PACIFICO

• Research type

  Research Study

• Full title

  Purine-Alkylator Combination In Follicular lymphoma Immuno-Chemotherapy for Older patients: a phase III comparison of first-line R-CVP versus R-FC

• IRAS ID

  13686

• Eudract number

  2008-004759-31

• ISRCTN Number

  ISRCTN99217456

• Research summary

  This study is a two arm, open-label, multi-centre, parallel group, phase III, randomised controlled trial comparing rituximabfluarabine, cyclophosphamide(R-FC) and rituximab, cyclophosphamide, vincristine, prednisolone(R-CVP)in older patients with symptomatic advanced-stage follicular lymphoma. 680 patients will be randomised in total, 340 into each arm. The primary aim of the trial will be to compare two different induction regimens in order to determine which achieves the best balance between efficacy and toxicity. Patients will receive 24 weeks of treatment and responders will then go on to receive 2 years of rituximab maintenance. All patients will be followed up for a minimum of 3 years from trial entry.The schedule of treatment is as follows:Arm 1: R-CVP repeated every 21 days for 8 cyclesArm 2: R-FC repeated every 21 days for 4 cycles followed by rituximab alone for 4 further cycles.Rituximab maintenance: All responding patients will receive rituximab maintenance (2 monthly for 2 years).Quality of life and Health Economic questionnaires (EORTC QLQ C-30,EQ-5D,EQ-VAS) will be completed at the baseline, 2 weeks after the 4th and 8th cycles during induction therapy and every 4 months thereafter.The trial will support a wide range of laboratory studies aiming to elucidate novel biomarkers that predict therapeutic response or toxicity. To facilitate these studies, the following biosamples will be collected at baseline and stored centrally: a) Formalin fixed paraffin embedded (FFPE) lymph node biopsies b) Anti-coagulated blood c) Clotted blood for serum studiesIn addition, sequential anti-coagulated and clotted blood samples may be collected from selected patients for dynamic biomarker studies. Collecting these additional samples would not involve additional study visits or venesections. If additional samples are required procedures will be included as a protocol amendment

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  09/H1005/29

• Date of REC Opinion

  19 Jun 2009

• REC opinion

  Further Information Favourable Opinion