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Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT02785900 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2018-12-12

Study results available
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Summary

The purpose of this study in AML patients is to test whether vadastuximab talirine (SGN-CD33A; 33A) combined with either azacitidine or decitabine improves remission rates and extends overall survival as compared to placebo combined with either azacitidine or decitabine.

Conditions

Interventions

DRUG

33A

33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push

DRUG

placebo

Volume equivalent to 10 mcg/kg, every 4 weeks via IV push

DRUG

azacitidine

75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks

DRUG

decitabine

20 mg/m2 given IV x 5 days, every 4 weeks

Sponsors & Collaborators

  • Seagen Inc.

    lead INDUSTRY

Principal Investigators

  • Phoenix Ho, MD · Seagen Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-10-03
Completion
2017-10-03

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Luxembourg
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02785900 on ClinicalTrials.gov