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NCT Number: NCT02326584

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Acute Myelogenous Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard dose cytarabine for induction

Drug

100 mg/m2/day Days 1-7

SGN-CD33A

Drug

Given intravenously Day 1 or Days 1 and 4 of each cycle

Other names: vadastuximab talirine

Daunorubicin

Drug

60 mg/m2/day Days 1-3

High dose cytarabine for consolidation

Drug

3g/m2 on Days 1, 3, and 5 of each cycle

Primary outcomes

  1. Incidence of adverse events

    Time frame: Through 1 month following last dose

  2. Incidence of laboratory abnormalities

    Time frame: Through 1 month following last dose

  3. Incidence of dose-limiting toxicity (DLT)

    Time frame: Through 1 month following last dose

Secondary outcomes

  1. Complete remission (CR) rate at the end of induction

    Time frame: Through 1 month following last dose

  2. Leukemia-free survival

    Time frame: Up to approximately 3 years

  3. Overall survival

    Time frame: Up to approximately 3 years

  4. Blood concentrations of SGN-CD33A and metabolites

    Time frame: Up to approximately 3 years

  5. Incidence of antitherapeutic antibodies (ATA)

    Time frame: Up to approximately 3 years

  6. Rate of minimal residual disease (MRD) clearance

    Time frame: Up to approximately 3 years

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Dec 29, 2014
Registry last updated
May 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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