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The Clinical research facility is part of the NIHR and is funded by the Department of Health
UK Haplo
Trial Overview
A UK multicentre phase II study of haploidentical stem cell transplantation in patients with haematological malignancies
Inclusion criteria
- Age 16-70
- Adequate physical function
- Cardiac: LVEF at rest ≥45%, or shortening fraction ≥25%
- Hepatic: Bilirubin ≤35mmol/l; AST/ALT and alkaline phosphatase <5 x ULN
- 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
- 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
- Performance status: Karnofsky score ≥60%
- Donor available aged ≥16 years
- 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
- Transplant where a suitable HLA matched donor is unavailable
- 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
- 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.
- 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)
- Written informed consent
Exclusion criteria
- HLA matched, related donor able to donate
- Autologous haematopoietic stem cell transplant <3 months prior to enrolment
- Pregnancy or breastfeeding
- 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)
- Serious psychiatric or psychological disorders
- Absence or inability to provide informed consent
- 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)
- Positive anti-donor HLA antibody
- Unable to receive 2Gy TBI (RIC pathway) or 12Gy TBI (MAC pathway)
- Patients with graft rejection following a previous allograft from either adult or cord blood donors
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