MAC UCBT

• Research type

  Research Study

• Full title

  Transplantation of umbilical cord blood from unrelated donors in patients with haematological diseases using a myeloablative conditioning regimen

• IRAS ID

  16216

• Contact name

  Rachael E Hough

• Sponsor organisation

  University College London

• Eudract number

  2009-011818-21

• Clinicaltrials.gov Identifier

  TBA

• Research summary

  Umbilical cord blood (UCB) transplantation is an effective therapy for treating patients with advanced or high risk haematological diseases who have no suitable related or unrelated blood or bone marrow donors. This trial is using an approach developed by the University of Minnesota; UCB is used as the stem cell source and two units are used if one unit is not sufficient. This University of Minnesota approach has been shown to work well. The anti-malignancy effect of this treatment is achieved by a combination of intensive chemoradiotherapy and the 'graft vs. malignancy' (GVM) effect. The advantage of this approach is the increased likelihood of destroying the malignant cells and a reduced risk of graft rejection as the bone marrow is better prepared to accept the transplant than with reduced intensity conditioning. However, the treatment may be less well tolerated by some patients and therefore patients of advanced age or with impaired organ function are not eligible for this trial.These patients will have exhausted all other conventional forms of treatment and this is the only treatment option available to them, without which their prognosis is extremely poor. This trial aims to verify the safety and efficacy of the approach used by the doctors in Minnesota in the context of a multi-institution UK setting. It also aims to establish whether this type of transplant is effective in children as well as adults. In addition it aims to assess how well the immune system regenerates after transplantation and what the risk is that this group of patients will relapse during post-transplant follow-up.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  10/H0711/45

• Date of REC Opinion

  21 May 2010

• REC opinion

  Favourable Opinion