Using Inotuzumab Ozogamicin to treat adults with a specific type of leukemia after initial chemotherapy
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
This study is testing if a drug called Inotuzumab Ozogamicin can help adults with a specific type of leukemia who have had some success with initial chemotherapy but still have leftover cancer cells.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT05456698 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial evaluates the efficacy and safety of Inotuzumab Ozogamicin in adult patients diagnosed with B-cell Acute Lymphocytic Leukemia (B-ALL) who have achieved hematologic complete remission but remain positive for minimal residual disease after first-line induction chemotherapy. The study is a single-center, single-arm, open-label design, focusing on patients with a specific molecular disease threshold. Participants will receive Inotuzumab Ozogamicin to assess its effectiveness in eliminating residual leukemia cells.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed B-ALL in complete remission but with detectable minimal residual disease.
Not a fit: Patients with mixed lineage leukemia or significant liver disease may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with B-ALL who have minimal residual disease after initial chemotherapy.
How similar studies have performed: Other studies have shown promise with similar approaches using targeted therapies in leukemia, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tianjin, Tianjin
- Institute of Hematology & Blood Diseases Hospital — Tianjin, Tianjin, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.