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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

NCT05456698 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2026-04-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-18
Primary Completion
2025-11-05
Completion
2030-11-05

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05456698 on ClinicalTrials.gov