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

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Jul 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Inotuzumab Ozogamicin (InO) to see how effective and safe it is for adults with a type of blood cancer known as Acute Lymphocytic Leukemia (ALL). Specifically, the trial focuses on patients who have recently been treated with chemotherapy and are in a state of remission, but still have detectable cancer cells in their blood, a situation known as minimal residual disease (MRD). The goal is to find out if InO can help these patients achieve better outcomes.

To participate in this trial, you need to be at least 18 years old and have been diagnosed with B-cell ALL. You should have completed your first round of chemotherapy and be in remission, but still show signs of MRD. You also need to have normal functioning of your major organs and overall good health. During the trial, participants will receive InO and be monitored for its effects and any potential side effects. It’s important that participants are willing to sign a consent form and follow the study's guidelines. If you or a loved one meet these criteria and are interested, you may want to talk to your healthcare provider for more information.

Gender

ALL

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