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Cheap drug combo may tame tough anemia

NCT ID NCT04324411

Disease control Sponsor: Peking Union Medical College Hospital 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This trial tests a combination of two drugs, sirolimus and all-trans retinoic acid (ATRA), for people with autoimmune anemia that has not responded to standard treatments. Autoimmune anemia occurs when the immune system attacks red blood cells, causing fatigue and other symptoms. The study aims to see if this combination can improve response rates and reduce side effects compared to existing therapies.

What this could mean

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

Active substance
sirolimus and all-trans retinoic acid (ATRA)
What this could lead to
If it works, this combination could offer an effective, affordable treatment option for people with autoimmune anemia who have not responded to standard therapies.
What could go wrong
This is a Phase 4 trial, but the combination is new for this condition. Some patients may still not respond, and side effects like kidney issues or gum problems 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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Started

Apr 2020

Expected to finish

Sep 2023

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 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. diagnosed as autoimmune anemia (autoimmune hemolytic anemia, pure red aplastic anemia, events syndrome) without organ complications; 2. ineffective, relapsed or intolerant patients who have been treated with at least one kind of sufficient current conventional drug (steroids, CsA, CD20 monoclonal antibody, tacrolimus and others) ; 3. normal cardiac function, liver function (ALT/AST ≤ 3.0 × ULN) and renal function (serum creatinine ≤ 1 × ULN); 4. no secondary disease; 5. unable to accept hematopoietic stem cell transplantation; 6. ECoG score ≤ 2; 7. able to sign the informed consent form. Exclusion Criteria: 1. failure to make a definite diagnosis; 2. AIA secondary to known diseases such as systemic lupus erythematosus, rheumatoid arthritis, tumor or other inflammatory diseases; 3. severe hepatorenal insufficiency (creatinine, transaminase more than 3 times of the upper limit of normal value); 4. uncontrollable systemic infection or other serious diseases; 5. pregnant or lactating women; 6. patients with mental disease who are unable to sign the informed consent; 7. taking other AIA drugs or stopping the drugs for less than 3 months; 8. allergic to the study drug; 9. participation in other clinical studies; 10. patients in any other circumstances considered unsuitable by the investigator.

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Conditions

The condition(s) this trial relates to.

autoimmune hemolytic anemia Evans syndrome pure red-cell aplasia

As listed by the trial registrant

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

Autoimmune anemia

Contacts and locations

Locations

  • Peking union medical college hospital

    Beijing, China

More trials for these conditions

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