|- candidate number||5591|
|- NTR Number||NTR1757|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-apr-2009|
|- Secondary IDs||2006-002141-37 EudraCT number |
|- Public Title||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. |
|- Scientific Title||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. |
|- ACRONYM||HOVON 80 NHL|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Non Hodkin's lymfoma (NHL), B-Cell lymphoma, Central Nervous System (CNS)|
|- 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).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||3-okt-2006|
|- planned closingdate||31-dec-2010|
|- Target number of participants||35|
|- Interventions||Three cycles of R-DHAP + MTX and rituximab i.t., followed by ASCT.|
|- 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;
4. Percentage of patients transplanted.
|- Timepoints||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).|
|- Trial web site||www.hovon.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. J.E.C. Bromberg|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.K. Doorduijn|
|- Sponsor/Initiator ||HOVON Data Center|
(Source(s) of Monetary or Material Support)
|Koningin Wilhelmina Fonds (KWF), Roche Nederland BV, HOVON|
|- Brief summary||Study phase:|
Evaluation of intensive therapy for relapsed B-cell lymphoma with CNS localisation.
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.
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.
Duration of treatment:
Expected duration of 5 months. All patients will be followed until 5 years after registration.
|- Main changes (audit trail)|
|- RECORD||10-apr-2009 - 23-sep-2009|