Brief Title
A Safety Study of SGN-CD33A in AML Patients
Official Title
A Phase 1 Trial of SGN-CD33A in Patients With CD33-positive Acute Myeloid Leukemia
Brief 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.
Detailed 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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Incidence of adverse events
Secondary Outcome
Blood concentrations of SGN-CD33A and metabolites
Condition
Acute Myelogenous Leukemia
Intervention
HMA
Study Arms / Comparison Groups
SGN-CD33A + HMA
Description: SGN-CD33A with hypomethylating agent
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
195
Start Date
July 2013
Completion Date
December 8, 2017
Primary Completion Date
March 18, 2016
Eligibility Criteria
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)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Phoenix Ho, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01902329
Organization ID
SGN33A-001
Responsible Party
Sponsor
Study Sponsor
Seagen Inc.
Study Sponsor
Phoenix Ho, MD, Study Director, Seagen Inc.
Verification Date
January 2018