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New combo aims to fix transfusion failure in blood cancer patients

NCT ID NCT07635511

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This phase 3 trial tests whether acalabrutinib (a BTK inhibitor) alone or with bortezomib can lower harmful HLA antibodies that cause platelet transfusions to fail in blood cancer patients. About 42 adults with platelet transfusion refractoriness and high antibody levels will be enrolled. The goal is to improve transfusion success and reduce bleeding.

What this could mean

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

Active substance
acalabrutinib maleate and bortezomib
What this could lead to
If successful, this could offer a way to make platelet transfusions work again for blood cancer patients, reducing bleeding risk and improving survival.
What could go wrong
This is a small early-phase trial (42 people) testing a new combination. It may not work for everyone, and side effects from the drugs are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 42 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

May 2029

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 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: * Patients with hematological malignancies and platelet transfusion refractoriness (24-hour CCI \< 4.5×10⁹/L or PPR \< 20%), and with the highest MFI of HLA antibodies \> 8000 ; * Age 18-65 years, both male and female; * ECOG performance status 0-3; * Expected survival \> 6 months; * Patients must be able to understand and be willing to participate in this study, and sign an informed consent form. Exclusion Criteria: * Hypersensitivity to acalabrutinib, bortezomib, or excipients; * Major organ bleeding (central nervous system, lung, intestines) or grade ≥3 bleeding; * Hypersplenism; * Concurrent use of drugs that may cause excessive platelet consumption (amphotericin B, vancomycin, ATG, interferon, etc.); * Disseminated intravascular coagulation, microangiopathic hemolytic anemia; * Underlying diseases of vital organs: such as malignant arrhythmia, myocardial infarction, chronic cardiac insufficiency, decompensated liver insufficiency, renal insufficiency, severe coagulation abnormalities, etc.; persistent fever (\>38.0°C) for more than 3 days; clinically uncontrolled active infection (including bacterial, fungal, or viral infections), but patients under effective drug therapy are not excluded; * Concurrent other progressive malignancies; * Patients with cardiac insufficiency: ejection fraction (EF) \<30%, NYHA class ≥III cardiac insufficiency; * Pregnant or lactating women; * Expected survival \<60 days; * Currently participating in other clinical drug trials.

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm

As listed by the trial registrant

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

Hematological malignancies HLA antibodies Platelet transfusion refractoriness (PTR)

How to take part

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  1. 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 ↗

  2. A doctor treating you

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More trials for these conditions

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