A Safety Study of SGN-CD33A in AML Patients

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01902329
Study type	Interventional
Source	Seattle Genetics, Inc.
Contact
Status	Completed
Phase	Phase 1
Start date	July 2013
Completion date	December 8, 2017

View Details

See also
Status	Clinical Trial	Phase
Suspended	`NCT05400122` - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer	Phase 1
Recruiting	`NCT04460235` - Immunogenicity of an Anti-pneumococcal Combined Vaccination in Acute Leukemia or Lymphoma	Phase 4
Active, not recruiting	`NCT03678493` - A Study of FMT in Patients With AML Allo HSCT in Recipients	Phase 2
Completed	`NCT04022785` - PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome	Phase 1
Recruiting	`NCT05424562` - A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Canada
Completed	`NCT03197714` - Clinical Trial of OPB-111077 in Patients With Relapsed or Refractory Acute Myeloid Leukaemia	Phase 1
Terminated	`NCT03224819` - Study of Emerfetamab (AMG 673) in Adults With Relapsed/Refractory Acute Myeloid Leukemia (AML)	Early Phase 1
Active, not recruiting	`NCT04070768` - Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113	Phase 1
Active, not recruiting	`NCT03844048` - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial	Phase 3
Active, not recruiting	`NCT04107727` - Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML)	Phase 2
Recruiting	`NCT04920500` - Bioequivalence of Daunorubicin Cytarabine Liposomes in Naive AML Patients	N/A
Recruiting	`NCT04385290` - Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)	Phase 1/Phase 2
Recruiting	`NCT03897127` - Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics	Phase 3
Active, not recruiting	`NCT04021368` - RVU120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome	Phase 1
Recruiting	`NCT03665480` - The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML	Phase 2/Phase 3
Completed	`NCT02485535` - Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant	Phase 1
Enrolling by invitation	`NCT04093570` - A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers	Phase 2
Recruiting	`NCT04069208` - IA14 Induction in Young Acute Myeloid Leukemia	Phase 2
Active, not recruiting	`NCT05744739` - Tomivosertib in Relapsed or Refractory Acute Myeloid Leukemia (AML)	Phase 1
Recruiting	`NCT04969601` - Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings	Phase 1/Phase 2