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New combo therapy aims to boost survival in adult leukemia

NCT ID NCT07495631

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This study is testing a powerful chemotherapy regimen originally designed for children, combined with the targeted drug venetoclax and immunotherapy, in adults aged 14 to 60 with a certain type of acute lymphoblastic leukemia (ALL). The goal is to see if this approach can achieve higher rates of remission and longer survival. Participants will go through several phases of treatment over many months, with the option to add immunotherapy based on their preference.

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 chemotherapy drugs (vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, dexamethasone, cytarabine, 6-mercaptopurine, methotrexate), venetoclax, and immunotherapy (inotuzumab ozogamicin, blinatumomab)
What this could lead to
If successful, this approach could improve remission rates and long-term survival for adults with a hard-to-treat leukemia, potentially offering a more effective treatment option.
What could go wrong
This is a small, early-phase study with only 43 participants, so results may not apply to everyone. The intense chemotherapy and immunotherapy can cause serious side effects like infections and organ damage.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 43 people

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

Started

Apr 2026

Expected to finish

Mar 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

14 to 60 years

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: * Newly diagnosed, previously untreated (except prednisone/hydroxyurea) Ph-negative ALL * Age ≥14 years, ≤60 years * ECOG performance status ≤2 * Adequate organ function (liver, kidney, cardiac) * For patients of childbearing potential: use of effective contraception * Willing and able to provide informed consent Exclusion Criteria: * Burkitt leukemia/lymphoma * Acute leukemia of ambiguous lineage * Pregnancy or lactation * Severe uncontrolled active infection * History of pancreatitis * Uncontrolled diabetes (HbA1c \>7.5%) * Active gastrointestinal bleeding within 6 months * Arterial/venous thrombosis within 6 months * Known HIV positivity * Severe psychiatric illness hindering compliance * Any other condition deemed unsuitable by the investigator

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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

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

  • Blood Diseases Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300020, China

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