Recurrent aggressive B-cell lymphoma with CNS localisation, DLBCL, non-hodgkin lymphoma, NHL
Conditions
Interventions
Three cycles of R-DHAP + MTX and rituximab i.t., followed by ASCT.
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 7041560
Fax: 010 7041028
e-mail: hdc@erasmusmc.nl
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of aggressive malignant B-cell lymphoma based upon a representative histology specimen according to the WHO classification: A. Follicular lymphoma grade III; B. Diffuse large B-cell lymphoma; C. Prior 'low-grade' lymphoma with histologically proven transformation to follicular lymphoma grade III or DLBCL is also permitted. 2. CD 20 positive; 3. 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; 4. Diagnosis of CNS localisation based on at least one of the following: A. Unequivocal morphological and/or immunophenotypical evidence of CSF lymphoma; B. Clinical AND MRI evidence of leptomeningeal localisation; C. Brain parenchymal lesion showing homogeneous contrast enhancement suspect for lymphoma, concurrently with systemic progression or recurrence; D Biopsy-proven brain parenchymal NHL localisation of previously diagnosed systemic NHL. 5. Age 18-65 years inclusive; 6. WHO performance status 0 ¨C 2 with or without administration of steroids; 7. Written informed consent according to the centre's requirements; 8. Negative pregnancy test in women of reproductive potential.
Exclusion criteria
Exclusion criteria: 1. History of intolerance of exogenous protein administration; 2. Severe cardiac dysfunction (NYHA classification III-IV, or LVEF 150 umol/l or clearance < 60 ml/min); 6. Prior cranial radiotherapy; 7. Active uncontrolled infection; 8. Known HIV-positivity; 9. (EBV) post-transplant lymphoproliferative disorder. Documented CNS involvement during 1st line therapy (MTX intrathecal profylaxis during 1st line therapy is no exclusion criterium).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free 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 R-DHAP-MTX; 2. Overall survival; 3. Toxicity; 4. Percentage of patients transplanted. | — |
Contacts
Public ContactJ.E.C. Bromberg
Erasmus MC - Daniel den Hoed Afd. Neurologie Postbus 5201
Outcome results
None listed