Clinical trial NCT05456698: Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy
Official title: Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy: A Phase 2, Open-label, Single-arm, Single-center Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acute Lymphocytic Leukemia
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: MRD negativity rate within the first treatment cycle
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes:
measure: Complete MRD response rates
timeFrame: At the end of Cycle 1 and Cycle 2, respectively (each cycle is 28 days)
measure: Duration of MRD negativity rate
timeFrame: From enrollment to the end of Cycle 1 or Cycle 2, which achieves MRD negative first (each cycle is 28 days)
measure: MRD level variation from baseline to post cycle 1, cycle 2 in patients with detectable MRD, respectively
timeFrame: From enrollment to the end of Cycle 1 and Cycle 2, respectively (each cycle is 28 days)
measure: Relapse-free Survival (RFS)
timeFrame: Up to 5 years from enrollment
measure: Overall Survival (OS)
timeFrame: Up to 5 years from enrollment
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
state: Tianjin
Study officials:
References: