|- candidate number||1353|
|- NTR Number||NTR188|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||8-sep-2005|
|- Secondary IDs||Ho44 |
|- Public Title||A randomized phase III study on the effect of the chimeric anti-CD20 monoclonal antibody (MabThera) during sequential chemotherapy followed by autologous stem cell transplantation in patients with relapsed or progressive B-cell non-Hodgkin’s lymphoma.|
|- Scientific Title||A randomized phase III study on the effect of the chimeric anti-CD20 monoclonal antibody (MabThera) during sequential chemotherapy followed by autologous stem cell transplantation in patients with relapsed or progressive B-cell non-Hodgkin’s lymphoma.|
|- ACRONYM||HOVON 44 NHL|
|- hypothesis||The hypothesis to be tested is that the outcome in arm B is better than in arm A.|
|- Healt Condition(s) or Problem(s) studied||Non Hodkin's lymfoma (NHL)|
|- Inclusion criteria||1. Malignant lymphoma based upon a representative histology specimen according to the REAL classification at relapse or progression: Follicular center lymphoma, follicular (grade III), Diffuse large B-cell lymphoma, Primary mediastinal B-cell lymphoma;|
2. CD20 positive;
3. First progression or relapse during/after adriamycin containing regimen. ‘Progressive’ includes patients who have progressive disease (PD, without prior response) and patients who have progression after first PR;
4. Age 18-65 years inclusive;
5. WHO performance status 0 - 1;
6. Witnessed written informed consent according to the center requirements.
|- Exclusion criteria||1. Patients with history of intolerance of exogenous protein administration;|
2. Patients with severe cardiac dysfunction (NYHA classification II-IV);
3. Patients with severe pulmonary dysfunction (vital capacity or diffusion capacity < 70% of predicted value) unless clearly related to NHL involvement;
4. Patients with hepatic dysfunction, bilirubin or transaminase >= 2.5 x upper normal limit;
5. Patients with renal dysfunction (serum creatinine >= 180 mmol/l or clearance <= 40 ml/min);
6. Prior treatment with immunotherapy or radiation therapy within the last month before entering the study;
7. Patients with active uncontrolled infections;
8. Patients known to be HIV-positive;
9. Patients with NHL localization in the central nervous system;
10. Patients with (EBV) post-transplant lymphoproliferative disorder.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||20-nov-2000|
|- planned closingdate||1-jan-2007|
|- Target number of participants||300|
|- Interventions||Patients will be randomized between:|
1. Arm A:
Cycle I: DHAP, Cycle II: VIM, in case of PR or CR Cycle III: DHAP or VIM, BEAM + autologous SCT;
2. Arm B:
Cycle I: DHAP + rituximab, Cycle II: VIM + rituximab, in case of PR or CR Cycle III: DHAP or VIM + rituximab, BEAM + autologous SCT.
|- Primary outcome||Overall survival measured from the date of registration. Patients still alive or lost to follow up are censored at the last day they were known to be alive.|
|- Secondary outcome||1. Response to DHAP-VIM with or without rituximab (MabTheraâ);|
2. Event-free survival (i.e. time from registration to the date of stable disease after both the first and second reinduction cycle, documented progression, relapse or death, whichever comes first).
|- Trial web site||http://www.hovon.nl|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. E. Vellenga|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. E. Vellenga|
|- Sponsor/Initiator ||VU University Medical Center, Dutch haemato-oncology association (Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)|
(Source(s) of Monetary or Material Support)
|Koningin Wilhelmina Fonds (KWF), Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)|
|- Brief summary||Study phase: phase III.|
evaluation of the effect of MabTheraâ with respect to response to reinduction treatment before autologous stem cell transplantation and overall survival and event free survival after autologous stem cell transplantation.
patients with CD20 positive NHL (FCLF III, DLBCL or PMBCL) in first relapse or progression, age 18-65 years inclusive.
prospective, multicenter, randomized.
Duration of treatment:
expected duration of treatment is about 3-4 months.
|- Main changes (audit trail)|
|- RECORD||1-sep-2005 - 19-okt-2009|