No registrations found.
ID
Source
Brief title
Health condition
Recurrent aggressive B-cell lymphoma with CNS localisation, DLBCL, non-hodgkin lymphoma, NHL
Sponsors and support
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
Intervention
Outcome measures
Primary outcome
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 outcome
1. Response to R-DHAP-MTX;
2. Overall survival;
3. Toxicity;
4. Percentage of patients transplanted.
Background summary
Study phase:
Phase II
Study objective:
Evaluation of intensive therapy for relapsed B-cell lymphoma with CNS localisation.
Treatment includes:
A. Intrathecal administration of rituximab
B. Combining R-DHAP with high dose methotrexate intravenously.
The following endpoints will be evaluated:
Progression free survival, response rate and overall survival.
Patient population:
Patients with CD20 positive lymphoma (DLBCL, follicular lymphoma grade 3) in first relapse or progression, with central nervous system involvement with or without systemic disease, age 18-65 years inclusive.
Study design:
Prospective multicenter
Duration of treatment:
Expected duration of 5 months. All patients will be followed until 5 years after registration.
Study objective
The hypothesis to be tested is that treatment with three courses of R-DHAP + MTX combined with rituximab i.t., followed by ASCT is feasible and that the efficacy meets the expectations as described in the protocol.
Study design
At entry, after cycle 2, after cycle 3, after Tx, after RT (if applicable), in FU every 3 months during first 2 years, every 6 months during the next 2 years and annually thereafter (until total of 5 years).
Intervention
Three cycles of R-DHAP + MTX and rituximab i.t., followed by ASCT.
Afd. Neurologie
Postbus 5201
J.E.C. Bromberg
Rotterdam 3008 AE
The Netherlands
+31 (0)10 7041911
j.bromberg@erasmusmc.nl
Afd. Neurologie
Postbus 5201
J.E.C. Bromberg
Rotterdam 3008 AE
The Netherlands
+31 (0)10 7041911
j.bromberg@erasmusmc.nl
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
1. History of intolerance of exogenous protein administration;
2. Severe cardiac dysfunction (NYHA classification III-IV, or LVEF < 45%);
3. Severe pulmonary dysfunction (vital capacity or diffusion capacity < 50% of predicted value) unless clearly related to NHL involvement;
4. Hepatic dysfunction, bilirubin or transaminase ¡Ý 2.5 x upper normal limit, unless related to lymphoma;
5. Renal dysfunction (serum creatinine >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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1659 |
| NTR-old | NTR1757 |
| Other | EudraCT number : 2006-002141-37 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |