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New combo therapy aims to boost leukemia remission with fewer side effects

NCT ID NCT06387121

Disease control Sponsor: Institute of Hematology & Blood Diseases Hospital, China Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new treatment approach for adults newly diagnosed with a specific type of leukemia (Ph-negative B-cell acute lymphoblastic leukemia). The treatment combines low-dose chemotherapy with several targeted immunotherapy drugs. The goal is to see if this gentler regimen can help more patients achieve a deep remission (no detectable cancer cells) and improve long-term survival. The study will enroll 53 adults and track their response and side effects.

What this could mean

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

Active substance
a combination of low-dose chemotherapy (vincristine, cyclophosphamide, dexamethasone, 6-mercaptopurine, methotrexate) and immuno-targeted drugs (venetoclax, inotuzumab ozogamicin, blinatumomab)
What this could lead to
If successful, this could offer a more tolerable and effective treatment option for adults with B-cell acute lymphoblastic leukemia, potentially improving remission rates and survival without the need for intensive chemotherapy.
What could go wrong
This is a small, early-phase (phase 2) single-arm study with only 53 participants, so results may not apply to all patients. The combination of drugs may still cause significant side effects, and the treatment may not work as hoped.

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 53 people

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

Started

Apr 2024

Expected to finish

Dec 2028

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. Newly diagnosed Ph-negative B-cell acute lymphoblastic leukemia according to World Health Organization (WHO) 2016 criteria 2. CD22 positive tumor cells 3. ≥18 years of age 4. Estimated survival ≥3 months 5. Consent and effective contraception for men and women of childbearing potential 6. Understanding and signing of informed consent forms and agreement to comply with study requirements. Exclusion Criteria: 1. Burkitt lymphoma/leukemia 2. acute leukemias of ambiguous lineage 3. pregnant women 4. severe uncontrolled active infection 5. previous history of chronic liver disease (e.g. cirrhosis) or venous occlusive liver disease (VOD) or sinus obstruction syndrome (SOS) 6. History of clinically significant ventricular arrhythmia, syncope of unknown origin (not vasovagal) or sinoatrial block or higher degree atrioventricular (AV) block Chronic bradycardia state (unless permanent pacemaker implanted) 7. New or chronic hepatitis B or C infection (positive for hepatitis B surface antigen and anti-hepatitis C antibody, respectively) or known HIV seropositivity. HIV testing may need to be performed according to local regulations or practices 8. Psychiatric disorders likely to prevent the subject from completing treatment or informed consent 9. Other conditions considered unsuitable for the study by the investigator.

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Conditions

The condition(s) this trial relates to.

B-cell acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma precursor lymphoblastic lymphoma/leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Precursor cell lymphoblastic leukemia-lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Institute of Hematology & Blood Diseases Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, China

More trials for these conditions

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