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Trial Details
Trial status:
Closed
Recruitment start date:
06/07/2006
Funder:
Sponsor:
LYSA
Chief Investigator:
Professor Andrew Lister
Recruitment target:
1200
EudraCT number:
2004-001756-36
Contact details:
ctc.bnli@ucl.acuk
Lay summary:
PRIMA
A multicentre, phase III, open-label, randomized study in patients with advanced follicular lymphoma evaluating the benefit of maintenance therapy with Rituximab (MabThera®) after induction of response with chemotherapy plus Rituximab in comparison with no maintenance therapy
Description
Design: PRIMA is an open label, international, multicentre, randomiszed study with two treatment phases.  During the first phase, patients will be evaluated for response to different induction regimens.  In the second phase patients responding to induction treatment will be randomiszed to maintenance therapy versus no further treatment (observation).
Treatment: Patients will be registered and will receive one of 3 regimens (CVP + Rituximab x 8 cycles), (CHOP x 6 cycles + Rituximab x 8 cycles) or (FCM x 6 cycles + Rituximab x 8 cycles) decided by the site in advance.  Patients that achieve a CR, Cru or PR are then randomised to either a further 12 cycles of Rituximab or Observation.  Patients on both arms will be seen every 8 weeks for 24 months.  Patients are then followed up for 5 years.
Key inclusion/exclusion criteria: Patients must be 18 or above and have histologically proven follicular lymphoma grade 1, 2 or 3a.  Patients must have at least one of the following: Bulky disease, B symptoms, Elevated serum LDH or b2 microglobulin, involvement of at least 3 nodal sites, symptomatic splenic enlargement, compressive syndrome or pleural/peritoneal effusion.  Patients can’t have CNS disease or poor renal or hepatic function.  Patients can’t have prior or concomitant malignancies except for non-melanoma skin cancer of adequately treated in situ cervical cancer.
Duration of recruitment: 2 years
Aim
The aim of this trial is to evaluate the benefit of maintenance therapy with rituximab as measured by progression-free survival (PFS) in comparison with no maintenance therapy after induction of response with chemotherapy plus rituximab in patients with high tumour burden follicular lymphoma
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
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Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
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