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.
ID
Bron
Verkorte titel
Aandoening
Recurrent aggressive B-cell lymphoma with CNS localisation, DLBCL, non-hodgkin lymphoma, NHL
Ondersteuning
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
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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).
Onderzoeksproduct en/of interventie
Three cycles of R-DHAP + MTX and rituximab i.t., followed by ASCT.
Publiek
Afd. Neurologie
Postbus 5201
J.E.C. Bromberg
Rotterdam 3008 AE
The Netherlands
+31 (0)10 7041911
j.bromberg@erasmusmc.nl
Wetenschappelijk
Afd. Neurologie
Postbus 5201
J.E.C. Bromberg
Rotterdam 3008 AE
The Netherlands
+31 (0)10 7041911
j.bromberg@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL1659 |
NTR-old | NTR1757 |
Ander register | EudraCT number : 2006-002141-37 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |