NCT04546399 — drugset

Summary

This phase II trial studies the effect of nivolumab in combination with blinatumomab compared to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in this study. Blinatumomab is an antibody, which is a protein that identifies and targets specific molecules in the body. Blinatumomab searches for and attaches itself to the cancer cell. Once attached, an immune response occurs which may kill the cancer cell. Nivolumab is a medicine that may boost a patient's immune system. Giving nivolumab in combination with blinatumomab may cause the cancer to stop growing for a period of time, and for some patients, it may lessen the symptoms, such as pain, that are caused by the cancer.

Timeline

Start: 2020-12-17
Primary completion: 2028-06-30
Completion: 2028-06-30

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Blinatumomab	Monoclonal antibody	—	Intravenous
Subject	Nivolumab	Monoclonal antibody	—	Intravenous
Background	Asparaginase Erwinia chrysanthemi	Protein / enzyme biologic	—	Intramuscular
Background	Calaspargase Pegol	Protein / enzyme biologic	—	Intravenous
Background	Cytarabine	Small molecule	—	Intrathecal
Background	Dexamethasone	Small molecule	—	Oral
Background	Hydrocortisone	Other / unclassified	—	Intrathecal
Background	MERCAPTOPURINE ANHYDROUS	Small molecule	—	Oral
Background	Methotrexate	Small molecule	—	Intrathecal
Background	Pegaspargase	Protein / enzyme biologic	—	Intramuscular
Background	Vincristine	Small molecule	—	Intravenous

A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Summary

Timeline

Publications

Drugs

Indications