Inotuzumab Ozogamicin in High-Risk B-ALL
Phase 3
4,997
about 10 years
0.999336057550805–25
203 sites in AK, AL, AR +46
About this study
Researchers are testing whether adding inotuzumab ozogamicin to standard chemotherapy improves outcomes for patients with high-risk B-cell Acute Lymphoblastic Leukemia (B-ALL), mixed phenotype acute leukemia, and B-lymphoblastic lymphoma. The trial also compares outcomes of patients treated with or without inotuzumab ozogamicin.
Based on ClinicalTrials.gov records.
What participants do
- 1.Questionnaire Administration
- 2.Receive Inotuzumab Ozogamicin
- 3.Receive Radiation Therapy
- +3 more
Participation effort
Estimated from trial records. Details can vary by site.
Logistics difficulty varies by site location and availability.
Trial highlights
Treatment details
Auto-extracted from trial records to preview treatments and outcomes.
blinatumomab, calaspargase pegol, cyclophosphamide (Alkylating chemotherapy; crosslinks DNA strands), cytarabine, Antineoplastic Agent [TC] (DNA Polymerase Inhibitors), dexamethasone, Antineoplastic Agent [TC] (Topoisomerase 2 Inhibitors), inotuzumab ozogamicin
injection, intravenous, infusion, injection (Injection), ocular, oral (Oral Tablet), oral (Disintegrating Oral Tablet), oral
Primary: Post-induction 5-year event-free survival (EFS)
Secondary: 5-year DFS for favorable risk subset of NCI HR B-ALL (HR favorable) when treated with mBFM chemotherapy with a single high-dose methotrexate (HD MTX) Interim Maintenance (IM) phase and treatment duration of 2 years from the start of IM regardless of sex, 5-year EFS for patients with disseminated (Murphy stage III-IV) B-cell lymphoblastic lymphoma (B-LLy) receiving mBFM HR B-ALL therapy that includes a second IM phase with C-MTX, 5-year event-free survival (EFS) for patients with mixed phenotype acute leukemia (MPAL) receiving mBFM HR B-ALL therapy that includes a second IM phase with Capizzi escalating intravenous MTX without leucovorin rescue+pegaspargase or calaspargase pegol, Health-related quality of life (HRQoL) for HR B-ALL, Incidence of adverse events for the integration of inotuzumab ozogamicin into the mBFM chemotherapy backbone in HR B-ALL, Incidence of symptomatic AEs for patients with HR B-ALL
diagnostic, biopsy, imaging, radiation
Oncology