NCT05456698

Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2022-10-18
• Primary completion: 2025-11-05
• Completion: 2030-11-05
• First posted: 2022-07-13
• Last updated: 2026-04-16

Locations

1 site across 1 country: China