Trial Information
Multicenter Study to Evaluate the Combination of Oral Fludarabine, Mitoxantrone Und Rituximab Induction Therapy Und Rituximab Maintenance Therapy in Follicular B-Cell Lymphoma
Inclusion Criteria:
- a positive BCL2/IgH rearrangement in peripheral blood (PB) and/or bone marrow (BM)
- clinical stage III or IV, requiring treatment with one or more of the following
criteria: symptoms related to the disease, hemoglobin less than 12 g/dL, platelets
less than 100 G/L, progressive disease, bulky tumor of more than 10 cm
Exclusion Criteria:
- pretreatment
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment
Outcome Measure:
conversion rate of bcl-2 in blood and bone marrow defined by PCR
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Michael Fridirk, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
AKH Linz
Authority:
Austria: Federal Office for Safety in Health Care
Study ID:
AGMT_NHL 9
NCT ID:
NCT01560117
Start Date:
January 2004
Completion Date:
July 2010
Related Keywords:
- Follicular T-NHL Lymphoma
- Rituximab Maintenance
- AGMT
- NHL
- Lymphoma
- Lymphoma, B-Cell