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New combo therapy aims to beat leukemia without harsh chemo

NCT ID NCT07564453

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing a new treatment strategy for adults newly diagnosed with a type of blood cancer called B-cell acute lymphoblastic leukemia (B-ALL). The approach combines a reduced-dose chemotherapy with a full course of the immunotherapy drug blinatumomab, and may also include CAR-T cell therapy or a stem cell transplant for some patients. The goal is to improve the chance of staying cancer-free for at least two years while reducing side effects. The study plans to enroll 101 people aged 15 to 65.

What this could mean

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

Active substance
Blinatumomab (an immunotherapy drug) combined with reduced-dose chemotherapy
What this could lead to
If successful, this approach could offer a more effective and less toxic first-line treatment for B-cell acute lymphoblastic leukemia, potentially improving long-term survival and reducing the need for intensive chemotherapy.
What could go wrong
This is a single-arm phase 2 trial with only 101 participants, so results may not be generalizable. The combination therapy may cause significant side effects, and the long-term benefits are not yet proven.

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 101 people

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

Started

Apr 2025

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

15 to 65 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. Age ≥15 years and ≤65 years. 2. Newly diagnosed Ph-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) according to WHO diagnostic criteria, with CD19 expression ≥ 20% 3. De novo patients with no prior induction therapy (excluding hydroxyurea and corticosteroid use for ≤ 5 days) 4. ECOG performance status score 0-3. 5. Liver function: Total bilirubin ≤ 3 times the upper limit of normal (ULN); alanine transaminase (ALT) ≤ 3×ULN; aspartate transaminase (AST) ≤ 3×ULN; (leukemic infiltration is excluded). 6. Renal function: Creatinine clearance rate (CrCl) ≥ 30 mL/min 7. Able to understand and voluntarily participate in the study, and provide written informed consent Exclusion Criteria: 1. Philadelphia chromosome-positive (Ph+, BCR-ABL1+) ALL 2. T-cell acute lymphoblastic leukemia 3. Mature B-cell leukemia/lymphoma, B-cell lymphoblastic lymphoma, extramedullary invasion 4. Acute mixed phenotype acute leukemia (MPAL) 5. Central nervous system (CNS) leukemia 6. HIV infection 7. Positive HBV-DNA or HCV-RNA 8. New York Heart Association (NYHA) functional class ≥ II, or other conditions deemed unsuitable for enrollment by the investigator 9. Pregnant or lactating patients 10. Patients who refuse to enroll in the study

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Conditions

The condition(s) this trial relates to.

B-cell acute lymphoblastic leukemia B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) Burkitt lymphoma

As listed by the trial registrant

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

B acute lymphoblastic leukemia, philadelphia chromosome negative

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

    RECRUITING

    Suzhou, Jiangsu, 215000, China

More trials for these conditions

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