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Inotuzumab Ozogamicin in the Treatment of MRD+ After HSCT of ALL

NCT05940961 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-11-21

No results posted yet for this study

Summary

As part of postremission consolidative therapy, the decision to proceed with hematopoietic stem cell transplantation is a recommendable regimen in ALL therapy. However, The recurrence rate is high after transplantation. Minimal Residual Disease (MRD) is an important factor affecting the effect of HSCT. The hematologic recurrence rate of MRD-positive patients with adult ALL is high.

MRD- is associated with better prognosis. Therefore, maintaining MRD- after transplantation is necessary for long-term survival. The purpose of this study is to explore the efficacy and safety of Inotuzumab Ozogamicin in the treatment of minimal residual disease recurrence after HSCT of ALL patients.

Conditions

  • ALL
  • MRD-positive
  • Hematopoietic Stem Cell Transplantation

Interventions

DRUG

Inotuzumab Ozogamicin

intravenous infusion: Cycle 1: D1 0.8mg/m2, D8 0.5mg/m2, D15 0.5mg/m2, if the MRD turn negative, cycle 2: D1 0.5mg/m2, D8 0.5mg/m2, D15 0.5mg/m2， if not，cycle 2: D1 0.8mg/m2, D8 0.5mg/m2, D15 0.5mg/m2

Sponsors & Collaborators

  • Jining Medical University

    collaborator OTHER

  • The Second People's Hospital of Huai'an

    collaborator OTHER

  • The First Affiliated Hospital of Bengbu Medical University

    collaborator OTHER

  • Affiliated Hospital of Nantong University

    collaborator OTHER

  • Suzhou Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • Northern Jiangsu People's Hospital

    collaborator OTHER

  • Sheng-Li Xue, MD

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2026-08-01
Completion
2026-08-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05940961 on ClinicalTrials.gov