chemotherapy-induced thrombocytopenia in patients affected by non-Hodgkin lymphoma MedDRA version: 14.1 Level: PT Classification code 10029547 Term: Non-Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: NPLATE*FL 250MCG POLV+SOLV
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: ROMIPLOSTIM
CAS Number: 267639-76-9
Concentration unit: µg microgram(s)
Sponsors
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patient with NHL of any histotype, both at diagnosis or at relapse, who experienced grade 4 CIT after the first course of chemotherapy containing high doses of meth-otrexate, cytarabine, cisplatin, cyclo-phosphamide and/or ifosfamide, and/or conven-tional doses of anthracyclines or purine analogs (permitted regimens: CHOP, CHOP-like, FC, FND, DHAP, ICE, IEV, MIV, MTX/araC), with or without rituximab. The same type of chemotherapy where the grade 4 CIT occurred will be continued at the same planned doses for a maximum of 8 courses. -Age =18 years. -ECOG performance status score ? 3. -Signed informed consent. -Adequate bone marrow function (ANC >1.000; Hb >9,5 g/dL; PLT > 75.000). 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 4 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: -Patients eligible for high-dose chemotherapy, where stem cell sup-port is planned. -Thrombotic events in the previous 5 years before enrolment. -Other malignancies diagnosed in the previous 5 years before enrolment. -Severe concomitant illnesses / medical conditions (e.g. impaired respiratory and/or car-diac function, uncontrolled diabetes mellitus). -Active infectious disease. -Impaired liver function (bilirubin >2 x upper normal limit; ALT/AST/GGT > 3 x upper normal limit) at one month from salvage chemotherapy conclusion. -Impaired renal function (creatinine clearance <50 ml/min) at one month from salvage chemotherapy conclusion. -Non-co-operative behavior or non-compliance. -Psychiatric diseases or conditions that might impair the ability to give informed con-sent. -Pregnant or lactating females (Females subjects of childbearing potential must comply with effective contraception during experimental treatment). -Previous therapy with any TPO-mimetic or similar substances. -Previous therapy supported by transplant of autologous or allogeneic stem cells.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate safety of Romiplostim in patients with newly diagnosed or relapsed NHL who experienced grade-4 chemotherapy-induced thrombocytopenia (CIT) after the first chemotherapy course.;Secondary Objective: To evaluate romiplostim activity by assessing the reduction of grade 4 CIT, CIT duration, number of platelets transfusions, with the possibil-ity to maintain the relative dose intensity of the chemotherapy regimen.;Primary end point(s): Romiplostim safety, defined by the incidence of grade > or equal 4 adverse events (NCI CTCAE v. 4.02 Dec 2009) during experimental treatment.;Timepoint(s) of evaluation of this end point: after second chemotherapy cycle till the end of chemotherapy treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Romiplostim activity defined by the incidence of grade 4 CIT (? 25 x 109/L) per chemo-therapy course during experimental treatment. -Recovery time from the first day of platelets count =25.000 plt/µL to the achievement of a platelet count of >25.000 plt/µL, summarized by each course. -Number of platelet transfusions per chemotherapy course, per patient, from the enrol-ment to end of chemotherapy. -Number of bleeding events per chemotherapy course, per patient, from the enrolment to end of chemotherapy.;Timepoint(s) of evaluation of this end point: after second chemotherapy cycle till the end of chemotherapy treatment | — |
Countries
Italy
Contacts
Public ContactDipartimento di Oncoematologia
FONDAZIONE SAN RAFFAELE DEL MONTE TABOR
Outcome results
None listed