Cannon Research Institute	Nashville	Tennessee
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	Incidence of adverse events		Through 1 month following last dose
Primary	Incidence of laboratory abnormalities		Through 1 month following last dose
Primary	Incidence of dose-limiting toxicity (DLT)		Through 1 month following last dose
Secondary	Complete remission (CR) rate at the end of induction		Through 1 month following last dose
Secondary	Leukemia-free survival		Up to approximately 3 years
Secondary	Overall survival		Up to approximately 3 years
Secondary	Blood concentrations of SGN-CD33A and metabolites		Up to approximately 3 years
Secondary	Incidence of antitherapeutic antibodies (ATA)		Up to approximately 3 years
Secondary	Rate of minimal residual disease (MRD) clearance		Up to approximately 3 years