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

NCT05940961 | Recruiting Phase 2

• 1 other identifier: szINO
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• the rate of MRD-

  For Ph-negative ALL: undetectable MRD by flow cytometry At the end of Cycle 1 and Cycle 2 (each cycle is 21 days) . For Ph-positive ALL: undetectable MRD by flow cytometry and absence of quantifiable BCR::ABL1 transcript by PCR At the end of Cycle 1 and Cycle 2(each cycle is 21 days).

  At the end of Cycle 1 and Cycle 2(each cycle is 21 days)

Secondary Outcomes (4)

• Progression-Free Survival (PFS)

  1 year

• Overall survival (OS)

  1 year

• Adverse events in hematological system

  1 year

• Adverse events in other organs or systems

  1 year

Study Arms (1)

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

EXPERIMENTAL

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

Drug: Inotuzumab Ozogamicin

Interventions

Inotuzumab Ozogamicin DRUG

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

Also known as: INO

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

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥ 15 and ≤ 65 years.
• Patients diagnosed with CD22+ B-ALL according to 2023 NCCN Acute Lymphoblasts Leukaemias diagnosis standard.
• CD22+ B-ALL patients with MRD recurrence after HSCT. Ph+ ALL patients were eligible if treatment with 1 or more second-generation BCR::ABL1 tyrosine kinase inhibitors (TKIs) had failed,
• ECOG performance status score less than 3.
• Expected survival time #3 months.
• Patients without serious heart, lung, liver, or kidney disease.
• Ability to understand and voluntarily provide informed consent.

You may not qualify if:

• Patients who are allergic to the study drug or drugs with similar chemical structures.
• Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
• Active infection.
• Active bleeding.
• Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
• Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met.
• Liver function abnormalities (total bilirubin \> 1.5 times the upper limit of the normal range, ALT/AST \> 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST \> 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine \> 1.5 times the upper limit of the normal value).
• Patients with a history of clinically significant QTc interval prolongation (male \> 450 ms; female \> 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment.
• Surgery on the main organs within the past six weeks.
• Drug abuse or long-term alcohol abuse that would affect the evaluation results.
• Patients who have received organ transplants (excepting bone marrow transplantation).
• Patients not suitable for the study according to the investigator's assessment.

Sponsors & Collaborators

• Sheng-Li Xue, MD: lead
• Jining Medical University: collaborator
• The Second People's Hospital of Huai'an: collaborator
• The First Affiliated Hospital of Bengbu Medical University: collaborator
• Affiliated Hospital of Nantong University: collaborator
• Suzhou Hospital of Traditional Chinese Medicine: collaborator
• Northern Jiangsu People's Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Interventions

Inotuzumab Ozogamicin

Intervention Hierarchy (Ancestors)

Calicheamicins; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Sheng-Li Xue, MD

CONTACT

0086-0512-67781139; slxue@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 1, 2023
• First Posted: July 11, 2023
• Study Start: August 1, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)