Study Stopped
Trial closed early due to poor recruitment
Myloablative Cord Blood Transplant in Haematological Malignancies (MAC UCBT)
MAC UCBT
Transplantation Of Umbilical Cord Blood From Unrelated Donors In Patients With Haematological Diseases Using A Myeloablative Conditioning Regimen
2 other identifiers
interventional
11
1 country
12
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2011
Typical duration for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 18, 2014
CompletedFirst Posted
Study publicly available on registry
December 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMay 27, 2015
May 1, 2015
3.8 years
September 18, 2014
May 26, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Non-relapse mortality at 100 days post transplant
100 days post transplant
Secondary Outcomes (5)
Overall survival at 1 year
1 year post transplant
Time course of mixed chimerism established by the donor graft
28, 60, 100 days, 6 months, 1 year post transplant
Recovery from neutropenia and cytopenia
up to 1 year post transplant
Incidence of acute and chronic GVHD
100 Days and 1 year post transplant
Incidence of relapse
1 year post transplant
Study Arms (2)
Fludarabine + Cyclophosphamide + TBI
EXPERIMENTALPatients aged 2-45 years (excluding AML, JMML and MDS patients aged \<16 years) will receive an umbilical cord blood transplant using a myeloablative conditioning regimen comprising: Fludarabine 25mg/m\^2/day day -8 to -6 (total 75mg/m\^2) Cyclophosphamide 60mg/kg day -7 and -6 (total 120mg/kg) Total body irradiation 13 - 14.4Gy in 6-8 fractions
Busulfan + Cyclophosphamide + Melphalan
EXPERIMENTALPatients aged \< 2 years and AML, JMML and MDS patients \<16 years will receive an umbilical cord blood transplant using a myeloablative conditioning regimen comprising: Busulfan 3.2mg/kg/day in 2 or 4 doses per day, days -9 to -6 (total 12.8mg/kg). Cyclophosphamide 60mg/kg days -4 and -3 (total 120mg/kg) Melphalan 140mg/m\^2 day -2
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College, Londonlead
- Cancer Research UKcollaborator
Study Sites (12)
University College London Hospital
London, Greater London, W1T 4TJ, United Kingdom
University Hospital Birmingham
Birmingham, B15 2TH, United Kingdom
Bristol Haematology & Oncology Centre
Bristol, BS2 8ED, United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
St James' University Hospital
Leeds, LS9 7TF, United Kingdom
St Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
Great Ormond Street Hospital for Children
London, WC1N 3JH, United Kingdom
Manchester Royal Infirmary
Manchester, M13 9WL, United Kingdom
Christie Hospital NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Royal Hallamshire Hospital
Sheffield, S10 2JF, United Kingdom
Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rachael Hough
University College London Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2014
First Posted
December 8, 2014
Study Start
July 1, 2011
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
May 27, 2015
Record last verified: 2015-05