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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.


- candidate number5591
- NTR NumberNTR1757
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-apr-2009
- Secondary IDs2006-002141-37 EudraCT number
- Public TitlePhase 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 TitlePhase 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.
- ACRONYMHOVON 80 NHL
- hypothesisThe 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) studiedNon Hodkin's lymfoma (NHL), B-Cell lymphoma, Central Nervous System (CNS)
- Inclusion criteria1. 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 criteria1. 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 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 receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 3-okt-2006
- planned closingdate31-dec-2010
- Target number of participants35
- InterventionsThree cycles of R-DHAP + MTX and rituximab i.t., followed by ASCT.
- Primary outcomeProgression-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 outcome1. Response to R-DHAP-MTX;
2. Overall survival;
3. Toxicity;
4. Percentage of patients transplanted.
- TimepointsAt 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 sitewww.hovon.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. J.E.C. Bromberg
- CONTACT for SCIENTIFIC QUERIESDr. J.K. Doorduijn
- Sponsor/Initiator HOVON Data Center
- Funding
(Source(s) of Monetary or Material Support)
Koningin Wilhelmina Fonds (KWF), Roche Nederland BV, HOVON
- PublicationsN/A
- Brief summaryStudy 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.
- Main changes (audit trail)
- RECORD10-apr-2009 - 23-sep-2009


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