UK Haplo

Trial Overview

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

Inclusion criteria

  1. Age 16-70
  2. Adequate physical function
    1. Cardiac: LVEF at rest ≥45%, or shortening fraction ≥25%
    2. Hepatic: Bilirubin ≤35mmol/l; AST/ALT and alkaline phosphatase <5 x ULN
    3. Renal: Serum creatinine within normal range for age, or if serum creatinine outside normal range for age, creatinine clearance or GFR >40ml/min/1.73m2
    4. Pulmonary: FEV1, FVC, DLCO (diffusion capacity) >50% predicted (corrected for haemoglobin); if unable to perform pulmonary function tests then O2 saturation >92% on room air
    5. Performance status: Karnofsky score ≥60%
  3. Donor available aged ≥16 years
  4. Needs an urgent transplant where a suitable HLA matched sibling or unrelated donor is unavailable in a timely manner. An unrelated donor search is not required for a patient to be eligible if the clinical situation dictates an urgent transplant. Clinical urgency is defined as 6-8 weeks from referral to transplant centre or low likelihood of finding a matched unrelated donor
  5. Transplant where a suitable HLA matched donor is unavailable
  6. HLA typing will be performed at high resolution (allelic) for the HLA-A, HLA-B, HLA-Cw, HLA-DRB1 and HLA-DQB1 loci. A minimum match of 5/10 is required
  7. The donor and recipient must be identical as determined by high resolution typing at at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1 and HLA-DQB1. Fulfilment of this criterion is sufficient evidence that the donor and recipient share one HLA haplotype and typing of additional family members is not required.
  8. Patient must have received cytotoxic chemotherapy within 3 months of the consent date (measured from the start date of chemotherapy) except patients with aplastic anaemia), unless otherwise agreed by the TMG (see section 5.3.4)
  9. Written informed consent

Exclusion criteria

  1. HLA matched, related donor able to donate
  2. Autologous haematopoietic stem cell transplant <3 months prior to enrolment
  3. Pregnancy or breastfeeding
  4. Uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiological findings), unless otherwise agreed by the TMG (see section 5.3.4)
  5. Serious psychiatric or psychological disorders
  6. Absence or inability to provide informed consent
  7. Severe comorbidity (HCT-CI comorbidity score of 3 or more) or disease that prevents treatment with chemotherapy, unless otherwise agreed by the TMG (see section 5.3.4)
  8. Positive anti-donor HLA antibody
  9. Unable to receive 2Gy TBI (RIC pathway) or 12Gy TBI (MAC pathway)
  10. Patients with graft rejection following a previous allograft from either adult or cord blood donors

Research Nurse

Stewart McConnell

Tel: 01132068577


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