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Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Summary
A single-center, single-arm, open-label, interventional, phase II clinical trial to evaluate the efficacy and safety of InO in B-ALL achieved CR/CRi after 1L induction chemotherapy with positive minimal residual disease.
Official title: Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy: A Phase 2, Open-label, Single-arm, Single-center Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
31
Start Date
2022-10-18
Completion Date
2030-11-05
Last Updated
2025-12-24
Healthy Volunteers
No
Conditions
Interventions
Inotuzumab ozogamicin
Patients who achieved CR/CRi had their InO dose at 1.5mg/m2 per cycle (28days/cycle), with 0.5mg/m2 administered on days 1, 8, and 15. Patients received treatment for up to two cycles in the absence of disease progression or unacceptable toxicity.
Locations (1)
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China