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

NCT02326584 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2018-05-09

No results posted yet for this study

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.

Conditions

Interventions

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

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

Sponsors & Collaborators

  • Seagen Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Feldman, MD · Seagen Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-01-30
Completion
2018-04-10

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT02326584 on ClinicalTrials.gov