Lymphoma Clinical Trial
— MAC UCBTOfficial title:
Transplantation Of Umbilical Cord Blood From Unrelated Donors In Patients With Haematological Diseases Using A Myeloablative Conditioning Regimen
Verified date | May 2015 |
Source | University College, London |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 11 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 45 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospital Birmingham | Birmingham | |
United Kingdom | Bristol Haematology & Oncology Centre | Bristol | |
United Kingdom | Addenbrooke's Hospital | Cambridge | |
United Kingdom | St James' University Hospital | Leeds | |
United Kingdom | Great Ormond Street Hospital for Children | London | |
United Kingdom | St Bartholomew's Hospital | London | |
United Kingdom | University College London Hospital | London | Greater London |
United Kingdom | Christie Hospital NHS Foundation Trust | Manchester | |
United Kingdom | Manchester Royal Infirmary | Manchester | |
United Kingdom | Nottingham City Hospital | Nottingham | |
United Kingdom | Royal Hallamshire Hospital | Sheffield | |
United Kingdom | Royal Marsden Hospital | Sutton |
Lead Sponsor | Collaborator |
---|---|
University College, London | Cancer Research UK |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Non-relapse mortality at 100 days post transplant | 100 days post transplant | Yes | |
Secondary | Overall survival at 1 year | 1 year post transplant | Yes | |
Secondary | Time course of mixed chimerism established by the donor graft | 28, 60, 100 days, 6 months, 1 year post transplant | No | |
Secondary | Recovery from neutropenia and cytopenia | up to 1 year post transplant | Yes | |
Secondary | Incidence of acute and chronic GVHD | 100 Days and 1 year post transplant | Yes | |
Secondary | Incidence of relapse | 1 year post transplant | No |
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