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MINUTES OF BSBMT CTC NO 23 MEETING THURSDAY, 26th APRIL 2007
Cameron Room, Windeyer Institue, UCL, London
Present:
Gordon Cook (Chair), Leeds
Emma Morris (Secretary), UCL
Keiren Towlson, BSBMT
Maria Wilson, BSBMT
Rachel Pearce, BSBMT
Tim Littlewood, Oxford
Effie Liakopoulou, Christie
Debbie Richardson, Southampton
Kim Orchard, Southampton
Anne Parker, Glasgow
Steve Robinson, Bristol
Jamie Cavanagh, The Royal London and Barts
Kirsty Thomson, UCLH
Karl Peggs, UCLH
Dragana Milojkovic, Hammersmith
Suparno Chakrabarti, St George’s
Bronwen Shaw, Royal Marsden and Anthony Nolan
Ian Gabriel, SpR Hammersmith
RFH SpR
Jerry Brown, Snr Lecturer Respiratory Medicine, UCL
1. Chairman’s Welcome
GC welcomed all attendees. It was indicated that this was the first meeting with GC as Chair and EM as Secretary.
2. Apologies
Apologies were received from Tony Pagliuca, Jenny Byrne, Nigel Russell, Alysius Ho, Curly Morris, Panos Kottaridis, Rachel Hough, Tessa Holyoake, Don Milligan. **
3. Previous Minutes (CTC 22, 06/06/06, London)
The Minutes of the last meeting were passed as a true representation. EM was advised in future to circulate these with the agenda for the forthcoming meeting.
4. Manuscript Development Update
  1. i.The Peripheral T Cell Lymphoma paper has been revised and returned to Bone Marrow Transplantation following referees’ comments.
  2. ii.The Mantle Cell Lymphoma paper was rejected by the Journal of Clinical Oncology. In order for this to be re-submitted to another journal the data-set needs to be updated and requests for information will be sent to participating centres. There is likely to be a change in authorship to reflect the requirement to re-write the manuscript.
  3. iii.The Waldenstrom’s paper has been completed and is pending author signatures prior to submission to Bone Marrow Transplantation.
5. New Study Proposals - Updates
5.1 Lung Function and Allo-SCT (J Brown, UCL)
Jerry Brown presented a proposal to examine retrospectively lung function abnormalities following allogeneic stem cell transplantation. There is little good published data including none from the UK and very limited data on the natural history of bronchiolitis obliterans (BO). JB hopes that such a study could determine whether treatment interventions were more likely to be useful if instituted early in the course of disease and whether efficacy of treatment types varied at different stages in the development of BO. The overall aim of the study would be to define a risk group who would benefit from more intensive pulmonary monitoring. The study would aim to determine the incidence and type of PFT abnormalities pre and post allogeneic HSCT. Data required in addition to the ‘standard’ transplant data set would be PFTs (spirometry, transfer factor, absolute values, predicted values), clinical diagnosis of lung pathology, HR CT Chest, Lung biopsy. It was noted that a significant proportion of lung pathology was likely to be infection related. There was general agreement that this study would be both interesting and useful, with the potential to change practice. However, a number of practical problems were commented on: (i) the majority of centres do not routinely perform PFTs pre-transplant, (ii) the are no identifiable markers to pull information on affected individuals from the BSBMT data base.TL commented that PFTs were rarely done prior to RIC allografts, but the incidence of pulmonary complications, particularly in the older patients was significant. JB is keen to use data collected from the retrospective study to design a prospective study. BS commented that the EBMT late effects group may have been collecting data on pulmonary dysfunction post transplant. It was concluded that a questionnaire should be designed to determine which centres collect PFT data and their willingness to participate in a retrospective study. A prospective study would be welcomed by the majority of transplant centres.
    1. iii..2Prospective Study of BEAM-Campath RIC Allografts for MCL (S Rule, Plymouth; N Russell, Nottingham; G Cook, Leeds)
A grant application has been submitted for funding to proceed. ***
    1. iii..3Allo-SCT for CML in > CP2 following Glivec (Kelly & D Marks, Bristol)
As of July 2006 there were in excess of 200 identifiable patients who had proceeded to allograft for advanced phase CML, including 59 with 2nd transplants.
5.4 Retrospective Study of ASCT for Refractory MM (G Cook, Leeds; J Bird, Bristol; CTC-0604)
This proposed retrospective study was discussed briefly at CTC 22. It aims to study the impact of ASCT in the management of refractory and progressive MM. A protocol summary has been written and sent to 3 reviewers for comments ± approval.
    1. iii..4EBV Reactivation and Monitoring post Allo-SCT (A Parker and A Clark, Glasgow)
A long discussion was held regarding the value of such a study and the intrinsic difficulties it presents. There are widely differing practices regarding the monitoring of EBV viral load post transplant, the definition of PTLD (rising viral load alone, or the presence of clinical signs) and the therapeutic intervention. Major concerns from KTow and KP, respectively, are (i) the lack of EBV data on MedA forms, (ii) non-standardised PCR-based assays (whole blood or serum), which is likely to preclude an informative multi-centre study. SC commented that recently reviewed St Georges data was presented at EBMT this year. There was general support for a fact-finding questionnaire to be sent to centres to document current practice. A full proposal once submitted, including preliminary questionnaire, will be sent to reviewers for comment ± approval.
    1. iii..5Treosulfan in Allo-SCT (A Parker, Glasgow)
AP presented Glasgow’s 5 year experience of using Treo/Cyclo ± Alemtuzumab conditioning for poor risk haematological malignancies. To date, 12 patients have been treated with a median age of 42 years and a median follow up of 368 days. There were 4 matched sibling and 8 MUD allografts. The conditioning regimen consisted of treosulfan 14mg/m2 (D-6 to D-4), cyclophosphamide 60mg/kg (D-3 and D-2), Alemtuzumab 10mg BD (D-6 to D-1). Current OS is 30-40%. AP has secured funding for data management, free Treosulfan and pharmacovigilence if others were keen to join a multi-centre Phase II study. KO asked whether the Treo dose is equivalent to standard Busulfan dosing. AP replied that the dose equivalence was lower than Bu, but the MTD of Treo. SR commented that there may be support for such a protocol to examine the role of re-intensified conditioning. AP to submit a Trial Proposal and questionnaire to determine the level of interest in such a study.
    1. iii..6Non-myeloablative Allo-SCT for Renal Cell Carcinoma (E Liakopoulou, Christie)
EL was keen to determine the level of interest in a National protocol for NSCT in RCC. Apparently, to date 120 patients have been treated across Europe and survival is approximately 70% at 1-2 years (recently presented at EBMT). SC would be keen to participate in such a study. TL commented that such a proposal would require close working relationships with oncologists, from whom patients would be referred and that their views should be sought. In addition, he was concerned there might be significant commissioning issues. KO commented that there are competing new agents available for such end stage patients. General opinion was that a fully funded local pilot study should be performed prior to consideration of a National study.
6. Current Studies
6.1 Valganciclovir Study (CTC 02-02, Pagliuca):
In the absence of Tony Pagliuca, EM presented that recruitment has completed and the results are being analysed.
6.2 Imatinib and Reduced Intensity HSCT in newly diagnosed CML (CTC 03-01, Holyoake):
TH had prepared some summary slides, which were presented by EM in her absence. The study is now closed.
6.3 Haplo-Identical Transplant Study (CTC 03-02, Olavarrio):
No update had been received by EO prior to CTC 23. EM to follow up.
    1. iii..4Non-myeloablative Cord Blood Transplantation for Haematological Malignancies (CTC-04-02, Hough):
EM indicated in the absence of Rachel Hough that problems had been highlighted regarding stopping criteria and the fact that sponsorship had to be transferred to UCH from Sheffield. Continues as work in progress.
    1. iii..5RIC Allo SCT in AML (CTC 04-04, Peniket):
TL indicated that a manuscript first draft has been completed and is to be circulated to co-authors.
    1. iii..6RIC Allo-HSCT following relapse after a first allogeneic transplant for haematological malignancies (CTC 04-05, Shaw):
BS presented the data, which has been presented in abstract form at EBMT. The dataset includes a total of 71 patients. At 2 years, OS was 28%, Relapse Rate 50% and TRM 28%.
    1. iii..7UKMF/BSBMT Myeloma X R (Intensive) Prospective Study (CTC 05-02, G Cook):
Funding (CRUK) and Sponsorship are in place. CoREC application has been sent. It is anticipated the study will open Oct 2007. 460 patients need to be recruited in order for 400 to be randomised. Re-induction will be with velcade, adriamycin and dexamethasone, followed by re-mobilisation. Patients will then be randomised between receiving HDM and ASCT or LD oral cyclophosphamide. The primary endpoint will be TTP.
    1. iii..8Randomised Prospective study of Fungal Prophylaxis in MUD HSCT (CTC 06-01, G Cook and D Marks):
This trial is open and recruiting patients in both Spain and the UK.
    1. iii..9Retrospective study of Allo SCT in Elderly Patients (CTC 06-02, Cook):
Requests for data from the transplant centres will be sent out in May 2007. Aiming to collect data relating to toxicity including PM reports, where applicable, and data for determination of Seattle/Charleston Co-morbidity scoring.
    1. iii..10Retrospective Study of Allo SCT in Myelofibrosis (CTC 06-03, P Kottaridis):
Preliminary data on 50 patients has been collected and is yet to be analysed.
    1. iii..11Retrospective study of MUD Allo SCT in Ph Neg ALL (CTC 06-05, J Byrne):
74 patients have been identified on the database who have undergone MUD Allo for Ph Neg ALL. Data has been requested from the relevant transplant centres.
    1. iii..12AOCB
The frequency and location of CTC meetings was discussed. It was agreed that the next meeting should be in September in London. CTC members from centres outside of London noted that it was usually easier to travel to London than to another centre elsewhere in the country.
EM promised that an appropriately smart venue with catering would be organised for the next meeting.
It was noted that only a few PIs of current BSBMT CTC studies were present at the meeting and that every effort should be made for PIs to attend in future. In their absence, the discussion of their studies is of limited value.
8. Date and Time of Next Meeting
The next meeting will be set for mid-late September and will be in London.
EM has obtained an unrestricted Educational Grant for the meeting to be held at RIBA, Portland Place, London, following a buffet lunch.