drugset
drugset / Trial / NCT02981628

Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia

NCT02981628 ↗

Phase 2 Recruiting 80 enrolled Children's Oncology Group National Cancer Institute (NCI) · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them.

Timeline

Start
2017-06-19
Primary completion
2026-12-31
Completion
2026-12-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Inotuzumab Ozogamicin Monoclonal antibody 0.5 mg/m2 Intravenous
Background Asparaginase Erwinia chrysanthemi Protein / enzyme biologic — —
Background Calaspargase Pegol Protein / enzyme biologic — Intravenous
Background Cyclophosphamide Other / unclassified — Intravenous
Background Cytarabine Small molecule — Intravenous
Background Leucovorin Small molecule — Oral
Background Methotrexate Small molecule — Intrathecal
Background Pegaspargase Protein / enzyme biologic — Intravenous
Background Vincristine Small molecule — Intravenous

Indications

B-cell acute lymphoblastic leukemia