RESISTANT FOLLICULAR NON HODGKIN LYNPHOMA MedDRA version: 9.1 Level: LLT Classification code 10059433
Conditions
Interventions
Trade Name: Bendamustine Hydrochloride
Pharmaceutical Form: Powder for solution for injection
CAS Number: 16506-27-7
Current Sponsor code: SDX-105
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
A.I.L. (ASSOCIAZIONE ITALIANA CONTRO LE LEUCEMIE, LINFOMI E MIELOMI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female adult with Follicular Non Hodgkin lymphoma, relapsed or resistant after first line treatment with chemoimmunotherapy. • ECOG performance status 0-3; • Age = 60 years to 70 years . • Patient should be able and willing to comply with study visits and procedures per protocol • Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed 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: • Previous treatment with fludarabina. • Previous extensive radiotherapy • Patients that have received any investigational medicinal agent within four weeks prior to study entry • Contraindication to any of the study drugs • Hb: 2 mg/dL (35 mmol/L); ALAT or ASAT >2.5 N; alkaline phosphatase >2.5 N • Abnormal renal function (serum creatinine > 2.0 mg/dL not disease related). • Patients with active infections. • HIV, HbsAg positives (HbcAb positive patients and normal levels of hepatic enzymes can be enrolled, but must be monthly monitored for HBsAg and HBV-DNA and they will be placed under Lamivudina prophylaxis after PBSCs collection .) • Men of reproductive potential not agreeing to use acceptable methods of birth control during treatment and for six months after the completion of treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: : To evaluate safety of an intensified program including Bendamustine and high dose therapy and autograft for patients with Follicular Non Hodgkin Lymphoma at first relapse or resistant;Secondary Objective: To evaluate ability of Bendamustine to mobilize peripheral blood stem cell; 2) To describe the benefit-risk profile of R-oxali-DHA and R-bendamustine in inducing a clinical response (CR or PR) in patients with Follicular Lymphoma (FL) in first relapse or resistant to previous chemotherapy to plan an adequately designed and sized clinical trial. 3) To evaluate molecular remission before and post treatment with bendamustine and after transplant 4) to evaluate length of telomere before and post treatment with bendamustine; 5 ) To evaluate feasibility of an intensified program of salvage therapy in outpatient setting before autograft;;Primary end point(s): Safety Assessments: Safety will be recorded, assessed and analysed using adverse events, clinical laboratory results, vital signs, physical examinations, electrocardiograms recorded on the standard Case Report From (CRF) pages and serious adverse event (SAE) data form | — |
Countries
Italy
Outcome results
None listed