Daratumumab in Immune-mediated Thrombotic Thrombocytopenic Purpura
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
patients unwilling or unable to provide their informed consent;
follow-up < 6 months after daratumumab administration.
Trial 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.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 1 trial groupGroup A: Adult patients with iTTP
Trial outcomes
Primary outcomes
1
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)
Time frame
From the first daratumumab administration to 12 weeks after the last doseSecondary outcomes
1
Safety of daratumumab
Number of adverse events related to daratumumab, using CTCAE v5.0
Time frame
From the first daratumumab administration to 24 weeks after2
Duration of response
Median ADAMTS13 relapse-free survival after daratumumab treatment
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.Sponsors and contacts
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Source ClinicalTrials.gov