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

Conditions: Haematological disorders
MedDRA version: 15.1Level: HLTClassification code 10018847Term: Haematological disordersSystem Organ Class: 100000004851

Registration Number: EUCTR2009-011818-21-GB

Lead Sponsor: niversity College London

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1) Age 45 years or younger. Children under the age of 2 years are at an increased risk of long term complications of total body irradiation (TBI) and will therefore not recieve TBI (AML patients aged <16 years will also not receive TBI as chemotherapy-only conditioning is now accepted national practice for this population).
. The risk of haemopoietic stem cell transplantation increases with increasing age. Furthermore the myeloablative treatment regimen 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. Therfore the upper age limit of 45 years was chosen by consensus of leading UK transplant physicians for reasons of safety.

2) Umbilical cord blood graft available with an adequate cell dose and HLA match. The rates of engraftment and survival following umbilical cord blood transplantation are determined by the cell dose (total number of nucleated cells given to the patient) and the closeness of HLA match. A strict algorithm for unit selection will be used based on currently available data. Units selected for every patient will be approved by the 'cord blood selection committee' (CBSC) to ensure consistency and safety.

3) Disease for which an allogeneic haemopoietic stem cell transplant (HSCT) is indicated. The disease type and remission status of every patient will comply with internationally agreed criteria.

4) 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. These patients would have proceeded to a conventional transplant if a blood or marrow donor had been identified.

5) Adequate organ function & performance status. Strict criteria for adequate organ function will be used to optimise safety of the procedure. The criteria used in this protocol are more stringent than those used by the University of Minnesota to improve safety further.
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1) Availability of a conventional related or unrelated haemopoietic stem cell donor within an acceptable time period. Such donors represent the standard of care in UK transplantation and must remain the first choice where available.

2) Current active serious infection. The preparative regimen results in profound suppression of the white count and immune system. Patients with active serious infection, such as invasive fungus, could develop life-threatening infection after transplant and will therefore be excluded.

3) Previous irradiation that precludes the safe administration of 13.2Gy- 14.4Gy of total body irradiation (TBI) in patients over 2 years of age and AML patients over the age of 16. Every patient scheduled to recieve TBI will be reviewed by a radiation oncologist to ensure that this dose of TBI will be safe. Children under the age of 2 years are at an increased risk of long term complications and will therefore not recieve TBI (AML patients aged <16 years will also not receive TBI as chemotherapy-only conditioning is now accepted national practice for this population).

4) Prior autograft.