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

NCT05456698 | Active Not Recruiting Phase 2

• 1 other identifier: IIT2022011
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• MRD negativity rate within the first treatment cycle

  MRD negativity is defined as no presence of small numbers of leukemic cells detected by the flow cytometry after remission

  At the end of Cycle 1 (each cycle is 28 days)

Secondary Outcomes (5)

• Complete MRD response rates

  At the end of Cycle 1 and Cycle 2, respectively (each cycle is 28 days)

• Duration of MRD negativity rate

  From enrollment to the end of Cycle 1 or Cycle 2, which achieves MRD negative first (each cycle is 28 days)

• MRD level variation from baseline to post cycle 1, cycle 2 in patients with detectable MRD, respectively

  From enrollment to the end of Cycle 1 and Cycle 2, respectively (each cycle is 28 days)

• Relapse-free Survival (RFS)

  Up to 5 years from enrollment

• Overall Survival (OS)

  Up to 5 years from enrollment

Study Arms (1)

Inotuzumab Ozogamicin

EXPERIMENTAL

Each subject will be treated with Inotuzumab Ozogamicin

Drug: Inotuzumab ozogamicin

Interventions

Inotuzumab ozogamicin DRUG

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.

Also known as: CMC-544

Inotuzumab Ozogamicin

Eligibility Criteria

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

You may qualify if:

• New diagnosed B-ALL in hematologic complete remission (CR) after 1L induction chemotherapy with MRD positive. Molecular disease or MRD is defined by a value of at least of 10-4 (0.01%) by multicolor flow cytometry.
• Age ≥18 years
• ECOG PS score: 0 to 2
• Functions of the main organs are normal, if the following criteria are met:
• Total bilirubin (BIL) ≤ 1.5 × upper limit of normal (ULN)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × ULN
• Serum creatinine ≤ 1.5 × ULN
• Creatinine clearance ≥ 30 ml/min
• No active or co-existing malignancy with a life expectancy of less than 12 months
• Patients are voluntarily enrolled into the study and have good compliance, and the Informed Consent Form (ICF) needs to be signed.

You may not qualify if:

• Mixed lineage leukemia
• Clinically significant liver disease such as history of veno-occlusive disease (VOD)/ sinusoidal obstruction syndrome (SOS)
• Patients with severe and / or uncontrolled diseases, such as:
• Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, severe uncontrolled arrhythmias; uncontrolled blood pressure (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg)
• Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis
• Known to be human immunodeficiency virus positive (HIV+)
• Active and uncontrolled disease/infection as judged by the treating physician
• Active central nervous system (CNS) or extramedullary disease
• Patients who have other malignant tumors at the same time; patients who are evaluated by the investigator to have concomitant diseases that seriously endanger the safety of the patients or affect the patients to complete the study
• Pregnant or nursing women
• Unable or unwilling to sign the consent form
• Monoclonal antibodies therapy within 2 weeks before study entry
• Radiotherapy or cancer chemotherapy (except for induction chemo) or any investigational drug within 2 weeks before study entry
• Patients who have severe allergies (≥ grade 3) to active ingredients and any excipients of InO
• Patients in other situations who are evaluated by the investigator to be ineligible

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Inotuzumab Ozogamicin

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

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

Study Design

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

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: July 13, 2022
• Study Start: October 18, 2022
• Primary Completion: November 5, 2025
• Study Completion (Estimated): November 5, 2030
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)