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

May 8, 2018 updated by: Seagen Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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)

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope National Medical Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Colorado Blood Cancer Institute
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Cardinal Bernardin Cancer Center / Loyola University Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute / Wayne State University
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic, The
      • Columbus, Ohio, United States, 43210
        • James Cancer Hospital / Ohio State University
    • Tennessee
      • Nashville, Tennessee, United States, 30384
        • Sarah Cannon Research Institute
    • Texas
      • Dallas, Texas, United States, 75246
        • Charles A. Sammons Cancer Center / Baylor University Medical Center
      • Houston, Texas, United States, 77030-4095
        • MD Anderson Cancer Center / University of Texas
    • Washington
      • Seattle, Washington, United States, 98109-1024
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Induction with SGN-CD33A
7+3 (Standard dose cytarabine for induction and daunorubicin) + SGN-CD33A
Drug: Standard dose cytarabine for induction
100 mg/m2/day Days 1-7
Drug: SGN-CD33A
Given intravenously Day 1 or Days 1 and 4 of each cycle
Other Names:
  • vadastuximab talirine
Drug: Daunorubicin
60 mg/m2/day Days 1-3
Experimental: Consolidation with SGN-CD33A
High dose cytarabine for consolidation + SGN-CD33A (28-day cycles)
Drug: SGN-CD33A
Given intravenously Day 1 or Days 1 and 4 of each cycle
Other Names:
  • vadastuximab talirine
Drug: High dose cytarabine for consolidation
3g/m2 on Days 1, 3, and 5 of each cycle
Experimental: SGN-CD33A Maintenance
SGN-CD33A Monotherapy (42-day cycles)
Drug: SGN-CD33A
Given intravenously Day 1 or Days 1 and 4 of each cycle
Other Names:
  • vadastuximab talirine
Experimental: Induction and Consolidation with SGN-CD33A
7+3 (standard dose cytarabine for induction and daunorubicin) + SGN-CD33A and High dose cytarabine for consolidation + SGN-CD33A
Drug: Standard dose cytarabine for induction
100 mg/m2/day Days 1-7
Drug: SGN-CD33A
Given intravenously Day 1 or Days 1 and 4 of each cycle
Other Names:
  • vadastuximab talirine
Drug: Daunorubicin
60 mg/m2/day Days 1-3
Drug: High dose cytarabine for consolidation
3g/m2 on Days 1, 3, and 5 of each cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: Through 1 month following last dose
Through 1 month following last dose
Incidence of laboratory abnormalities
Time Frame: Through 1 month following last dose
Through 1 month following last dose
Incidence of dose-limiting toxicity (DLT)
Time Frame: Through 1 month following last dose
Through 1 month following last dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Complete remission (CR) rate at the end of induction
Time Frame: Through 1 month following last dose
Through 1 month following last dose
Leukemia-free survival
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Blood concentrations of SGN-CD33A and metabolites
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Incidence of antitherapeutic antibodies (ATA)
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Rate of minimal residual disease (MRD) clearance
Time Frame: Up to approximately 3 years
Up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Investigators

  • Study Director: Eric Feldman, MD, Seagen Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

January 30, 2017

Study Completion (Actual)

April 10, 2018

Study Registration Dates

First Submitted

December 18, 2014

First Submitted That Met QC Criteria

December 22, 2014

First Posted (Estimate)

December 29, 2014

Study Record Updates

Last Update Posted (Actual)

May 9, 2018

Last Update Submitted That Met QC Criteria

May 8, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGN33A-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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