Status:
TERMINATED
Myloablative Cord Blood Transplant in Haematological Malignancies (MAC UCBT)
Lead Sponsor:
University College, London
Collaborating Sponsors:
Cancer Research UK
Conditions:
Leukaemia
Lymphoma
Eligibility:
All Genders
28-45 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
During treatment for cancers of the bone marrow or lymphatic system, a lot of the stem cells are damaged and you may need a bone marrow or stem cell transplant to replace them. Stem cells can also be...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02310997
Start Date
July 1 2011
End Date
May 1 2015
Last Update
May 27 2015
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
University College London Hospital
London, Greater London, United Kingdom, W1T 4TJ
2
University Hospital Birmingham
Birmingham, United Kingdom, B15 2TH
3
Bristol Haematology & Oncology Centre
Bristol, United Kingdom, BS2 8ED
4
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ