Myloablative Cord Blood Transplant in Haematological Malignancies (MAC UCBT)

• Status: Terminated
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is looking at using umbilical cord blood from unrelated donors after high dose chemotherapy. It is for people who have cancer of the bone marrow or lymphatic system including leukaemia and lymphoma, or a blood disorder called myelodysplastic syndrome (MDS).

The trial is for babies over 4 weeks old, children, and adults up to the age of 45.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Collaborator: Cancer Research UK
• Treatments: Busulfan; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Melphalan

Criteria

Inclusion Criteria:

• Subjects must be < 45 years of age and ≥ 28 days old

• Patients with high risk, advanced or poorly responding haematological disease for which there is published evidence that haematopoietic stem cell transplantation using myeloablative conditioning is likely to be effective

• 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

• Left ventricular ejection fraction >45%

• Transaminases and bilirubin < twice the upper limit of the normal range

• Creatinine clearance > 60mls/min

• Comorbidity index of 0 or 1

Exclusion Criteria:

• Patients with a suitably matched sibling donor or 10/10 unrelated volunteer donor available within an acceptable time period.

• Pregnancy or breastfeeding.

• Evidence of HIV or HTLV (I+II) infection or known HIV or HTLV positive serology

• Current active serious infection, in particular uncontrolled fungal infection -Previous irradiation that precludes the safe administration of an additional dose of 13- 14.4 Gy of total body irradiation (TBI) in patients aged 2-45 years

• Prior autograft

• CML in first chronic phase responding to Imatinib or refractory blast crisis

• Patients with acute leukaemia in morphological relapse/ persistent disease (defined as > 5% blasts in normocellular bone marrow)

• Patients with acute myeloid leukaemia with relapse/persistent disease unresponsive to re-induction chemotherapy (defined as >20% blasts in normocellular bone marrow)

• Malignant disease that is refractory to or progressive on salvage therapy

• Myelofibrosis.

• Aplastic anaemia