E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
RESISTANT FOLLICULAR NON HODGKIN LYNPHOMA |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059433 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
: 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 |
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E.2.2 | Secondary objectives of the trial |
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; |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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: <9 gr/dL; WBC: <3 x 10e9/L; absolute neutrophil count <1.5 x 10e9/L; platelets: <100 x10e9/L (unless cytopenia is secondary to bone marrow involvement of lymphoma). • Clinically significant cardiac disease. (NYHA Class III or IV) • Evidence of CNS involvement. • Abnormal liver function tests, not disease related, within 1 week prior to start of study above any of the values listed: serum bilirubin >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 |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |