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

Phase 2

Recruiting

• Conditions: Acute Lymphocytic Leukemia
• Interventions: Drug: Inotuzumab ozogamicin

• Registration Number: NCT05456698
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-07-11
• Study First Posted: 2022-07-13
• Study Start: 2022-10-18
• Status Verified: 2024-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inotuzumab Ozogamicin	Inotuzumab ozogamicin	Each subject will be treated with Inotuzumab Ozogamicin

Primary Outcome Measures

Name	Time	Method
MRD negativity rate within the first treatment cycle	At the end of Cycle 1 (each cycle is 28 days)	MRD negativity is defined as no presence of small numbers of leukemic cells detected by the flow cytometry after remission

Secondary Outcome Measures

Name	Time	Method
Complete MRD response rates	At the end of Cycle 1 and Cycle 2, respectively (each cycle is 28 days)	Complete MRD response is defined as no presence of small numbers of leukemic cells detected by the flow cytometry after remission
Overall Survival (OS)	Up to 5 years from enrollment	OS is defined as the time from enrollment to date of death due to any cause.
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)	The duration of MRD response was analyzed as the time from onset of MRD negativity until MRD or hematological relapse or date of last confirmation of negative MRD status.
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)	The variation of MRD level from baseline to post cycle 1, cycle 2, respectively
Relapse-free Survival (RFS)	Up to 5 years from enrollment	RFS is defined as the time from the date of CR until the date of relapse or death

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital; 🇨🇳 Tianjin, Tianjin, China