UK Haplo v1.0

  • Research type

    Research Study

  • Full title

    A UK multicentre phase II study of haploidentical stem cell transplantation in patients with haematological malignancies

  • IRAS ID

    96505

  • Contact name

    Kavita Raj

  • Sponsor organisation

    University College London

  • Eudract number

    2011-005889-38

  • Clinicaltrials.gov Identifier

    NCT01597219

  • Research summary

    Stem cell transplantation has been used for many years in the treatment of cancers that affect the blood, bone marrow and lymphatic system. Most transplants use blood forming cells (??stem cells??). If the patient??s own cells are infused, this is called an ??autologous transplant??, and if cells are from another person, this is called an ??allogeneic transplant??. The stem cells can take the form of either bone marrow or stem cells harvested from the donor??s blood using a process called ??apheresis??, whereby blood is taken from the donor and passed through a cell separating machine which takes out the cells we want to use ?? the rest of the blood is returned to the donor??s body. In most allogeneic transplants, cells are donated by someone who is genetically very similar to the patient - either the patient??s brother or sister (a ??sibling donor??), or an unrelated donor identified by a process of matching through a donor registry. However, as many as 1 in 3 patients do not have a fully matched sibling or volunteer unrelated donor. There are other options for these patients, which include transplants of blood from umbilical cords, or a ??haploidentical transplant?? which is a ??half matched?? transplant, and donors are usually the patient??s parents or children. Historically, haploidentical transplants have been difficult to perform as the less well matched cells cause complications such as graft versus host disease. However, researchers in the USA have recently developed new haploidentical transplantation methods with improved results. This trial will test these new techniques at a number of hospitals in the UK. Two treatments being tested - an intensive ('myeloablative') transplant and a reduced intensity transplant. The primary aim of the trial is to improve survival at one year post transplant, but the study will also look at the side effects of the transplants and quality of life.

  • REC name

    London - Bloomsbury Research Ethics Committee

  • REC reference

    12/LO/1201

  • Date of REC Opinion

    29 Aug 2012

  • REC opinion

    Further Information Favourable Opinion