EUCTR2006-002141-37-NL
Active, not recruiting
Not Applicable
Phase II study on the feasibility and efficacy of R-DHAP + HD-MTX, combined with intrathecal rituximab, followed by autologous stem cell transplantation in patients with a recurrent aggressive B-cell lymphoma with CNS localisation - HOVON 80 NH
HOVON foundation0 sites35 target enrollmentJuly 5, 2006
Conditionsrelapsed B cell lymphomaMedDRA version: 8.1Level: LLTClassification code 10029547Term: Non-Hodgkin's lymphoma
DrugsMabthera
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- relapsed B cell lymphoma
- Sponsor
- HOVON foundation
- Enrollment
- 35
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\*Diagnosis of aggressive malignant B\-cell lymphoma based upon a representative histology specimen according to the WHO classification (see appendix A):
- •\-Follicular lymphoma grade III
- •\-Diffuse large B\-cell lymphoma
- •Prior low\-grade” lymphoma with histologically proven transformation to follicular lymphoma grade III or DLBCL is also permitted.
- •\*CD 20 positive
- •\*First progression or relapse with CNS localisation (see below) without or with systemic relapse (preferably histologically proven). ‘Progressive’ includes patients who have progressive disease (PD), without prior response and patients who have progression after first PR.
- •\*Diagnosis of CNS localisation based on at least one of the following:
- •\-Unequivocal morphological and/or immunophenotypical evidence of CSF lymphoma
- •\-clinical AND MRI evidence of leptomeningeal localisation
- •\-brain parenchymal lesion showing homogeneous contrast enhancement suspect for lymphoma, concurrently with systemic progression or recurrence
Exclusion Criteria
- •\*History of intolerance of exogenous protein administration
- •\*Severe cardiac dysfunction (NYHA classification III\-IV, appendix G, or LVEF \< 45%)
- •\*Severe pulmonary dysfunction (vital capacity or diffusion capacity \< 50% of predicted value) unless clearly related to NHL involvement
- •\*Hepatic dysfunction, bilirubin or transaminase \= 2\.5 x upper normal limit, unless related to lymphoma.
- •\*Renal dysfunction (serum creatinine \=150 umol/l or clearance \= 60 ml/min)
- •\*Prior cranial radiotherapy
- •\*Active uncontrolled infection
- •\*Known HIV\-positivity
- •\*(EBV) post\-transplant lymphoproliferative disorder
- •\*Documented CNS involvement during 1st line therapy (MTX intrathecal profylaxis during 1st line therapy is no exclusion criterium)
Outcomes
Primary Outcomes
Not specified
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