E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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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 | HLGT |
E.1.2 | Classification code | 10025320 |
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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 | 10025319 |
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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 assess the 3 years event free survival of lymphoma patients submitted to BeEAM chemotherapy followed by the reinfusion of autologous hematopoietic stem cells. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal exclusion criteria |
HIV infection. Secondary lymphoma following prior chemotherapy/ radiotherapy or an active second malignancy. Pregnancy or nursing Absence of patients written informed consent Current uncontrolled infections Intercurrent organ damage or medical problems that would interfere with therapy |
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E.5 End points |
E.5.1 | 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. |
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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 | Yes |
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 | Yes |
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 | 5 |
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
|
Ultima visita dell`ultimo paziente dei 3 anni previsti di follow-up |
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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 | 5 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |