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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.


- candidate number1353
- NTR NumberNTR188
- ISRCTNISRCTN95614846
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR8-sep-2005
- Secondary IDsHo44 
- Public TitleA 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 TitleA 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.
- ACRONYMHOVON 44 NHL
- hypothesisThe hypothesis to be tested is that the outcome in arm B is better than in arm A.
- Healt Condition(s) or Problem(s) studiedNon Hodkin's lymfoma (NHL)
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 20-nov-2000
- planned closingdate1-jan-2007
- Target number of participants300
- InterventionsPatients 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 outcomeOverall 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 outcome1. 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).
- TimepointsN/A
- Trial web sitehttp://www.hovon.nl
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. E. Vellenga
- CONTACT for SCIENTIFIC QUERIESProf. Dr. E. Vellenga
- Sponsor/Initiator VU University Medical Center, Dutch haemato-oncology association (Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
- Funding
(Source(s) of Monetary or Material Support)
Koningin Wilhelmina Fonds (KWF), Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
- PublicationsN/A
- Brief summaryStudy phase: phase III.


Study objective:
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.


Patient population:
patients with CD20 positive NHL (FCLF III, DLBCL or PMBCL) in first relapse or progression, age 18-65 years inclusive.


Study design:
prospective, multicenter, randomized.


Duration of treatment:
expected duration of treatment is about 3-4 months.
- Main changes (audit trail)
- RECORD1-sep-2005 - 19-okt-2009


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