E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
nodal follicular non-Hodgkin´s Lymphoma (WHO Grade I/II) in clinical stage I/II |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029603 |
E.1.2 | Term | Non-Hodgkin's lymphoma stage II |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029602 |
E.1.2 | Term | Non-Hodgkin's lymphoma stage I |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
Efficacy of an involved-field radiotherapy combined with the CD20 antibody Rituximab in nodular follicular lymphoma (WHO grade 1/2) in limited stage (clinical stage I/II).
Main objective: progressive free survival after 2 years
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E.2.2 | Secondary objectives of the trial |
response after 7 weeks (total remission) response after 18 weeks (total remission) relapse free survival after 2 years toxicity according to Common Toxicity Criteria (CTC) overall survival after 2 and 5 years life quality (EORTC QLQ-C30)
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
The sub-study is integrated in the MIR-study protocol Version 1.1a; 1. Feb 2007.
1. Analysis of TP53 mutation in lymph nodes Objective: Incidence of TP53 mutations in follicular lymphoma in limited stage and estimation of its biological and prognostic impact.
2. Minimal rest disease (MRD) Objective: Detection of tumor cells at the beginning and during the therapy (MIR-study) via polymerase chain reaction (PCR) and evaluation of their prognostic capacity.
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E.3 | Principal inclusion criteria |
1. Histology: follicular lymphoma grade 1/2 according to WHO classification (2001); CD20 positivity 2. Manifestation: untreated nodal lymphoma (including: manifestation in Waldeyer´s ring) 3. Age: 18-75 4. ECOG: 0 - 2 5. Stage CS I and II (Ann Arbor classification) 6. tumor: equal or less than 7 cm diameter 7. signed informed consent of the study participant and compliance during the whole study duration 8. no simultaneous participation in another clinical study (until evaluation of the primary endpoint) 9. Leukozyten ≥ 3000 x 103 / ml, Thrombozyten ≥ 100000 x 10 3 / ml, Hämoglobin ≥ 10 g/dL 10. effective contraception for man and women during and further 12 month after the end of the treatment period.
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E.4 | Principal exclusion criteria |
1. ECOG > 2 2. follicular lymphoma grade 3 (also grade 3a) 3. Bulky disease: lymphoma > 7 cm diameter 4. Infestation of the spleen 5. Pretreatment: radiotherapy, chemotherapy or immunotheray 6. second neoplasia (excluded: basalioma, spinalioma) 7. Concomitant diseases: congenital or aquired immunodeficiency syndrome, collagen disease 8. severe psychiatric diseases 9. Pregnancy / Nursing 10. Known protein allergy 11. History of hypersensitivity to the investigational product or to any excipient present in the pharmaceutical form of the investigational product 12. Mental condition rendering the subject incapable to understand the rational, scope and possible consequences of the trial
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E.5 End points |
E.5.1 | Primary end point(s) |
progressive free survival after 2 years |
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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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | 17 |
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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4.5 years after first patient in (FPI).
Approximately: last quarter 2011/ first quarter 2012 |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |