E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
B-cell non-Hodgkin lymphomas |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10025320 |
E.1.2 | Term | Lymphomas non-Hodgkin's B-cell |
|
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 |
Progression-free survival at one year |
|
E.2.2 | Secondary objectives of the trial |
Overall survival Engraftment Incidence of acute graft-versus-host disease (aGVHD) Incidence of chronic graft-versus-host disease (cGVHD) Nonrelapse mortality at one year Percentage of molecular remissions at one year for patient having a molecular marker |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age ≥ 18 ≤ 65 years 2. Histologies as follow: 2a.Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) relapsing after at least 2 lines of conventional chemotherapy or relapsing after a first line (within one year) including purine analogue-based regimen or relapsing after autologous stem cell transplantation (as first or second line) 2b. Primary refractory CLL or SLL 2c.Follicular lymphomas (FCL) relapsing after 2 lines or relapsing after autologous stem cell transplantation 2d.Primary refractory FCL 2e.Mantle cell lymphomas (MCL) relapsing after conventional chemotherapy or autologous stem cell transplantation 2f.Diffuse large B-cell lymphomas (DLBCL) or transformed FCL relapsing after two lines of conventional chemotherapy or autologous stem cell transplantation 2g.CLL, FCL, MCL and DLBCL considered eligible for high-dose chemotherapy, with a positive bone marrow biopsy or collecting PCR positive harvests before the autografting phase 3. PS (Karnofsky)  70% 4. HLA-identical (A, B, C, DR, DQ loci) or one antigen mismatched (class I) sibling donors 5. Written informed consent |
|
E.4 | Principal exclusion criteria |
1. Central nervous system localization 2. Positive serologic markers for human immunodeficiency virus (HIV) 3. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection 4. Serum bilirubin levels > 2 the upper normal limit 5. Ejection fraction < 45% (or myocardial stroke in the last year) 6. Clearance of creatinine < 50 ml/min 7. DLCO < 50% 8. Pregnancy or lactation 9. Patient not agreeing to take adequate contraceptive measures during the study 10. Psychiatric disease 11. Any active, uncontrolled infection 12. Type I hypersensivity or anaphylactic reactions to rituximab |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Progression free survival |
|
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 | No |
E.6.4 | Safety | No |
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 | 26 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |