Studies for high grade Non-Hodgkin's lymphoma (NHL)
Highly professional scientific planning, implementation and evaluation of the trial is the requirement for reliable study results.
The German Non-Hodgkin's Lymphoma Study Group (DSHNHL) was founded in 1993 and has since conducted national and international trials in first line and salvage therapies. During the course of the first generation, a prospective, randomized phase III trial (NHL-B1/B2) with 1697 patients, the therapeutic effect of dose intensity (shortening time intervals from 3 to 2 weeks) and the addition of etoposide to standard CHOP therapy was investigated.
The study results of the NHL-B1/B2 trial ended many years of therapeutic stagnation, setting new standards and leading to a real improvement of treatment in the field.
The results were published by Pfreundschuh et al in the journal BLOOD (Volume 104, Number 3).
In preparation for second generation studies, the DSHNHL investigated three phase I/II studies to evaluate different chemotherapy modalities.
In 2000, based on the experience gained from the first generation trials, the second generation studies began with 4 prospective, randomized, phase III trials in different risk groups. One such study is the International MInT trial in which 172 centers from 18 countries took part. This International clinical trial demonstrated therapeutic improvement for young, low risk patients following administration of the Rituximab monoclonal antibody.
Since the establishment of the DSHNHL, the number of participating centers and patients has increased, approximately by a rate of 800 patients per year with over 200 participating centers.
The IMISE works in close co-operation with its clinical partners on the development of trial design, protocol redaction, trial management as well as the evaluation and publication of trial results.
Leader of the Project Group
- Open Trials:
- High/ CHOEP (Phase III)
- MEGA/ CHOEP
- CHOP/ CHOEP - Campath
- CHOEP (R eskaliert)
- Closed trials:
- NHL B1/ B2
- CIVEP (B2)
- NHL - A2
- High/ CHOEP (Phase II)
- NHL - R1
- NHL - R2
- MInT (german)
DSHNHL supportive projects
- Evaluation of prognostic factors for tumour response (german)
- Evaluation of prognostic factors for therapy side effects (german)
- Investigations into the pathology and immune histochemistry of aggressive NHL (german)
- Investigations into the health economical aspects of the NHL-B study (german)
- Development of working instructions
- Development of NHL study databases
- Participation in the quality management working group of the malignant lymphoma competence network