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New drug aims to wipe out lingering leukemia cells after chemo

NCT ID NCT05456698

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

acute lymphoblastic leukemia B-cell acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.