Main info

Identificatie:

HOVON 44 NHL

Sponsor:

HOVON

Included patients:

239

Active sites:

25

(of 25)

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.

Timeline

Flow

Details

Phase:

Prospective randomized Phase III study

Monitoring Type:

Objectives:

Eligibility

Inclusion Criteria:

• 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
• CD20 positive
• 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
• Age 18-65 years inclusive
• WHO performance status 0 - 1 (see appendix E)
• Witnessed written informed consent according to the center requirements

Exclusion Criteria:

• Patients with history of intolerance of exogenous protein administration
• Patients with severe cardiac dysfunction (NYHA classification II-IV, appendix F)
• Patients with severe pulmonary dysfunction (vital capacity or diffusion capacity < 70% of predicted value) unless clearly related to NHL involvement
• Patients with hepatic dysfunction, bilirubin or transaminase >= 2.5 x upper normal limit
• Patients with renal dysfunction (serum creatinine >=180 mumol/l or clearance <=40 ml/min)
• Prior treatment with immunotherapy or radiation therapy within the last month before entering the study
• Patients with active uncontrolled infections
• Patients known to be HIV-positive
• Patients with NHL localization in the central nervous system
• Patients with (EBV) post-transplant lymphoproliferative disorder

Participating Sites

= Active hospitals

= Inactive hospitals