nodal follicular non-Hodgkin´s Lymphoma (WHO Grade I/II) in clinical stage I/II MedDRA version: 14.1 Level: PT Classification code 10029603 Term: Non-Hodgkin's lymphoma stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10029602 Term: Non-Hodgkin's lymphoma stage I System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: MabThera
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
CAS Number: 174722-31-7
Current Sponsor code: MabThera
Other descriptive name: RITUXIMAB
Sponsors
University Hospital of Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 ;Secondary Objective: 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) ;Primary end point(s): progressive free survival after 2 years | — |
Countries
Germany
Outcome results
None listed