For the CTC Authorship policy - please see CTC_AUTHORSHIP_POLICY_Jan_09.docx

For the CTC Study Proposal Template - please see BSBMT_CTC_Study_Proposal_Template.doc

Clinical Trials Committee Report, June 2010

Gordon Cook (CTC Chair)

The 30th CTC was held on Friday 22nd January 2010 Winchester, Hants and the 31st meeting was held on Tuesday 19th May, 2010 at the BSH Headquarters, London.

I opened the meeting with an expression of gratitude to Emma Morris for all her work as the Secretary as she stood down. We then welcomed Bronwen Shaw as the new Secretary of the CTC. I presented the results of an audit performed by Keiren Kirkland and Julia Lee demontrating that 18/23 CTC studies have been completed and, of the 18, 12 have been published in journals with IF ranging from 3-10.5. The amount of time taken in the BSBMT office to download and send a study to centres is short and has got shorter every year. Further analysis of this audit is awaited and will be available through the website. The CTC process continues to evolve and a study processing SOP for retrospective studies is near to completion, and will complement the Authorship Policy, Study Proposal Template and Study Proposal Review Template.

At present there are 4 manuscripts from CTC studies in preparation or recently submitted. The Committee considered 6 new study proposals including 3 prospective studies. The 3 prospective studies included a full intensity protocol for UCB in patients with haematological disease, a collaborative study of the incidence of intra-cranial haemorrhage with NHS Blood & Transplant, and an initiative to develop a UK Haplo-identical BMT Protocol.

The CTC Trials portfolio contains 8 prospective and 6 retrospective studies currently open. The propective studies include 1 phase III prospective study (UKMF/BSBMT Myeloma X Study: CTC 05-02), the Phase II National Reduced Intensisty Double Cord protocol led by Rachael Hough (CTC 04-02), Prospective analsysis of outcome for AlloSCT patients with proven H1N1 infection (CTCP 09-03) and the Phase II Study of Allogeneic Stem Cell Transplantation in Mantle Cell Lymphoma (lead investigator Simon Rule: CTC 07-01). Of the retrospective studies, a collaboration with Dr Jerry Brown, Respiratory Physician at UCH (Pulmonary function testing post allogeneic stem cell transplantation: CTC 09-01) is underway as is the Retrospective comparison of outcome following ATG vs Alemtuzumab conditioning regimens in Allo SCT for SAA lead by Judith Marsh (CTCR 09-03) and a Retrospective Survey of the Outcomes of Reduced-Intensity Conditioned AlloSCT for Adult Acute Lymphoblastic Leukaemia lead by Andy Peniket and Patrick Medd (CTCR 10-01).

Finally, the next meeting planned for Wednesday the 20th of October and aims to be a shorter business meeting followed by an in-depth discussion, led by key speakers, on developing a UK protocol for haplo-identical AlloSCT. All are welcome. The venue is to be confirmed.

Gordon Cook

Chair, CTC

Upcoming BSBMT Clinical Trials Committe Meeting Agendas

Please click below to download the agenda for upcoming meetings

Past BSBMT Clinical Trials Committee Meeting Agendas

Please click below to download the agenda for previous meetings already held

BSBMT_CTC_Agenda # 31 Tuesday 18th May 2010, London

BSBMT_CTC_Agenda_# 30 Friday 22nd January 2010, Winchester

BSBMT_CTC_Agenda #29 Tuesday 8th September 2009, London