Immune ThrombocytoPenia (ITP) secondary to Chronic Lymphoproliferative Disorders (LPDs) MedDRA version: 15.0 Level: PT Classification code 10050245 Term: Autoimmune thrombocytopenia System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: REVOLADE*28CPR RIV 25MG
Pharmaceutical Form: Coated tablet
INN or Proposed INN: ELTROMBOPAG OLAMINE
CAS Number: 496775-62-3
Concentration unit: mg milligram(s)
Concentration type: up to
Co
Sponsors
FONDAZIONE PROGETTO EMATOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosis of any of the following B-cell chronic LPD, as defined by WHO 2008 classification: small lymphocytic lymphoma/chronic lymphocytic leukemia, follicular lymphoma, marginal zone lymphoma, mantle cell lymphoma, lymphoplasmacytic lymphoma, hairy cell leukemia, Hodgkin’s lymphoma. 2) Occurrence of ITP diagnosed on the basis of predefined criteria. 3) Not likely to necessitate any cytotoxic treatment for the following 6 months, according to clinical stage and performance status. 4) Platelet count less than 30,000/µL; patients with platelet count between 30 and 50,000/µL only in case of bleeding signs or symptoms. 5) Age greater than or equal to 18 years. 6) Absence of a personal or family (up to first degree relatives) history of venous or arterial thromboembolism. 7) ECOG performance status =2. 8) Adequate liver and renal function. 9) Absence of active Hepatitis B (HBsAg+ or HBV-DNA+), Hepatitis C (HCV-Ab+), or HIV infection. 9) Provided informed consent. 10) Negative pregnancy test or lactation 11) No antiplatelet or anticoagulant ongoing treatments Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 13 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
Exclusion criteria: 1) Subjects with any clinically relevant abnormality, other than LPD or ITP, or any other medicalcondition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study. 2) Subjects with any concurrent malignant disease other that the LPD and/or a recent history of cancer treatment with systemic chemotherapy and/or radiotherapy. Exception: Subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. 3) Subjects with screening bone marrow fibers of either MF Grade 3 using European Consensus scale or Grade 4 using Bauermeister scale (see Appendix 1). 4) Subjects with a QTc >450 msec or > 480 msec for subjects with Bundle Branch Block. 5) Subjects with recent history of alcohol/drug abuse as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Proportion of responders to eltrombopag as defined by changes in the platelet count, in platelet transfusion requirements and/or in the bleeding symptoms during the 6 months of treatment.;Secondary Objective: Assessment of the safety profile of eltrombopag in patients with LPD using the CTCAE criteria.;Primary end point(s): Proportion of responders to eltrombopag as defined by changes in the platelet count, in platelet transfusion requirements and/or in the bleeding symptoms during the 6 months of treatment.;Timepoint(s) of evaluation of this end point: during the 6 months of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Assessment of the safety profile of eltrombopag in patients with LPD using the CTCAE criteria.;Timepoint(s) of evaluation of this end point: for the duration of the study | — |
Countries
Italy
Contacts
Public ContactEmatologia
ULSS 6 Vicenza
Outcome results
None listed