The primary objective of the study is the evaluation of sustained response rate after discontinuation of treatment with TPO-RAs, Eltrombopag and Romiplostim, in persistent or chronic pITP patients who failed one or more therapy lines, splenectomy included.
Increasing evidence exists in the literature on the persistent response after TPO-RAs discontinuation. However, the available data consist of description of case reports from different patients' series. At this time, systematic data collections on this topic do not exist and the real incidence of such persistent response is unknown. Therefore, because of the increasing interest in this new and challenging therapeutic field, also for the therapeutic implications, we would like to investigate the impact of TPO- RAs on the achievement of sustained and persistent responses after their discontinuation in the Italian adult patients affected by pITP who have been referred to the GIMEMA Centers.
Study Type
OBSERVATIONAL
Enrollment
148
Investigation of the impact of TPO-RAs on the achievement of sustained and persistent response after discontinuation in adult patients affected by pITP.
Investigation of the impact of TPO-RAs on the achievement of sustained and persistent response after discontinuation in adult patients affected by pITP.
S.O.C. di Medicina Interna B - Ospedale - Cardinal Massaia di Asti
Asti, Italy
Istituto di Ematologia "Lorenzo e A. Seragnoli"
Bologna, Italy
Unità di Onco-Ematologia - Azienda Ospedaliera - Garibaldi
Catania, Italy
Estimation of sustained response rate after discontinuation of treatment with TPO-RAs in terms of patients still alive in Complete Response or R at more than 4 weeks after discontinuation.
Time frame: One year from start of recruitment.
Frequency of the type of response in patients treated with TPO-RAs in absence of concomitant or rescue medication, in order to estimate the rate of Response (R) and Complete Response (CR).
Time frame: One year from start of recruitment.
Estimation of the suspension criteria in terms of frequency of discontinuation causes for each center.
Time frame: One year from start of recruitment.
Estimation of the duration of sustained response in terms of patients alive in CR or R at 6 and 12 months after sustained response achievement.
Time frame: One year from start of recruitment.
Estimation of incidence of relapse and loss of response at 6 and 12 months after sustained response achievement.
Time frame: One year from start of recruitment.
Estimation of treatment duration starting from the date of first dose of TPO-RAs.
Time frame: One year from start of recruitment.
Description of Platelet levels and TPO-RAs dosage at stop.
Time frame: One year from start of recruitment.
Description of patients' characteristics in term of: biological and clinical features, disease duration at the beginning of TPO-RAs, number and type of therapy lines preceding TPO-RAs treatment, platelet levels at TPO-RAs start.
Time frame: One year from start of recruitment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio Pad. 16 - 1° Piano
Florence, Italy
Clinica Medica III - Padiglione ex isolamento - Azienda Ospedale Università San Martino
Genova, Italy
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
Lecce, Italy
Azienda Ospedaliera "S.Gerardo"
Monza, Italy
Ematologia - Ospedale San Carlo
Potenza, Italy
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
Reggio Emilia, Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma, Italy
...and 3 more locations
Assessment of an association between previous splenectomy and sustained response after discontinuation of treatment with TPO-RAs.
Time frame: One year from start of recruitment.
Description of concomitant therapies since TPO-RAs start in terms of type and duration of therapies.
Time frame: One year from start of recruitment.