E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Untreated grade 1 and 2 Follicular Lymphoma |
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MedDRA Classification |
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 |
The main objective of this study is to evaluate the Progression Free Survival (PFS) in Lymphoma patients who receive CVP + Inteferon a-2b + Rituximab as first line treatment |
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints in this study are to evaluate: - objective Response Rates - Overall Survival (OS) and Overall Specific Survival (OSS) - Molecular remission and follow-up of Minimal Residual Disease (MRD). - Safety and Tolerability of the combination
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Age ≥18 and ≤ 75 years. - Grade 1 or 2 Follicular Lymphoma, Marginal Zone Lymphoma or Lymphocitic Lymphoma (with no CLL criteria) confirmed by nodal tissue. Patients with diagnosis made in bone marrow trephine will be accepted, if no adenopathy is detected and MCL or CLL are ruled out. - Follicular Lymphoma International Prognostic Index (FLIPI) ≥ 2. - No prior chemotherapy of radiotherapy. Local radiation is accepted. - Adequate hepatic and renal function (acceted if related to LNH infiltration) - Correct Thyroid function - ECOG performance status 0 to 3. - Abscence of other malignancies or impariment to receive thge drugs in the study. - Signed approved informed consent before any study specific procedures are performed.
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E.4 | Principal exclusion criteria |
- Prior chemotherapy of radiotherapy. - Active second malignancy in the previous 5 years. - Previous Psiquiatric disease, specially moderate to severe depression, psycosis, autolytic attempts. - Uncontrolled current cardiopathy (myocardial infarction, angina, significant cardiac arrythmia or congestive heart failure) - Diabetes mellitus insulin requirement. - Uncontrolled hepatic or autoimmune disease. - Female subjects who are breast-feeding - Female subjects, who are not surgically sterile or post-menopausal, and do not use medically acceptable methods of birth control for the duration of the study and for one year after the last dose. - Acute or ongoing chronic infectious disease. - Immunocopromised subjects including subjects known to be HIV possitive or acute/chronic HCV or HBV positive.
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E.5 End points |
E.5.1 | Primary end point(s) |
The main end point of this study is to evaluate the Progression Free Survival (PFS) in Lymphoma patients who receive CVP + Inteferon a-2b + Rituximab as first line treatment. |
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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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
resultados se compararán con los obtenidos de un estudio previo realizado con CVP+IFN |
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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 | Yes |
E.8.2.3.1 | Comparator description |
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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.8.5 | 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 | Information not present in EudraCT |
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 | |
E.8.9.1 | In the Member State concerned months | 79 |
E.8.9.1 | In the Member State concerned days | |