Protocols of DSHNHL
first line therapy
DSHNHL 2004-1 (CHOP-R-ESC)
2-weekly CHOP with dose-dense RITUXIMAB for the treatment of patients aged 61-80 years with aggressive CD20-positive diffuse large B-cell Lymphomas.
A phase II / pharmacokinetic study.
DSHNHL 2004-2 (FLYER)
A randomised study for comparison of immunotherapy with 6 cycles of the monoclonal anti-CD20-antibody Rituximab in combination with 6 or 4 cycles of chemotherapy with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) in intervals of 21 days for the treatment of patients with aggressive CD20-positive B-cell lymphoma, aged 18-60 years, without risk factors (age adjusted IPI=0) and without bulk involvement (tumor diameter <7,5 cm).
DSHNHL 2004-3 (UNFOLDER)
A randomised study for comparison of combined immunotherapy with 6 cycles of the monoclonal anti-CD20-antibody Rituximab in combination with 6 cycles of chemotherapy with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) in intervals of 21 or 14 days with or without consolidating radiotherapy of bulk involvement and/or extranodal involvements for the treatment of patients with aggressive CD20-positive B-cell-lymphoma, aged 18-60 years, with age adjusted IPI=1 (all) or IPI=0 with bulk involvement (tumor diameter >=7.5 cm).
DSHNHL 2003-1 (CHOP-Campath)
Prospective phase II study for treatment of peripheral T-cell-lymphoma with CHOP-14 + PEG-filgrastim followed by Alemtuzumab-consolidation
DSHNHL 2002-1 (Mega-CHOEP Phase III)
Prospective, randomised, open phase III study for comparison of conventional chemotherapy (CHOEP-14) with repetitive high-dose therapy followed by autologous stem cell transplantation (Mega-CHOEP) with or without administration of Rituximab for the treatment of patients with first diagnosis of aggressive non-Hodgkin-lymphoma in special risk situation, aged 18-60 years
DSHNHL 2006-1B (ACT-2)
A randomized phase III study to evaluate the efficacy of chemoimmunotherapy with the monoclonal antibody Campath-1H (Alemtuzumab) given in combination with 2-weekly CHOP versus 2-weekly CHOP alone in elderly patients with previously untreated systemic peripheral T-cell lymphomas
DSHNHL 2006-1A (AATT)
Autologous or allogeneic transplantation following conventional chemotherapy in younger patients (18-60 yrs.) with mature (peripheral) T-cell lymphoma (Acronym: AATT)
The aim is to investigate whether the event-free survival of patients with primary diagnosis of mature (peripheral) T-cell lymphoma can be improved by allogeneic hematopoietic stem cell transplantation after conditioning with FBC compared to autologous peripheral blood stem cell transplantation after high dose therapy with BEAM. Conventional treatment before high dose therapy will be the same for both treatment arms (4 cycles of CHOEP-14 followed by one cycle of DHAP).
Salvage therapy
DSHNHL 2003-R3 (allo-hNHL (FluBuCy))
Open, multicentric, randomised phase II study:
Allogeneic stem cell transplantation after pre treatment with fludarabine, busulfan, cyclophosphamide and GVHD-prophylaxis with or without Rituximab in patients with relapse of aggressive non-Hodgkin-lymphoma in special risk situation, aged 18-65 years
Protocol for DSHNHL 2003-R3 (1.7 MB, German)DSHNHL 2004-R4 (esc Z-BEAM)
Open, multicentric, non-randomised phase II study:
Dose escalation of Zevalin and immediate application of high-dose chemotherapy with BEAM followed by autologous stem cell transplantation for treatment of refractory and relapsed aggressive non-Hodgkin-lymphoma
Observational studies
DSHNHL 1999-1A (RICOVER-60)
Randomised study for comparison of 6 and 8 cycles of chemotherapy with CHOP (cyclophosphamide, doxorubicine, vincristine and prednisone) in intervals of 14 days (CHOP-14) each with or without monoclonal CD-20-antibody Rituximab in patients with aggressive non-Hodgkin-lymphoma, aged 61-80 years(with amendment)
» Documents for DSHNHL 1999-1A
!! Attention: This study has been closed for randomisation !!
CD20 positive patients will be assigned to arm 6x CHOP-14 + 8x Rituximab!
Patients with T-NHL or CD20 negative B-NHL will be assigned to arm 6x CHOP-14!
If you have further question please contact central office of DSHNHL in Homburg
closed studies
DSHNHL 2003-2 (Pegfilgrastim / Neulasta)
Randomised phase II study to evaluate the administration of pegfilgrastim (Neulasta) on day 2 or day 4 for the treatment of patients with aggressive non-Hodgkin-lymphoma aged 61-80 years with 6 or 8 cycles of chemotherapy with CHOP (cyclophosphamide, doxorubicine, vincristine and prednisone) in intervals of 14 days each with or without the monoclonal CD20-antibody Rituximab.
!! The Neulasta study has been closed on 8th of July 2005 with achievement of planned patient numbers !!
If you have further questions please contact central office DSHNHL in Homburg
DSHNHL 1999-2 (High/CHOEP-21-Study)
Randomised study for comparison of chemotherapy with CHOEP (cyclophosphamide, doxorubicine, vincristine, etoposide and prednisone) in intervals of 21 days with standard and escalated dose for treatment of patients with aggressive non-Hodgkin-lymphoma aged 18-60 years and good prognosis (IPI-score 0,1)
MabThera International Trial (MinT)
Intergroup study of first line treatment of patients with diffuse large B-cell non-Hodgkin lymphoma with chemotherapy regimen similar to CHOP with or without anti-CD20-antibody Rituximab (IDEC-C2B8)
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