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New combo aims to cut transfusions for blood disorder patients

NCT ID NCT07338344

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether adding low-dose thalidomide to luspatercept can reduce the number of blood transfusions needed by adults with transfusion-dependent β-thalassemia. 78 participants will be randomly assigned to receive either the combination or luspatercept alone for 48 weeks. The main goal is to see if the combo leads to a 50% or greater reduction in transfusion needs.

What this could mean

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

Active substance
luspatercept combined with low-dose thalidomide
What this could lead to
If it works, this combination could reduce the need for regular blood transfusions in people with β-thalassemia, improving their quality of life.
What could go wrong
This is a small Phase 2 trial, so results may not apply to everyone. The combination may cause side effects or not work better than luspatercept alone.

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 78 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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 75 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: * Age ≥ 18 years, regardless of gender; * Patients with transfusion-dependent β-thalassemia; * Intended treatment with rotecept combined with low-dose thalidomide or rotecept alone; * Requires regular red blood cell transfusions (6-30 RBC units (International Units) within 24 weeks prior to randomization, with a transfusion-free interval of ≤ 42 days); * ECOG performance status 0-1; * Patients (or legal guardians) voluntarily participate in the study and provide signed informed consent. Exclusion Criteria: * A diagnosis of α-thalassemia minor, Hb Bart's edema, hemoglobin S/β-thalassemia, or myelodysplastic anemia (combination of β-thalassemia and α-thalassemia is permitted); * Anemia related to nutritional deficiency, anemia of chronic disease, autoimmune hemolytic anemia, or any other hemolytic anemia (e.g., severe G6PD deficiency, pyruvate kinase deficiency); * A bleeding disorder manifesting as frequent bleeding (e.g., menorrhagia, epistaxis, coagulopathy); * Hemolysis unrelated to thalassemia within the past 8 weeks, such as after use of hemolytic-inducing medications (e.g., antimalarials, nonsteroidal anti-inflammatory drugs \[NSAIDs\]); * Use of long-term anticoagulant therapy, unless discontinued at least 28 days before randomization. Prophylactic anticoagulant therapy for surgery or high-risk procedures, as well as low-molecular-weight heparin and long-term aspirin therapy for superficial venous thrombosis, are permitted. * Use of thalidomide alone, erythropoiesis-stimulating drugs (ESA), or hydroxyurea within the past 24 weeks. * Use of long-term systemic glucocorticoids within the past 12 weeks. * Use of cytotoxic drugs, immunosuppressants, or other investigational drugs within the past 28 days. * HIV positive and/or active HCV or HBV infection. * Hepatic and renal insufficiency (liver insufficiency, i.e., aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≥3× upper limit of normal (ULN); renal insufficiency, i.e., serum creatinine ≥3× upper limit of normal (ULN) or creatinine clearance less than 30). mL/min), history of malignancy (unless cured and/or with no known active disease); * Women who are pregnant, plan to become pregnant during the study, or are breastfeeding; * Previous thalassemia gene therapy or hematopoietic stem cell transplantation (HSCT); * Platelet count \< 70 × 109/L, if not associated with hypersplenism, or platelet count \> 1,000 × 109/L; * Other conditions deemed unsuitable for participation in this clinical trial 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

    8 sites. 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

  • Affiliated Hospital of Youjiang Medical College for Nationalities

    RECRUITING

    Baise City, Guangxi, 533000, China

  • Baise People's Hospital

    RECRUITING

    Baise City, Guangxi, 533000, China

  • Liuzhou People's Hospital

    RECRUITING

    Liuzhou, Guangxi, 545007, China

  • Liuzhou Workers' Hospital

    RECRUITING

    Liuzhou, Guangxi, 545007, China

  • Southern Medical University Shenzhen Hospital

    RECRUITING

    Shenzhen, Guangdong, 518100, China

  • The First Affiliated Hospital of Guangxi Medical University

    RECRUITING

    Naning, 530000, China

  • Yulin First People's Hospital

    RECRUITING

    Yulin, Guangxi, 537000, China

  • Yunnan Provincial First People's Hospital

    RECRUITING

    Kunming, Yunnan, 650100, China