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

NCT ID: NCT05456698

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-18
• Study Completion Date: 2030-11-05

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Inotuzumab Ozogamicin

Each subject will be treated with Inotuzumab Ozogamicin

Group Type: EXPERIMENTAL

Inotuzumab ozogamicin

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

CMC-544

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Age ≥18 years

3. ECOG PS score: 0 to 2

4. Functions of the main organs are normal, if the following criteria are met:

1. Total bilirubin (BIL) ≤ 1.5 × upper limit of normal (ULN)

2. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × ULN

3. Serum creatinine ≤ 1.5 × ULN

4. Creatinine clearance ≥ 30 ml/min

5. No active or co-existing malignancy with a life expectancy of less than 12 months

6. Patients are voluntarily enrolled into the study and have good compliance, and the Informed Consent Form (ICF) needs to be signed.

Exclusion Criteria

1. Mixed lineage leukemia

2. Clinically significant liver disease such as history of veno-occlusive disease (VOD)/ sinusoidal obstruction syndrome (SOS)

3. Patients with severe and / or uncontrolled diseases, such as:

1. 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)

2. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis

3. Known to be human immunodeficiency virus positive (HIV+)

4. Active and uncontrolled disease/infection as judged by the treating physician

5. Active central nervous system (CNS) or extramedullary disease

6. 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

4. Pregnant or nursing women

5. Unable or unwilling to sign the consent form

6. Monoclonal antibodies therapy within 2 weeks before study entry

7. Radiotherapy or cancer chemotherapy (except for induction chemo) or any investigational drug within 2 weeks before study entry

8. Patients who have severe allergies (≥ grade 3) to active ingredients and any excipients of InO

9. Patients in other situations who are evaluated by the investigator to be ineligible

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

IIT2022011

Identifier Type: -

Identifier Source: org_study_id