Inotuzumab Ozogamicin in High-Risk B-ALL
Phase 3
4,997
about 10 years
0.999336057550805–25
203 sites in AK, AL, AR +46
What this study is about
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.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Questionnaire Administration
- 2.Receive Inotuzumab Ozogamicin
- 3.Receive Radiation Therapy
- +3 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
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