Overview

This trial is active, not recruiting.

Conditions acute myelogenous leukemia, acute myeloid leukemia, acute promyelocytic leukemia
Treatments hma, sgn-cd33a
Phase phase 1
Sponsor Seattle Genetics, Inc.
Start date July 2013
End date June 2017
Trial size 195 participants
Trial identifier NCT01902329, SGN33A-001

Summary

This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) administered as a single agent and in combination with a hypomethylating agent (HMA). The main purpose of the study is to find the maximum tolerated dose (MTD, which is the highest dose that does not cause unacceptable side effects) of SGN-CD33A in patients with acute myeloid leukemia (AML). The MTD 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-leukemia activity of SGN-CD33A will be assessed.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
SGN-CD33A with hypomethylating agent
hma
azacitidine 75 mg/m2 for 7 days or decitabine 20mg/m2 for 5 days
sgn-cd33a vadastuximab talirine
Given intravenously on Day 1 or Days 1 and 4 every 3 weeks (SGN-CD33A Monotherapy) or given intravenously on the final HMA dosing day every 4 weeks (SGN-CD33A+HMA)
(Experimental)
SGN-CD33A
sgn-cd33a vadastuximab talirine
Given intravenously on Day 1 or Days 1 and 4 every 3 weeks (SGN-CD33A Monotherapy) or given intravenously on the final HMA dosing day every 4 weeks (SGN-CD33A+HMA)

Primary Outcomes

Measure
Incidence of adverse events
time frame: Through 1 month following last dose
Incidence of laboratory abnormalities
time frame: Through 1 month following last dose

Secondary Outcomes

Measure
Blood concentrations of SGN-CD33A and metabolites
time frame: Through 3 weeks after dosing
Incidence of antitherapeutic antibodies
time frame: Through 1 month following last dose
Rate of complete remission
time frame: Up to 3 months
Duration of complete remission
time frame: Up to approximately 3 years
Relapse-free survival
time frame: Up to approximately 3 years
Overall survival
time frame: Up to approximately 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Acute myeloid leukemia, positive for CD33 - Eastern Cooperative Oncology Group status of 0 or 1 - Adequate baseline renal and hepatic function - Central venous access - Either achieved complete remission (greater than 12 weeks in duration) with initial induction/consolidation and have experienced relapse of disease or declined treatment with high-dose induction/consolidation - Bone marrow blasts greater than or equal to 5% for relapsed patients, or greater than or equal to 20% for untreated patients Exclusion Criteria: - Inadequate lung function - Prior allogeneic stem cell transplant, except for a specific cohort - High-dose chemotherapy within 4 weeks of study drug - Antileukemia treatment within 14 days of study drug (other than hydroxyurea or 6-mercaptopurine)

Additional Information

Official title A Phase 1 Trial of SGN-CD33A in Patients With CD33-positive Acute Myeloid Leukemia
Description This study will explore SGN-CD33A as a monotherapy and in combination with a hypomethylating agent (HMA; i.e., azacitidine or decitabine). Initial study treatment with SGN-CD33A includes a maximum of 2 cycles of treatment for monotherapy and 4 cycles for combination cohorts. Patients who achieve documented CR or CRi (Monotherapy) or clinical benefit (Combination) during the first part of the study are eligible to continue treatment. Additional monotherapy cohorts may include patients with relapsed acute promyelocytic leukemia, relapsed patients with nucleophosmin-1 gene mutation (absence of fms-like tyrosine kinase 3 mutation) (NPM1-mutated, FLT-3 wild type), alternate dosing schedules (fractionated dosing on Days 1 and 4), treatment naive patients with AML who declined intensive therapy, and patients who have relapsed after post-allogeneic stem cell transplant. Patients in the combination cohort will be treated with azacitidine or decitabine per institutional practice prior to SGN-CD33A dosing. Expansion cohorts may be added for further evaluation of safety, pharmacokinetics, pharmacodynamics, and antitumor activity.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Seattle Genetics, Inc..
Location data was received from the National Cancer Institute and was last updated in August 2016.