A Safety Study of SGN-CD33A in AML Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Seattle Genetics, Inc.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01902329
First received: July 15, 2013
Last updated: January 28, 2016
Last verified: January 2016

July 15, 2013
January 28, 2016
July 2013
June 2017   (final data collection date for primary outcome measure)
  • Incidence of adverse events [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01902329 on ClinicalTrials.gov Archive Site
  • Blood concentrations of SGN-CD33A and metabolites [ Time Frame: Through 3 weeks after dosing ] [ Designated as safety issue: No ]
  • Incidence of antitherapeutic antibodies [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Rate of complete remission [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
  • Duration of complete remission [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Relapse-free survival [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Safety Study of SGN-CD33A in AML Patients
A Phase 1 Trial of SGN-CD33A in Patients With CD33-positive Acute Myeloid Leukemia
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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Myelogenous Leukemia
  • Acute Myeloid Leukemia
  • Acute Promyelocytic Leukemia
  • Drug: HMA
    azacitidine 75 mg/m2 for 7 days or decitabine 20mg/m2 for 5 days
  • Drug: SGN-CD33A
    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)
    Other Name: vadastuximab talirine
  • Experimental: SGN-CD33A + HMA
    SGN-CD33A with hypomethylating agent
    Interventions:
    • Drug: HMA
    • Drug: SGN-CD33A
  • Experimental: SGN-CD33A Monotherapy
    SGN-CD33A
    Intervention: Drug: SGN-CD33A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
225
December 2017
June 2017   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com
United States
 
NCT01902329
SGN33A-001
No
Not Provided
Not Provided
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Not Provided
Study Director: Phoenix Ho, MD Seattle Genetics, Inc.
Seattle Genetics, Inc.
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP