drugset
drugset / Trial / NCT02101853

Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia

NCT02101853 ↗

Phase 3 Active not recruiting 669 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase III trial studies how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Immunotherapy with blinatumomab may allow the body's immune system to attack and destroy some types of leukemia cells. It is not yet known whether blinatumomab is more effective than standard combination chemotherapy in treating relapsed B-cell acute lymphoblastic leukemia.

Timeline

Start
2014-12-17
Primary completion
2021-06-30
Completion
2026-09-16

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Blinatumomab Monoclonal antibody — Intravenous
Background Cyclophosphamide Other / unclassified — Intravenous
Background Cytarabine Small molecule — Intrathecal
Background Dexamethasone Small molecule — Oral
Background Etoposide Small molecule — Intravenous
Background Hydrocortisone Other / unclassified — Intrathecal
Background Leucovorin Small molecule — Intravenous
Background MERCAPTOPURINE ANHYDROUS Small molecule — Oral
Background Methotrexate Small molecule — Intrathecal
Comparator Mitoxantrone Small molecule — Intravenous
Background Pegaspargase Protein / enzyme biologic — Intravenous
Background Thioguanine Small molecule — Oral
Background Vincristine Small molecule — Intravenous
Comparator asparaginase Protein / enzyme biologic — Intramuscular

Indications

B-cell acute lymphoblastic leukemia