patients affected by linphoproliferative pathologies MedDRA version: 9.1 Level: SOC Classification code 10005329 Term: Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: NEULASTA*6MG 1SIR 0,6ML SC
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Pegfilgrastim
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
OSPEDALE S. RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with lymphoid malignancies (diffuse large cell lymphoma-DLCL, Hodgkin lymphoma, chronic lymphocytic leukemia-CLL, multiple myeloma-MM or other lymphoid malignancies indicated for autologo transplantation). 2. Target graft size (unmanipulated) - peripheral blood: 4 - 10 x 106 CD34+ cells/kg BW recipient 3. Age > 18 and 80 % 5. Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Secondary malignancies 2. Severe concomitant illnesses / medical conditions (e.g. impaired respiratory and/or cardiac function) 3. Active infectious disease 4. HIV- positivity or active hepatitis infection 5. Impaired liver function (Bilirubin > upper normal limit; Transaminases > 3.0 x upper normal limit) 6. Impaired renal function (Creatinine-clearance 1.5 x upper normal limit). 7. Pleural effusion or ascites > 1.0 L 8. Pregnancy or lactation 9. Known hypersensitivity to Pegfilfrastim 10. Participation in another experimental drug trial within 4 weeks before day -6 11. Non-co-operative behaviour or non-compliance 12. Psychiatric diseases or conditions that might impair the ability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluation of mortality due to febrile neutropenia; evaluation of incidence of febrile neutropenia; percentage of readmissions to the hospital due to febrile neutropenia;Secondary Objective: number of days with neutrophils below 500/mcl;Primary end point(s): a. mortality due to febrile neutropenia b. incidence of febrile neutropenia; c. percentage of readmissions to the hospital due to febrile neutropenia; | — |
Countries
Italy
Outcome results
None listed