New drug aims to wipe out lingering leukemia cells after chemo
NCT ID NCT05456698
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests the drug inotuzumab ozogamicin in 31 adults with B-cell acute lymphoblastic leukemia (ALL) who achieved remission after initial chemotherapy but still have tiny amounts of leukemia cells detectable (called minimal residual disease, or MRD). The goal is to see if the drug can make those cells disappear. Participants receive up to two cycles of the drug. The study is active but no longer recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- inotuzumab ozogamicin (a targeted antibody-drug conjugate)
- What this could lead to
- If successful, this could offer a way to eliminate leftover leukemia cells after initial chemotherapy, potentially reducing relapse risk in adults with ALL.
- What could go wrong
- This is a small, early-phase trial with no comparison group. The drug may cause serious side effects like liver toxicity, and it is not yet known if clearing these cells will improve long-term survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
31 people
The number who actually took part.
- Started
-
Oct 2022
- Expected to finish
-
Nov 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
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Other studies related to the condition(s) this trial covers.
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