NCT02326584

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

Study Contact:

Study Phase:

PHASE1

Recruitment Status:

COMPLETED

NCT ID:

NCT02326584

Principal Investigator:

Study Type:

INTERVENTIONAL

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

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.

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

Disease(s) and\or Condition(s)

Acute Myeloid Leukemia

Acute Myelogenous Leukemia

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: Standard dose cytarabine for induction
- Description: 100 mg/m2/day Days 1-7
- Arm Group Labels: Induction and Consolidation with SGN-CD33A, Induction with SGN-CD33A
- Type: DRUG
- Name: SGN-CD33A
- Description: Given intravenously Day 1 or Days 1 and 4 of each cycle
- Arm Group Labels: Consolidation with SGN-CD33A, Induction and Consolidation with SGN-CD33A, Induction with SGN-CD33A, SGN-CD33A Maintenance
- Type: DRUG
- Name: Daunorubicin
- Description: 60 mg/m2/day Days 1-3
- Arm Group Labels: Induction and Consolidation with SGN-CD33A, Induction with SGN-CD33A
- Type: DRUG
- Name: High dose cytarabine for consolidation
- Description: 3g/m2 on Days 1, 3, and 5 of each cycle
- Arm Group Labels: Consolidation with SGN-CD33A, Induction and Consolidation with SGN-CD33A

Sponsor

Seagen Inc.