Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Promyelocytic, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Acute Promyelocytic Leukemia

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Azacitidine

Decitabine

Immunomodulating Agents

Immunoglobulins

azacitidine 75 mg/m2 for 7 days or decitabine 20mg/m2 for 5 days

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)

SGN-CD33A

Phoenix Ho, MD

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.

A Safety Study of SGN-CD33A in AML Patients

A Phase 1 Trial of SGN-CD33A in Patients With CD33-positive Acute Myeloid Leukemia

Seagen Inc.

Anti-Infective Agents

Cytarabine

Daunorubicin

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

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

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

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

Standard dose cytarabine for induction

Given intravenously Day 1 or Days 1 and 4 of each cycle

High dose cytarabine for consolidation

Eric Feldman, MD

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.

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)

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

A Phase 1b Dose-escalation Study of SGN-CD33A in Combination With Standard-of-care for Patients With Newly Diagnosed Acute Myeloid Leukemia

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Safety Study of SGN-CD33A in AML Patients	NCT01902329	Acute Myelogeno... Acute Myeloid L... Acute Promyeloc...	HMA SGN-CD33A	18 Years -	Seagen Inc.
A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML	NCT02326584	Acute Myeloid L... Acute Myelogeno...	Standard dose c... SGN-CD33A Daunorubicin High dose cytar...	18 Years -	Seagen Inc.
A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML	NCT02326584	Acute Myeloid L... Acute Myelogeno...	Standard dose c... SGN-CD33A Daunorubicin High dose cytar...	18 Years -	Seagen Inc.
A Safety Study of SGN-CD33A in AML Patients	NCT01902329	Acute Myelogeno... Acute Myeloid L... Acute Promyeloc...	HMA SGN-CD33A	18 Years -	Seagen Inc.

Spots Global Cancer Trial Database for cd33 antigen

Every month we try and update this database with for cd33 antigen cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.