Thrombotic Thrombocytopenic Purpura, AcquiredDarTTPNCT07513948
Daratumumab in Immune-mediated Thrombotic Thrombocytopenic Purpura
An observational study of Thrombotic Thrombocytopenic Purpura, Acquired, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Thrombotic Thrombocytopenic Purpura, Acquired
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2025to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- patients unwilling or unable to provide their informed consent;
- follow-up < 6 months after daratumumab administration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Angelo Bianchi Bonomi Hemophilia and Thrombosis Center
Milan
Juri A Giannotta, M.D., +390255035273, juri.giannotta@policlinico.mi.it
Juri A Giannotta, M.D.
About this study
Official title: DarTTP: an Observational, International, Multicentric Study on Daratumumab in Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)
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.
Read the detailed description
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.
- Keywords
- daratumumab, thrombotic thrombocytopenic purpura, ADAMTS13
- Medical subject headings
- Thrombotic thrombocytopenic purpura, acquired, Purpura, Thrombotic Thrombocytopenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with iTTP | Patients with a confirmed diagnosis of iTTP, aged ≥ 18 years, treated with daratumumab for iTTP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of responders to daratumumab
Number of patients responding to daratumumab / total number of patients treated with daratumumab (response defined as the achievement of ADAMTS13 activity levels above 20% of normal at any timepoint from the first daratumumab administration to 12 weeks after the last dose, without new additional immunosuppressants)
Measured: From the first daratumumab administration to 12 weeks after the last dose
Secondary outcomes (2)
Safety of daratumumab
Number of adverse events related to daratumumab, using CTCAE v5.0
Measured: From the first daratumumab administration to 24 weeks after
Duration of response
Median ADAMTS13 relapse-free survival after daratumumab treatment
Measured: From the date of the first documented ADAMTS13 activity >20% after the first dose of daratumumab until the date of ADAMTS13 relapse (i.e., ADAMTS13 activity <20%), assessed up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Oct 2025
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombotic Thrombocytopenic Purpura, AcquiredStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513948
- Sponsor's protocol ID
- 6442
- Acronym
- DarTTP
- Status last verified
- Nov 2025
- First submitted
- 19 Jan 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DarTTP: an Observational, International, Multicentric Study on Daratumumab in Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)
- ClinicalTrials.gov ID
- NCT07513948
- Acronym / sponsor ID
- DarTTP / 6442
- Keywords
- daratumumab, thrombotic thrombocytopenic purpura, ADAMTS13
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with iTTP | – | –Patients with a confirmed diagnosis of iTTP, aged ≥ 18 years, treated with daratumumab for iTTP |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- patients unwilling or unable to provide their informed consent;
- follow-up < 6 months after daratumumab administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of responders to daratumumab
Time frame: From the first daratumumab administration to 12 weeks after the last dose
Number of patients responding to daratumumab / total number of patients treated with daratumumab (response defined as the achievement of ADAMTS13 activity levels above 20% of normal at any timepoint from the first daratumumab administration to 12 weeks after the last dose, without new additional immunosuppressants)
2 secondary outcomes
Safety of daratumumab
Time frame: From the first daratumumab administration to 24 weeks after
Duration of response
Time frame: From the date of the first documented ADAMTS13 activity >20% after the first dose of daratumumab until the date of ADAMTS13 relapse (i.e., ADAMTS13 activity <20%), assessed up to 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombotic Thrombocytopenic Purpura, Acquired, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juri A Giannotta, M.D. (+390255035273, juri.giannotta@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of responders to daratumumab (time frame: From the first daratumumab administration to 12 weeks after the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.