Daratumumab for acquired immune thrombotic thrombocytopenic purpura
DarTTP: an Observational, International, Multicentric Study on Daratumumab in Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)
This project tests whether daratumumab can raise ADAMTS13 activity in adults with acquired (immune) TTP who did not respond to or could not tolerate standard immunosuppressive treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Drugs / interventions | daratumumab, Rituximab |
| Locations | 1 site (Milan) |
| Trial ID | NCT07513948 on ClinicalTrials.gov |
What this trial studies
This is an observational, collaborative effort to collect real-world data on daratumumab use in patients with acquired immune TTP who are refractory or intolerant to standard immunosuppression. Investigators will gather clinical and laboratory outcomes, including safety data, from multiple centers and report the proportion of patients achieving ADAMTS13 activity above 20% at six months after first daratumumab administration. The protocol includes adults with confirmed immune TTP (ADAMTS13 activity less than 10% with anti-ADAMTS13 antibodies) who have been treated with daratumumab and have at least six months of follow-up. Existing evidence is limited to case reports, so this larger collection aims to clarify efficacy and tolerability in a broader group.
Who should consider this trial
Good fit: Adults (age ≥18) with confirmed immune-mediated TTP (ADAMTS13 activity <10% with anti-ADAMTS13 antibodies) who have received daratumumab for iTTP and have at least six months of follow-up are the ideal candidates for inclusion.
Not a fit: Patients with non-immune forms of TTP, those who respond adequately to standard therapies, or those unable to receive daratumumab are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, daratumumab could provide an effective treatment option to restore ADAMTS13 activity and reduce relapses in patients with refractory or intolerant iTTP.
How similar studies have performed: Only isolated case reports and small series have reported favorable outcomes with daratumumab in refractory iTTP, and no large systematic datasets have been published to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milan
- Angelo Bianchi Bonomi Hemophilia and Thrombosis Center — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Juri A Giannotta, M.D.
- Email: juri.giannotta@policlinico.mi.it
- Phone: +390255035273
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.