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New drug may help MDS patients need fewer blood transfusions

NCT ID NCT04477850

Disease control Sponsor: Celgene 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a drug called luspatercept in 30 adults from China and Japan who have a bone marrow disorder (MDS) and need regular red blood cell transfusions. The goal was to see if the drug could help them go without transfusions for at least 8 weeks. The drug works by helping the body make more red blood cells, potentially reducing the need for transfusions.

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

30 people

The number who actually took part.

Started

Nov 2020

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

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: * Refractory or intolerant to, or ineligible for, prior Erythropoiesis stimulating agent (ESA) treatment as defined by any one of the following: Refractory to prior ESA treatment, Intolerant to prior ESA treatment, or ESA ineligible. * previously treated with an ESA or granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor, both agents must have been discontinued ≥ 4 weeks prior to date of luspatercept treatment * Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2 Exclusion Criteria: * Prior therapy with disease modifying agents for underlying MDS disease * Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding * Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) or alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) ≥ 3.0 x upper limit of normal (ULN) Other protocol-defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

anemia myelodysplastic syndrome myelodysplastic syndrome with ring sideroblasts Myelodysplastic Syndromes

As listed by the trial registrant

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

Myelodysplastic syndromes

Contacts and locations

Locations

  • Local Institution - 100

    Beijing, 100730, China

  • Local Institution - 101

    Shanghai, 200233, China

  • Local Institution - 102

    Hangzhou, 310006, China

  • Local Institution - 103

    Guangzhou, 510080, China

  • Local Institution - 104

    Suzhu, 215006, China

  • Local Institution - 105

    Guangzhou, 510060, China

  • Local Institution - 106

    Tianjin, 300020, China

  • Local Institution - 107

    Chengdu, Sichuan, 610041, China

  • Local Institution - 108

    Nanjing, 210029, China

  • Local Institution - 109

    Guangzhou, 510515, China

  • Local Institution - 110

    Wuhan, 430022, China

  • Local Institution - 111

    Wenzhou, 325000, China

  • Local Institution - 112

    Nanchang, 330006, China

  • Local Institution - 114

    Shanghai, 0, China

  • Local Institution - 201

    Mibu-Machi, 321-0293, Japan

  • Local Institution - 202

    Shinagawa-ku, Tokyo, 141-8625, Japan

  • Local Institution - 203

    Nagasaki, Nagasaki, 8528511, Japan

  • Local Institution - 204

    Sagamihara, 252-0375, Japan

  • Local Institution - 205

    Osaka, 545-8585, Japan

  • Local Institution - 206

    Kamogawa, 296-8602, Japan

  • Local Institution - 207

    Sendai, 980-8574, Japan

  • Local Institution - 208

    Ōgaki, 503-8502, Japan

  • Local Institution - 209

    Matsuyama, Ehime, 790-8524, Japan

  • Local Institution - 210

    Sayama, Osaka, 5898511, Japan

  • Local Institution - UNK11

    Fukuoka, 810-8563, Japan

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