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

Seagen

Status and phase: Completed; Phase 1

Conditions: Acute Myelogenous Leukemia; Acute Myeloid Leukemia

Treatments: Drug: SGN-CD33A; Drug: High dose cytarabine for consolidation; Drug: Standard dose cytarabine for induction; Drug: Daunorubicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02326584

SGN33A-002

Details and patient eligibility

About

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.

Full 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)

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 4 patient groups

Induction with SGN-CD33A

Experimental group

Description:

7+3 (Standard dose cytarabine for induction and daunorubicin) + SGN-CD33A

Treatment:

Drug: Standard dose cytarabine for induction

Drug: Daunorubicin

Drug: SGN-CD33A

Consolidation with SGN-CD33A

Experimental group

Description:

High dose cytarabine for consolidation + SGN-CD33A (28-day cycles)

Treatment:

Drug: High dose cytarabine for consolidation

Drug: SGN-CD33A

SGN-CD33A Maintenance

Experimental group

Description:

SGN-CD33A Monotherapy (42-day cycles)

Treatment:

Drug: SGN-CD33A

Induction and Consolidation with SGN-CD33A

Experimental group

Description:

7+3 (standard dose cytarabine for induction and daunorubicin) + SGN-CD33A and High dose cytarabine for consolidation + SGN-CD33A

Treatment:

Drug: Standard dose cytarabine for induction

Drug: High dose cytarabine for consolidation

Drug: Daunorubicin

Drug: SGN-CD33A