Diagnosis of Non-Hodgkin lymphoma of any subtype, chronic lymphocytic leukemia, or Hodgkin disease either refractory or relapsed after at least one line of chemotherapy. MedDRA version: 9.1 Level: HLGT Classification code 10025320 MedDRA version: 9.1 Level: HLGT Classification code 10025319
Conditions
Interventions
Trade Name: RIBOMUSTIN
Pharmaceutical Form: Powder and solvent for solution for infusion
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 160-
Sponsors
AZIENDA OSPEDALIERA OSPEDALE S. SALVATORE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of Non-Hodgkin lymphoma of any subtype, chronic lymphocytic leukemia, or Hodgkin disease either refractory or relapsed after at least one line of chemotherapy. Age ≥ 18 and ≤ 65 years. Signed Informed Consent. Karnofsky score > 70% or WHO ≤ 1. Adequate hematologic, renal, pulmonary and hepatic function. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: HIV infection. Secondary lymphoma following prior chemotherapy/ radiotherapy or an active second malignancy. Pregnancy or nursing Absence of patient?s written informed consent Current uncontrolled infections Intercurrent organ damage or medical problems that would interfere with therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the 3 years event free survival of lymphoma patients submitted to BeEAM chemotherapy followed by the reinfusion of autologous hematopoietic stem cells.;Secondary Objective: To assess the safety of BeEAM chemotherapy followed by the reinfusion of autologous hematopoietic stem cells by considering the incidence of adverse event (graded according to WHO) and clinically significant abnormal laboratory values following reinfusion. To assess the percentage of patients entering complete remission (CR). To assess the overall survival of resistant or relapsed lymphoma patients exposed to BeEAM chemotherapy followed by the reinfusion of autologous hematopoietic stem cells as salvage treatment. To assess transplant-related toxicity.;Primary end point(s): To assess the 3 years event free survival of lymphoma patients submitted to BeEAM chemotherapy followed by the reinfusion of autologous hematopoietic stem cells. | — |
Countries
Italy
Outcome results
None listed