DarTTP: an Observational, International, Multicentric Study on Daratumumab in Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)
Conditions: Thrombotic Thrombocytopenic Purpura, Acquired
Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Dipartimento Area Medica
SC Medicina – Emostasi e Trombosi                       - Direttore: Prof.ssa Flora Peyvandi
Tel. 02 5503.5422
E-mail: emostasietrombosi@policlinico.mi.it
 “Daratumumab in immune-mediated thrombotic thrombocytopenic purpura
(iTTP)”
Acronym: DarTTP
Promoter: Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, 
Via Sforza 28, 20122 Milano, Italia
Coordinating Center: SC Medicina - Emostasi e Trombosi – Centro Emofilia e 
Trombosi “Angelo Bianchi Bonomi”
Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, 
Via Pace 9, 20122 Milano, Italia
Principal Investigator: Juri Alessandro Giannotta
               
 __________________________________________
Type of document: non-interventional study 
Version: v.1.0
Date: 16/07/2025
CONFIDENTIALITY STATEMENT 
All information presented in this document will be considered confidential and will remain the exclusive property of
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico. The use of such confidential information must be
limited to the recipient for the agreed purpose and must not be disclosed, published or otherwise communicated to
unauthorized persons, for any reason, in any form without the prior written consent of Fondazione IRCCS Ca' Granda
Ospedale Maggiore Policlinico.
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TABLE OF CONTENTS
1. Title page
2. Abbreviations
3. Study responsibilities and collaborations
4. Abstract
5. Protocol amendments
6. Timelines 
7. Background
8. Aim of the study
9. Methods
9.1.  Study design
9.1.1. Primary endpoint
9.1.2. Secondary endpoints
9.2.  Setting
9.2.1. Study population: 
9.2.2. Inclusion criteria
9.2.3. Exclusion criteria
9.2.4. Study drug administration and schedule
9.2.5. Planned visits and evaluations
9.3. Variables
9.4. Source document
9.5. Sample size 
9.6. Data management
9.7. Data analysis
9.8. Quality control 
9.9. Study limitations
10.  Protection of patients included in the study
10.1.
Subject information note and consent form for the processing of personal data
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10.2.
Insurance coverage
11. Management and notification of adverse events/reactions
11.1 Definitions of adverse event and adverse reaction
12. Study results dissemination
13. Publication and intellectual property rights of the study results  
14. Funding
15. References
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2. Abbreviations 
iTTP: immune-mediated thrombotic thrombocytopenic purpura
ADAMTS13: a disintegrin and metalloproteinase with a thrombospondin type 1 motif member 13
CTCAE: Common Terminology Criteria for Adverse Events
REDCap: Research Electronic Data Capture
IRCCS: Istituto  di Ricerca  e Cura a Carattere  Scientifico  (Scientific  Institute  for Research,
Hospitalization and Health Care)
3. Study responsibilities and collaborations
The study promoter is the Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico of Milan.
The principal investigator (PI) is Dr. Juri Alessandro Giannotta of Medicina – Emostasi e Trombosi
Complex Structure of Fondazione. Dr. Giannotta will be responsible for the dissemination of the
results of the study. He will coordinate the data analysis of patients recruited at other Italian and
foreign collaborating centers.
The local working group is composed by: 
-Andrea Artoni (patients’ enrollment), 
-Addolorata Truma (patients’ enrollment), 
-Syna Miri (creation of the electronic Case Report Form), 
-Ilaria Mancini (data analysis). 
4. Abstract
Title: “DarTTP: an observational, international, multicentric study on daratumumab in immune-
mediated thrombotic thrombocytopenic purpura (iTTP)” – v.1.0, 16-JUL-2025 – Juri Alessandro
Giannotta (PI) - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Angelo Bianchi
Bonomi Hemophilia and Thrombosis Center, Milan, Italy
Backgroud and rationale: 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
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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. Bortezomib allows an ADAMTS13 response in 60-70% of rituximab-
refractory iTTP patients, although adverse events (particularly, neurotoxicity) are reported in 15-
50% of cases. In the last two years, the less toxic anti-CD38 monoclonal antibody daratumumab has
been employed in selected iTTP patients with good results. However, evidence stems only from
isolated case reports and a French nation-wide study including 9 patients.
Aim of the study: 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: international, multicentric, non-interventional, retrospective observational study.
Study population: adult iTTP patients treated with daratumumab in the acute or remission phase of
disease.
Variables: patient’s demographics, date of iTTP diagnosis, immunosuppressive treatments before
daratumumab,  comorbidities,  ADAMTS13  activity  and  anti-ADAMTS13  antibody  titer  at
daratumumab  treatment  and  during  follow-up,  immunoglobulin  A,  G  and  M  levels  before
daratumumab treatment and 3-6 months after, date of daratumumab infusions, date of clinical and
ADAMTS13 remission, daratumumab-related adverse events (specifying grade), dates of clinical
and/or ADAMTS13 relapses after daratumumab treatment.
Source document: medical records.
Sample size: 40 patients (minimum 16 for the calculation of the sample size).
Data analysis: Data were expressed as counts and percentages, indicating medians and interquartile
range (IQR). The duration of ADAMTS13 remission after daratumumab treatment was expressed as
ADAMTS13 relapse-free survival, estimated by the Kaplan–Meier analysis. 
Timelines: 
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Start of data collection: OCT-2025
End of data collection: JAN-2026
Final report: APR-2026
5. Protocol amendments
Not applicable.
6. Timelines
Step of the study
Planned date
Start of the study and data collection
OCT-2025
End of the study and data collection
JAN-2026
Final report of the study
APR-2026
7. Background 
Immune-mediated TTP (iTTP) in an autoimmune disease caused by autoantibodies directed against
ADAMTS13. The current standard of treatment, including plasma exchanges, steroids +/- rituximab,
and caplacizumab, warrants a significant reduction of mortality to less than 5% [1-3]. Moreover, pre-
emptive treatment with rituximab during clinical remission in case of ADAMTS13 relapse (i.e., a
decline in ADAMTS13 activity levels below 20% [4]) is recommended by the International TTP
guidelines to prevent clinical iTTP relapse [3]. However, 10-15% of patients do not achieve a
sustained ADAMTS13 remission with rituximab after the acute phase or when rituximab is used pre-
emptively [5, 6]. Additionally, about half of rituximab-responsive patients eventually need re-
treatment after 12 months or less, and long-term safety of frequent rituximab cycles are still
unknown in iTTP [6, 7]. For this selected category of patients, therapeutic options are scarce, and
rely on old immunosuppressive agents (e.g., cyclosporine, azathioprine, mycophenolate mofetil,
cyclophosphamide, vincristine) or splenectomy, all burdened by relevant toxicity and lack of solid
efficacy data [8, 9].
Recently, targeting CD20-negative long-lived plasma cells appears to be a promising strategy in
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refractory  iTTP.  Anti-proteasome  bortezomib  allows  an  ADAMTS13  response  in  60-70%  of
rituximab- and often multi-refractory iTTP patients [10, 11], although adverse events (particularly,
neurotoxicity) are reported in 15-50% of cases. Considering the generally young age of iTTP
patients, the toxicity mitigation along with the achievement of ADAMTS13 remission represents a
clinically significant composite outcome. In the last two years, the less toxic monoclonal antibody
daratumumab, targeting CD38-positive plasma cells, has been employed in selected iTTP patients
with good results. However, evidence stems only from isolated case reports [12-15] and a French
nation-wide study including 9 patients [16].
8. Aim of the study
This study aims to collect retrospective evidence on a larger number of iTTP patients treated with
daratumumab because of refractoriness or intolerance to other immunosuppressive drugs. In detail,
the primary objective of the study is to evaluate the efficacy of daratumumab in iTTP patients. 
The secondary objectives are:
- efficacy of daratumumab in patients treated for refractory iTTP;
- efficacy of daratumumab in iTTP patients who were responding to other immunosuppressive
therapies but experienced adverse reactions, leading to a change in therapeutic strategy;
- safety of daratumumab;
- time to response to daratumumab;
- duration of response to daratumumab;
- frequency of clinical relapses following daratumumab treatment.
9. Methods
9.1 Study design
No profit, multicentric, pharmacological, observational, retrospective, cohort study.
9.1.1 Primary endpoint
- Proportion of responders to daratumumab (i.e., number of patients responding to daratumumab /
total number of patients treated with daratumumab); response is defined as the achievement of
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ADAMTS13  activity  levels  above  20% of normal  at  6  months  from the  first  daratumumab
administration, without new additional immunosuppressants.
9.1.2. Secondary endpoints
- Proportion of patients achieving ADAMTS13 complete (> lower limit of the normal, LLN, range
of ADAMTS13 activity test used) or partial (>20% of normal) remission, if daratumumab used in
refractory patients (i.e., while ADAMTS13 activity is <20% of normal);
- proportion of patients maintaining ADAMTS13 complete or partial remission, if daratumumab
used in patients  responding to the ongoing immune suppressive treatment  (i.e., ADAMTS13
activity >20%) but experiencing adverse reactions (including unsatisfactory duration of response to
rituximab) leading the clinician to change the therapeutic strategy;
- number of adverse events related to daratumumab, using CTCAE v5.0;
- median time to ADAMTS13 partial and complete remission after daratumumab treatment;
- median duration of ADAMTS13 remission after daratumumab treatment;
- proportion of patients experiencing clinical relapses after daratumumab treatment.
9.2 Setting 
The study includes both inpatients and outpatients treated with daratumumab for iTTP from January
2010 to 6 months before the time of data collection. The medical records will be used as source
documents. The estimated time for enrollment is four months. 
9.2.1 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. 
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9.2.2 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.
9.2.3 Exclusion criteria
- patients unwilling or unable to provide their informed consent;
- follow-up < 6 months after daratumumab administration.
9.2.4 Study drug administration and schedule 
Daratumumab is a human anti-CD38 monoclonal antibody of the IgG1κ isotype, produced in a
mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology. The
recommended dose of daratumumab is 16 mg/kg of body weight administered as an intravenous
infusion or 1800 mg administered as a subcutaneous infusion. Daratumumab is not licensed for the
treatment of iTTP, therefore clinicians used it at variable schedules and doses as per physician’s
choice and based on published available evidence in iTTP [11-15].
9.2.5 Planned visits and evaluations 
No additional visits/evaluations are requested than those planned as per current clinical practice. 
9.3 Variables
a) iTTP history before daratumumab administration
- patient’s date of birth
- date of iTTP diagnosis (defined as non-immune microangiopathic anemia and thrombocytopenia
with severe ADAMTS13 activity deficiency in presence of anti-ADAMTS13 autoantibodies)
- ADAMTS13 activity and anti-ADAMTS13 antibody titer at diagnosis
- immunosuppressive treatments used before daratumumab 
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- dates of clinical and/or ADAMTS13 relapses
b) Variables at daratumumab treatment
- patient’s weight and height
- tobacco use
- comorbidities, with date of diagnosis
- setting of daratumumab treatment (acute phase of disease or remission phase); if acute phase, date
of TTP event and treatments (start and stop date of plasma exchanges and/or caplacizumab)
- ADAMTS13 activity and anti-ADAMTS13 antibody titer at daratumumab treatment and during
follow-up
- immunoglobulin A, G and M levels before daratumumab treatment and 3-6 months after
- immunosuppressive treatments ongoing at daratumumab treatment
- date of daratumumab infusions
- ancillary drugs used as premedication and/or anti-infective prophylaxis
- date of clinical and ADAMTS13 remission 
- daratumumab-related adverse events, specifying grade (according to CTCAE v.5.0 criteria)
- dates of clinical and/or ADAMTS13 relapses after daratumumab treatment, with respective
treatments employed
9.4 Source document
All data will be obtained from clinical records collected at the enrolling centers.
9.5 Sample size
This is a descriptive, single-arm study designed to explore the efficacy of daratumumab in a
subpopulation of patients with iTTP, a rare and life-threatening autoimmune condition. Due to the
rarity of the disease, all patients  who meet the inclusion criteria and are followed up at the
participating  centers  during the study period will  be enrolled,  with no formal upper limit  to
recruitment.
Given this context, the aim of the study is not only exploratory but also intended to consolidate and
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support the existing evidence in the literature, which suggests that daratumumab is effective in
approximately 89% of treated patients in achieving and maintaining a clinically relevant increase in
ADAMTS13 activity [16].
Assuming an actual treatment efficacy of 89%, and comparing it to the historical reference value of
48% observed with conventional immunosuppressive agents such as azathioprine [9], a formal
power analysis indicated that a minimum of 16 patients would be required to statistically confirm the
treatment  effect.  This  target  is  considered  feasible  within  the  framework  of  this  multicenter
collaboration on a rare disease.
The sample size was calculated using a one-sided exact binomial test, performed in G*Power
version 3.1.9.7, with the following settings:
- Test family: Exact
- Statistical test: Proportions: Inequality, one sample, binomial
- Tail(s): One (right-tailed)
- Null proportion: 0.48 (assumed as the minimum clinically relevant response threshold, based on
our previous data in iTTP patients treated with azathioprine)
- Proportion under the alternative hypothesis: 0.89 (treatment efficacy of daratumumab according to
existing literature)
- Alpha error probability: 0.05 (one-sided)
- Power (1 – β): 0.80
9.6 Data management
At enrollment, each participant will be assigned a unique code. Data de-identification will be
performed in such a way that individuals accessing the database will not be able to trace the identity
of the subjects in any manner. Only local investigators will have access to the identities of the
enrolled subjects. The data necessary for the study will be recorded in a dedicated electronic Case
Report  Form  (eCRF)  within  a  Data  Management  System  validated  according  to  national
regulations, provided by the Scientific Directorate of the Foundation. The platform used will be
REDCap (Research Electronic Data Capture). The REDCap Consortium consists of over 1,000
institutional partners worldwide (research institutions, universities, ministries, etc.). The consortium
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supports a secure web application (REDCap) designed exclusively to facilitate data acquisition for
research studies. The REDCap application allows users to create and manage online databases
quickly and securely, and is currently in use for more than 110,000 projects with approximately
150,000 users covering numerous research interest areas across the consortium. Through REDCap,
the following measures will be implemented for this study: a) user-level identification with specific
restrictions based on role in the study, b) real-time data validation and integrity checks, c) patient
de-identification prior to data export, d) centralized data storage with daily backups on a secure
server within the Foundation's IT infrastructure.
9.7 Data analysis
Data were expressed as counts and percentages, indicating medians and interquartile range (IQR).
The  duration  of  ADAMTS13  remission  after  daratumumab  treatment  was  expressed  as
ADAMTS13 relapse-free survival, estimated by the Kaplan–Meier analysis. 
9.8 Quality control 
To ensure adequate quality control of the study, the investigator will allow, upon request, direct
access to all relevant documentation and will dedicate part of their time to discuss the study results.
Additionally, Regulatory Authorities may conduct inspections. In this case, the investigator must
grant the inspector direct access to all pertinent documentation and allocate part of their time and
staff to the inspector to discuss the monitoring results and any other aspects of the study. The
presence of two operators is required for all manual data entries to prevent potential errors.
9.9 Study limitations
There are some limitations for this study: 
- its retrospective nature, with an enrollment period spanning presumably >3 years and including
different treatment schedules of daratumumab and variable ADAMTS13 testing timepoints after
daratumumab administration in different enrolling Centers;
- the small sample size, limited by the rarity of iTTP;
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-  a  possible  underestimation  of  the  prevalence  of  adverse  events,  since  they  were  captured
retrospectively neither in a standardized way nor at standard timepoints. 
10. Protection of patients included in the study
The study will be conducted in accordance with Good Clinical Practice guidelines, the ethical
principles  derived  from  the  Declaration  of  Helsinki,  and  the  current  regulations  regarding
observational studies. The observational study and its related documentation will be submitted to
the appropriate Ethics Committee. The study will commence only after receiving the necessary
approvals according to the internal procedures of the institution. The Ethics Committee must also
approve any modifications to the protocol and the advertising used to recruit subjects for the study,
in accordance with local regulations.
10.1 
 
 Subject information note and consent form for the processing of personal data 
 
 
It is the responsibility of the physicians to obtain consent to the information note through the
privacy consent form with date and signature from each patient before the start of data collection.
The signature attests to the understanding of the consents and the information contained therein. In
addition, the investigator must sign and date the informed consent form. The signed documents
must be archived by the investigator, while a copy must be given to the patient. 
Given the nature of Scientific Institute for Research, Hospitalization and Health Care (IRCCS) of
the Policlinico, promoter of the study, in compliance with the current legislation on the protection
of personal data (EU Reg. 679/2016) and Legislative Decree 196/2003 (Privacy Code) as amended
by Legislative Decree 101/2018, for the data collected and processed by the Promoter and other
participating centers having the nature of IRCCS, it will not be mandatory to ask the participants in
the study for consent to the use of their personal data for the conduct of the study itself. In
compliance with the provisions of art. 110 bis paragraph IV of the amended Legislative Decree
196/2003, due to the instrumental nature that the healthcare activity assumes with respect to
research at IRCCS, the processing for research purposes of personal data already collected for
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clinical activity, including the anonymization of the same, does not in fact constitute further
processing. 
As stipulated by the Data Protection Authority, the aforementioned provision applies to all
types of medical research (both prospective and retrospective) promoted by IRCCS, including
multicentric studies involving entities without the same institutional status.
Therefore, the abovementioned legal basis also extends to all other participating centers in
the study that do not hold the status of IRCCS.
The IRCCS, as the Study Sponsor, will be responsible for drafting a Data Protection Impact
Assessment to be published on its official website and for notifying the Data Protection
Authority accordingly.
10.2 Insurance coverage
Given the observational nature of the present study, no additional insurance policies are necessary
other than those already provided for normal clinical practice.
11. Management and notification of adverse events/reactions
All adverse events occurring during the treatment and throughout the study observation
period  have  been  reported  in  accordance  with  the  applicable  post-marketing
pharmacovigilance  regulations.  Any  adverse  events  that  have  occurred  will  also  be
documented in the study Case Report Form (CRF).
11.1 
 
 Definitions of adverse event and adverse reaction
 
 
Adverse event: any unwanted medical event that occurs in a patient included in a clinical trial to
whom a medicinal product is administered and that does not necessarily have a causal relationship
with the treatment. 
Adverse reaction: harmful and unwanted effect resulting from the use of a medicinal product,
including  effects  resulting from therapeutic  error, abuse, misuse, off-label use, overdose and
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professional exposure. The reaction, unlike the event, presupposes at least a reasonable possibility
of correlation between the effect and the administered drug. 
A serious adverse reaction is defined as one that:
- endangers the patient's life
- requires hospitalization of the patient or prolongs a hospitalization that has already occurred
- causes persistent or significant disability or incapacity 
- causes death
- involves a congenital anomaly or birth defect.
12. Study results dissemination 
The principal investigator will write a final report for the dissemination of the results at the end of
the study. Data will be made public anonymously and presented as requested in aggregate form.
13. Publication and intellectual property rights of the study results  
Publications
The Foundation, as Promoter, will guarantee the dissemination and publication of the study results,
even in the event of negative results, without any constraints and guaranteeing the collaborating
Centers visibility proportional to the actual participation. Each scientific journal or publication
containing the results and data of the study must indicate the role and participation of the Centers
and the Foundation, in a manner proportional to the actual contribution made to the study and the
role  covered  by  each  party.  The  data  will  be  published  in  aggregate  form  or  in  any  case
anonymized, so as not to allow in any way the identification of the interested party to whom the
data refers.
Intellectual property rights 
The Parties acknowledge that for the conduct of the collaboration within the scope of the study,
data, information, know-how, inventions (patentable or not) owned by each party may be used and
shared, which remains the exclusive owner even if it grants the other a right of access and use, non-
exclusive and free of charge, for the sole purpose of carrying out the activities covered by the study
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and limited to the duration of the study. It is understood that this right of use does not include the
right to sublicense to third parties. In accordance with current legislation, the data and results
generated within the scope of the Study will be owned by the Promoter, except for specific
agreements between the Promoter and the Centers.
14.Funding
None.
15. References
1.
Scully M, McDonald V, Cavenagh J, Hunt BJ, Longair I, Cohen H, et al. A phase 2 study of
the  safety  and  efficacy  of  rituximab  with  plasma  exchange  in  acute  acquired  thrombotic
thrombocytopenic purpura. Blood. 2011;118(7):1746-53.
2.
Scully M, Cataland  SR, Peyvandi F, Coppo P, Knöbl P, Kremer Hovinga JA, et al.
Caplacizumab Treatment for Acquired Thrombotic Thrombocytopenic Purpura. N Engl J Med.
2019; 380(4):335-46.
3.
Zheng XL, Vesely SK, Cataland SR, Coppo P, Geldziler B, Iorio A, et al. ISTH guidelines
for treatment of thrombotic thrombocytopenic purpura. J Thromb Haemost. 2020; 18: 2496-502.
4.
Cuker A, Cataland SR, Coppo P, de la Rubia J, Friedman KD, George JN, et al. Redefining
outcomes  in  immune  TTP:  an  international  working  group  consensus  report.  Blood.  2021;
137(14):1855-61. 
5.
Hie M, Gay J, Galicier L, et al. Preemptive rituximab infusions after remission efficiently
prevent  relapses  in acquired  thrombotic  thrombocytopenic  purpura:  experience  of the  French
Thrombotic Microangiopathies Reference Center. Blood; 2014; 124(2):204–10. 
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6.
Coppo P, Cuker A, George JN. Thrombotic thrombocytopenic purpura: Toward targeted
therapy and precision medicine. Res Pract Thromb Haemost. 2018; 3(1):26-37. 
7.
Tieu J, Smith RM, Gopaluni S, Kumararatne DS, McClure M, Manson A, et al. Rituximab
Associated Hypogammaglobulinemia in Autoimmune Disease. Front Immunol. 2021; 12: 671503.
8.
Westwood JP, Scully M. Management of acquired, immune thrombocytopenic purpura
(iTTP): beyond the acute phase. Ther Adv Hematol. 2022; 13:20406207221112217.
9. Bichard C, Mancini I, Agosti P, Capecchi M, De Leo P, Arcudi S, et al. Efficacy and safety of
azathioprine during remission of immune-mediated thrombotic thrombocytopenic purpura. Blood
Adv. 2022; 6:5463-5466.
10. Lee NCJ, Yates S, Rambally S, Sarode R, Ibrahim IF, Shen YM, et al. Bortezomib in
relapsed/refractory immune thrombotic thrombocytopenic purpura: A single-centre retrospective
cohort and systematic literature review. Br J Haematol. 2024; 204: 638-43. 
11. Giannotta JA, Artoni A, Mancini I, Agosti P, Carpenedo M, Truma A, Miri S, Ferrari B, De Leo
P, Salutari P, Mancini G, Molteni A, Rinaldi E, Bocchia M, Napolitano M, Prezioso L, Cuccaro A,
Scarpa E, Condorelli A, Grimaldi D, Massaia M, Peyvandi F. Bortezomib for rituximab-refractory
immune-mediated  thrombotic  thrombocytopenic  purpura  in  the  caplacizumab  era:  an  Italian
multicenter study. J Thromb Haemost. 2024; S1538-7836(24)00686-X.
12. van den Berg J, Kremer Hovinga JA, Pfleger C, Hegemann I, Stehle G, Holbro A, et al.
Daratumumab for immune thrombotic thrombocytopenic purpura. Blood Adv. 2022; 6: 993-7. 
13. Aggarwal A, White D, Pavord S, Thomas W, Desborough MJR. Daratumumab for refractory
immune-mediated thrombotic thrombocytopenic purpura. Br J Haematol. 2023; 202: 429-33. 
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14. Xie XT, Xiao YY, Zhang Y, Luo ZM, Luo Y. Combination regimens containing daratumumab
for initial diagnosed acquired thrombotic thrombocytopenic purpura. J Thromb Thrombolysis.
2023; 55: 399-405.
15. Jansen  AJG, Rab  MAE,  Te  Boekhorst  PAW,  Leebeek  FWG. Successful  treatment  with
daratumumab for splenectomy refractory immune-mediated thrombotic thrombocytopenic purpura.
Br J Haematol. 2024 Oct 20. doi: 10.1111/bjh.19856. Epub ahead of print. 
16. Weisinger J, Bouzid R, Ranta D, Woaye-Hune P, Cohen-Aubart F, Gaible C, Marjanovic Z,
Corre  E,  Joly  AC,  Baylatry  MT,  Joly  BS,  Veyradier  A,  Coppo  P.  Efficacy  and  safety  of
daratumumab  in  multiresistant  immune-mediated  thrombotic  thrombocytopenic  purpura.  Br  J
Haematol. 2024 Nov;205(5):1951-1958. 
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