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New hope for rare leukemia: drug cocktail aims for remission

NCT ID NCT07573670

Disease control Sponsor: The First Affiliated Hospital of Soochow University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a combination of two drugs (Bcl-2 inhibitor and azacitidine) in people newly diagnosed with a rare and aggressive leukemia called mixed phenotype acute leukemia (MPAL). About 52 participants will receive the treatment, with an extra drug added for a specific subtype. The goal is to see if this approach can achieve complete remission and help patients move to a stem cell transplant, which may offer long-term control.

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 52 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jun 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

16 to 70 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: 1. Aged 16 to 70 years old 2. Newly diagnosed MPAL confirmed by the 2022 WHO/ICC classification criteria for hematopoietic and lymphoid neoplasms 3. Previously untreated; use of glucocorticoids or hydroxyurea for ≤7 days to control tumor burden before enrollment is allowed, no other systemic anti-leukemia therapy 4. ECOG performance status score 0-3 5. No severe combined heart, brain, lung, liver or kidney disease, judged by the investigator to tolerate the study regimen 6. Able to understand and voluntarily sign a written informed consent form Exclusion Criteria: 1. BCR::ABL-positive MPAL patients 2. Presence of active, uncontrolled infection 3. Known uncontrolled active central nervous system leukemia (CNSL) 4. Life-threatening extramedullary disease requiring urgent radiotherapy or surgical debulking 5. Severe cardiac insufficiency with left ventricular ejection fraction (LVEF) \<40% 6. Previous receipt of systemic anti-leukemia therapy 7. Pregnant or lactating female subjects 8. Judged by the investigator to be ineligible for the study for other reasons

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Conditions

The condition(s) this trial relates to.

mixed phenotype acute leukemia

As listed by the trial registrant

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

Newly diagnosed mixed phenotype acute leukemia

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

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000, China