RIC UCBT

TRANSPLANTATION OF UMBILICAL CORD BLOOD FROM UNRELATED DONORS IN PATIENTS WITH HAEMATOLOGICAL DISEASES USING A REDUCED INTENSITY CONDITIONING REGIMEN

Graft Cell Dose and Graft HLA Criteria

1. Selection of appropriate units for specific patients will be overseen by the cord blood unit selection committee (Appendix 10, protocol).
2. Unit selection is based on cryopreserved total nucleated cell (TNC) dose and HLA-A,-B and –DRB1 match. HLA-A and –B must be matched at the antigen level and HLA-DRB1 at the allelic level.
3. All units must be ≥4/6 matched to the recipient. Double units must also be ≥4/6 matched to each other. This may include 0-2 antigen mismatches at the A or B or DRB1 loci.
4. If multiple units are available for a given degree of HLA match, the largest will be chosen.
5. Units will be selected according to the following algorithm - Please see attached document 1.
6. The CD34+ cell dose will not be used in unit selection unless 2 units of equal HLA match are within 0.3x107 TNC/kg of each other and are available from the same cord blood bank. In this instance, the unit with the larger CD34+ cell dose will be used.
7. Units will be preferentially selected from cord blood banks that have achieved FACT-NetCord accreditation to ensure the quality of the products used. The FACT-Netcord standards can be found at the following link: http://www.factwebsite.org/main.aspx?id=56.
8. An appropriate back up UCB graft for each patient should be reserved until engraftment has been observed.

Age & disease criteria
Patients must be ≤ 60 and ≥ 2 years old.
Patients with high risk, advanced or poorly responding haematological disease for which there is published evidence that reduced intensity (RIC) haematopoietic stem cell transplantation is likely to be effective
and
The individual patient’s disease status is such that there is no alternative therapy likely to achieve cure or provide a significant prolongation of disease-free survival.

Organ function and performance status criteria
Adequate organ function is defined as:
1. Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 35%.
2. Pulmonary: DLCO > 50% predicted
3. Liver: Transaminases < 5 x upper limit of normal and bilirubin < 3 x upper limit of normal.
4. Renal: Creatinine clearance > 50 ml/min.
5. Adequate performance status is defined as Karnofsky score > 60% or Lansky score ≥ 50% (paediatrics)(Appendix 1, protocol).

Prior treatment requirements
1. Current transplant: must be > 6 months after prior myeloablative transplant.

2. Prior autograft or exposure to combination chemotherapy in the six months preceding transplant (Please discuss with chief investigator or co-investigators if only one cycle of induction combination chemotherapy was administered)

1. Patients with an available 5-6/6 HLA-A, -B, -DRB1 matched sibling donor or 10/10 unrelated volunteer donor available within an acceptable time period.
2. Requirement for supplementary 02 administration
3. Pregnancy or breastfeeding.
4. Evidence of HIV or HTLV (I+II) infection or known HIV or HTLV positive serology.
5. Current active serious infection, in particular uncontrolled fungal infection.
6. Previous irradiation that precludes the safe administration of an additional dose of 200 cGy of total body irradiation (TBI).
7. CML in first chronic phase responding to Imatinib or refractory blast crisis.
8. Patients with acute leukaemia in morphological relapse/ persistent disease (defined as > 5% blasts in normocellular bone marrow).
9. Malignant disease that is refractory to or progressive on salvage therapy.
10.Myelofibrosis.
11.Acquired aplastic anaemia.
12.Congenital immune deficiencies.

Principal Investigator

Dr Gordon Cook

Tel 01132068433

Email gordon.cook@leedsth.nhs.uk

Research Nurse

Alex Stichler

Tel 01132068577

Email alex.stichler@leedsth.nhs.uk

Print this page

Email this page to a colleague