Therapie des nodalen Follikulären Non-Hodgkin-Lymphoms (WHO Grad I/II) im klinischen Stadium I / II mittels involved-field Bestrahlung in Kombination mit Rituximab (Mabthera Involved-field Radiotherapy-Trial/ MIR)english translation:Therapy of the nodal follicular non-Hodgkin´s Lymphoma (WHO Grade I/II) in clinical stage I/II with involved field radiatherapy in combination with Rituximab (Mabthera Involved-field Radiotherapy-Trial/ MIR) - MIR

Phase 1

• Conditions: nodal follicular non-Hodgkin´s Lymphoma (WHO Grade I/II) in clinical stage I/II; MedDRA version: 14.1Level: PTClassification code 10029603Term: Non-Hodgkin's lymphoma stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10029602Term: Non-Hodgkin's lymphoma stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2006-001212-72-DE
• Lead Sponsor: niversity Hospital of Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-09
• Study Completion: 2013-04-10
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 85

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified