MedTrace Logo

Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia

NCT06427330 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-07-30

No results posted yet for this study

Summary

To learn about the safety of post-HSCT two dose Inotuzumab Ozogamicin to participants with high risk B cell acute lymphoblastic leukemia(B-ALL). Also, to learn if giving Inotuzumab Ozogamicin to post-HSCT patients with high-risk B- ALL can help to reduce relapse and prolong disease free survival and overall survival.

Conditions

  • Acute Lymphoid Leukemia

Interventions

DRUG

Inotuzumab ozogamicin

1. st dose is given after D+60：inotuzumab 0.3mg/m2 2. nd dose is given after 1 month：inotuzumab 0.6mg/m2

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-02
Primary Completion
2025-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

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 NCT06427330 on ClinicalTrials.gov