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New combo aims to clear leukemia before transplant

NCT ID NCT07443488

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether combining olverembatinib (a targeted pill) with inotuzumab ozogamicin (an antibody-drug conjugate) can clear remaining leukemia cells in adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who still have detectable disease after initial chemotherapy. The goal is to get patients into deep remission so they can proceed to a stem cell transplant. The study will enroll 20 participants and measure how many achieve minimal residual disease (MRD) negativity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Olverembatinib and inotuzumab ozogamicin
What this could lead to
If successful, this combination could help more patients with Ph+ ALL achieve deep remission and successfully receive a stem cell transplant, potentially improving long-term outcomes.
What could go wrong
This is a small, early-phase trial with only 20 participants, so results may not apply broadly. The combination may cause side effects, and it is not yet known if it will improve survival or cure the disease.

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

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

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) Clearly diagnosed acute lymphoblastic leukemia, with Philadelphia chromosome positivity or BCR-ABL fusion gene positivity; with CD22 expression on the surface of leukemia cells; failure to achieve minimal residual disease (MRD) negativity after first induction chemotherapy (BCR-ABL fusion gene level ≥ 10-⁴), where the induction regimen is standard chemotherapy combined with any tyrosine kinase inhibitor targeting BCR-ABL1. * (2) Age greater than or equal to 18 years. * (3) Able to provide informed consent independently. * (4) Must have adequate organ function: renal and hepatic functions as follows: AST, ALT, and ALP less than 2 times the upper limit of normal (ULN), total bilirubin less than 1.5 times ULN; creatinine clearance greater than 50 mL/min; pancreatic function: serum amylase not exceeding 1.5 times ULN, serum lipase not exceeding 1.5 times ULN; normal cardiac function: ejection fraction (EF) \> 60%, pulmonary artery systolic pressure ≤ 50 mmHg. * (5) Negative for HIV, HBV, and HCV. * (6) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2. * (7) Informed consent must be signed before the start of study procedures. For subjects aged 18 years and above, informed consent should be signed by the patient themselves or their immediate family members. Considering the patient's condition, if signing by the patient themselves is detrimental to treatment, the legal guardian or immediate family member may sign the informed consent. Exclusion Criteria: * (1) Mixed lineage leukemia; * (2) Involvement of the central nervous system or extramedullary infiltration; * (3) Patients with concurrent other malignancies; or those assessed by the investigator as having concomitant diseases that severely endanger the patient's life or affect the completion of the study; * (4) Patients with severe allergy to the components or excipients of InO (≥ Grade 3); * (5) History of clinically significant liver diseases, such as hepatic veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS); or severe/uncontrolled liver diseases, such as cirrhosis, decompensated liver disease, acute or chronic hepatitis; * (6) Active cardiac disease, defined as one or more of the following: history of any cardiac or vascular disease; history of uncontrolled or symptomatic angina; myocardial infarction within 6 months prior to study enrollment; history of arrhythmias requiring medication or with severe clinical symptoms; uncontrolled or symptomatic congestive heart failure (\> New York Heart Association \[NYHA\] Class 2); ejection fraction below the lower limit of normal; pulmonary artery systolic pressure \> 50 mmHg on echocardiography; or clinical symptoms related to pulmonary hypertension; * (7) History of severe cardiovascular events (including myocardial infarction, unstable angina, severe arrhythmias, congestive heart failure, etc.) during previous tyrosine kinase inhibitor (TKI) treatment for chronic myeloid leukemia (CML); * (8) Abnormal coagulation function; * (9) Known seropositivity for HIV or active hepatitis C virus; * (10) Patients with psychiatric disorders or other conditions that prevent compliance with study treatment and monitoring requirements; * (11) Inability or unwillingness to sign the consent form; * (12) Pregnant or lactating women; * (13) Patients assessed by the investigator as ineligible due to other special circumstances.

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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.

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  2. A doctor treating you

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