Dr Gordon Cook (Chair)

In March 2000 approval was given by the BSBMT Executive committee to establish a clinical trials committee (CTC). The remit of the CTC was to support clinical studies in stem cell transplantation (SCT) in the UK/Eire, to advise on the role of SCT incorporated into disease-specific studies, to assist in local study developments by accessing the BSBMT Database and to provide advice and statistical support in the planning and executing of studies. Furthermore, the CTC would aim to provide a useful link between purchaser and provider of SCT services through an active role in supporting the appropriateness of SCT. Central to these aims are the establishment of personnel with key roles in the set-up, running and strategic planning of future roles of the CTC. The CTC executive officers include a chair (on a 3 year term basis, with opportunity to extend by a further term), a secretary (on a 3 year term basis, with opportunity to extend by a further term).To date, the chair and secretary have been: 2000-2003 Chair – Jane Apperly, Secretary - David Marks; 2003-2006: Chair - David Marks, Secretary - Gordon Cook; 2006- present: Chair – Gordon Cook, Secretary - Emma Morris. The chair and secretary are supported by Keiren Towlson the BSBMT Senior Data manager, Rachel Pearce the BSBMT Biostatistician and more recently, the administrative services of Patricia Pound have been enrolled to help in the set-up and running of the meetings. The CTC was able to secure a 3 year Leukaemia Research Grant in 2003 to support the creation of an additional Data manager post (Marie Wilson) which has enabled Keiren Towlson to expedite CTC studies and collate data for SCT Purchasing organisation.

It was the intention for the CTC to meet 3-4 times per annum, with at least 2 meetings per year based in the London city area. To date there have been 22 meetings and the current mailing list for meetings notifications, agenda and minute circulation includes 86 Directors, Consultants & SpRs. Those invited are encouraged to participate in the discussions around trial design and conduct. Further information about the timings, locations and agendas form the meetings are posted on the society’s website (www.bsbmt.org). The average attendance at the meetings is around 15 but has varied from 10 to 22.

The main output from the CTC is the publication of scientific papers. This includes letters in Blood and BJH, Position papers and abstracts at national and international meetings (ASH, EBMT, BSH). In addition, the CTC has a session on the programme at both the BSBMT Scientific and Educational Days. The CTC has contributed to published National Guidelines including the BCSH Multiple Myeloma, Amyloid and (soon to be published) Mantle Cell Lymphoma guidelines. To date the CTC has published thirteen papers in peer reviewed journals.

Current open prospective studies include the National haplo-identical transplant study (CTC 03-02; PI: Eduardo Olivaria), A prospective study of Valganciclovir in the setting of CMV reactivation post RIC Allo-SCT (CTC 02-02, PI: A Pagliuca) and the Multi-centre International Fungal prophylaxis study (CTC 06-01; PI: David Marks, Gordon Cook, Chris Kibbler), in partnership with Pfiser. Current, on going retrospective studies include RIC Allo-SCT in AML (CTC 04-04), RIC Allo-SCT following relapse after a first allogeneic transplant for haematological Malignancies (CTC 04-05), Allo-SCT in Myelofibrosis (CTC 06-03), Allo-SCT in Elderly patients (CTC 06-02) and A retrospective analysis of G-CSF PBSC & BM in RIC Allo-SCT for ALL (CTC 06-05). Prospective studies currently in the planning stage include Transplantation of UBC from MUD in patients with haematological disease using a non-myeloablative preparative regimen (CTC-0402, PI: R Hough), UKMF/BSBMT Myeloma X R(Intensive) study (CTC-0603, PI: G Cook) and A phase II study of BEAM-CAMPATH RIC Allo-SCT in MCL (PI: S Rule, N Russell, G Cook). Retrospective studies being developed include The role of ASCT in patients with refractory MM (CTC 06-04), Outcome of Allo-SCT in CML >CP2 following Glivec (PI:D Marks) and EBV Reactivation post Allo-SCT (PI: A Clark)

In addition to building on our foundation of retrospective studies, clearly the way forward is to develop a portfolio of prospective studies. Such a portfolio would include national phase I/II studies and the development of international collaboration in developing RCT/Phase III e.g. German BMT Group, Nordic Group, EBMT, US CTN. Furthermore, it is the aim of the CTC to devlope stronger links with national disease-specific groups e.g. UK CLL Forum, UKMF, MDS Forum, and the CTC now has representation on the NCRI Haem-Onc CSG. Lastly, building on the tradition laid out in the early meetings, it is firmly within the remit of the CTC to encourage the involvement by trainees to develop their interest in SCT.

The next meeting (CTC #24) is Friday 28th September 13:30 - 16:30, at the Royal Institute of British Architects (RIBA), Portland Place.
London. Buffet lunch from 13:00.