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New hope for rare blood clotting disorder? daratumumab under study

NCT ID NCT07513948

Disease control Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study is collecting information from 40 patients with a rare blood disorder called immune-mediated thrombotic thrombocytopenic purpura (iTTP) who have been treated with daratumumab. The goal is to see how well daratumumab works and how safe it is for patients whose disease did not respond to standard treatments. Researchers will measure response by looking at ADAMTS13 enzyme activity levels and track any side effects.

What this could mean

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

Active substance
daratumumab
What this could lead to
If this study shows daratumumab is effective, it could point toward a new treatment option for people with iTTP who do not respond to standard therapies.
What could go wrong
This is an observational study, not a controlled trial, so results may be less conclusive. The number of participants is small (40), and daratumumab may cause side effects like infections or infusion reactions.

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.

Participants

About 40 people

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

Started

Oct 2025

Expected to finish

Aug 2026

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.

Who is studied

The study includes adult iTTP patients who were treated with daratumumab in the acute phase of disease (i.e., with plasma exchanges and/or caplacizumab ongoing) or during remission (i.e., due to ADAMTS13 relapse or ADAMTS13 activity plasma levels persistently \<20%) from January 2010 to 6 months before the time of data collection. It includes iTTP patients receiving daratumumab either for refractory disease or in ADAMTS13 remission but intolerant to other immune suppressive agents.

Ages

18 to 99 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 a confirmed diagnosis of iTTP (i.e., ADAMTS13 activity \<10% with anti-ADAMTS13 antibodies detected); * aged ≥ 18 years; * male and female patients; * treated with daratumumab for iTTP. Exclusion Criteria: * patients unwilling or unable to provide their informed consent; * follow-up \< 6 months after daratumumab administration.

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Conditions

The condition(s) this trial relates to.

acquired thrombotic thrombocytopenic purpura thrombotic thrombocytopenic purpura

As listed by the trial registrant

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

Thrombotic thrombocytopenic purpura, acquired

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

  • Angelo Bianchi Bonomi Hemophilia and Thrombosis Center

    RECRUITING

    Milan, Italy

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