Non Hodgkin’s Lymphoma
Conditions
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.
Sponsors
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 4391568
Fax: 010 4391028
e-mail: hdc@erasmusmc.nl
Eligibility
Inclusion criteria
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
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 = 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Contacts
Public ContactE. Vellenga
University Medical Center Groningen (UMCG), Department of Hematology, P.O. Box 30001
Outcome results
None listed