ClinicalTrials.gov record NCT07513948

Daratumumab in Immune-mediated Thrombotic Thrombocytopenic Purpura

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

DarTTP: an Observational, International, Multicentric Study on Daratumumab in Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old to 99 years old
SexAll
LocationItaly
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a retrospective, observational international study collecting data on adults with acquired (immune) TTP who were treated with daratumumab. It aims to gather more evidence about daratumumab’s safety and effects on ADAMTS13 activity, especially in patients refractory or intolerant to prior immunosuppressive treatments. The main measure is the proportion of patients with ADAMTS13 activity >20% at 6 months after the first daratumumab dose.

What it is studying. The study is collecting past clinical data to evaluate safety and biological response to daratumumab in adults with iTTP who received the drug either for refractory disease or because they could not tolerate other immunosuppressive treatments. The main laboratory outcome is whether ADAMTS13 activity rises above 20% of normal at 6 months from the first daratumumab dose. The study also records adverse events and how long any ADAMTS13 response lasts.

What the researchers hope to learn. To collect larger-scale evidence on daratumumab’s safety in iTTP, the proportion of patients who reach ADAMTS13 activity >20% after treatment, and the duration of ADAMTS13 relapse-free survival. The study aims to better characterize adverse events using CTCAE v5.0 and to summarize response durability up to three years.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Data about efficacy and safety of daratumumab in iTTP refractory or intolerant to standard immunosuppressive treatments are scarce. Therefore, the investigators aim at collecting evidence on a larger number of patients through a collaborative, international study.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

iTTP in an autoimmune disease caused by autoantibodies directed against the metalloproteinase ADAMTS13. Rituximab is the standard immune suppressive treatment suggested from international guidelines. However, 10-15% of patients do not achieve a sustained ADAMTS13 remission with rituximab, and a significant portion of responders eventually need re-treatment after 12 months or less. Other therapeutic options are scarce and based on old immunosuppressive agents or splenectomy, all burdened by relevant toxicity and lack of solid efficacy data. Recently, targeting CD20-negative long-lived plasma cells appears to be a promising strategy in refractory iTTP. The anti-CD38 monoclonal antibody daratumumab has been employed in selected iTTP patients with good results. However, evidence stems only from isolated case reports. The DarTTP study aims to collect evidence on a larger number of patients about the efficacy and safety of daratumumab in iTTP subjects who are refractory or intolerant to previous immunosuppressive treatments. The primary endpoint is the proportion of patients with ADAMTS13 activity levels above 20% of normal at 6 months from the first daratumumab administration.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a retrospective observational study: investigators will collect and review existing medical-record data about each participant's daratumumab treatment, ADAMTS13 activity levels, adverse events, and timing of responses and relapses. No study-assigned treatment is given as part of this research. Outcomes will be assessed from the first daratumumab dose up to specified windows (e.g., 12 weeks after last dose for response; safety up to 24 weeks; relapse-free follow-up up to 3 years) when those data are available. The registry record does not specify whether additional clinic visits, tests, or new samples are required for participation.

How the study is structured. A retrospective, case-only observational study that gathers existing medical records and data from adult iTTP patients who were treated with daratumumab; no treatments are assigned by the study.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Italy. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on thrombotic thrombocytopenic purpura

Clinical trials18 trials listed for thrombotic thrombocytopenic purpuraEvery trial the registry lists for thrombotic thrombocytopenic purpura, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in thrombotic thrombocytopenic purpura researchLatest monthly update: September 2026. Includes: Caplacizumab use. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Oct 1, 2025
Primary completion
June 2026 (estimated)
Study completion
August 2026 (estimated)
Target enrollment
40 participants (estimated)
Last updated on registry
Apr 14, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
immunosuppressive
A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
primary endpoint
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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