Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Myloablative Cord Blood Transplant in Haematological Malignancies (MAC UCBT) (MAC UCBT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02310997
Recruitment Status : Terminated (Trial closed early due to poor recruitment)
First Posted : December 8, 2014
Last Update Posted : May 27, 2015
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
University College, London

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.


Condition or disease Intervention/treatment Phase
Leukaemia Lymphoma Other Haematological Diseases Other: Umbilical Cord Blood Transplant Drug: Cyclophosphamide Radiation: Total body irradiation Drug: Busulfan Drug: Melphalan Drug: Fludarabine Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transplantation Of Umbilical Cord Blood From Unrelated Donors In Patients With Haematological Diseases Using A Myeloablative Conditioning Regimen
Study Start Date : July 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fludarabine + Cyclophosphamide + TBI

Patients 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

Other: Umbilical Cord Blood Transplant
Drug: Cyclophosphamide
Radiation: Total body irradiation
Drug: Fludarabine
Experimental: Busulfan + Cyclophosphamide + Melphalan

Patients 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

Other: Umbilical Cord Blood Transplant
Drug: Cyclophosphamide
Drug: Busulfan
Drug: Melphalan



Primary Outcome Measures :
  1. Non-relapse mortality at 100 days post transplant [ Time Frame: 100 days post transplant ]

Secondary Outcome Measures :
  1. Overall survival at 1 year [ Time Frame: 1 year post transplant ]
  2. Time course of mixed chimerism established by the donor graft [ Time Frame: 28, 60, 100 days, 6 months, 1 year post transplant ]
  3. Recovery from neutropenia and cytopenia [ Time Frame: up to 1 year post transplant ]
  4. Incidence of acute and chronic GVHD [ Time Frame: 100 Days and 1 year post transplant ]
  5. Incidence of relapse [ Time Frame: 1 year post transplant ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310997


Locations
Layout table for location information
United Kingdom
University College London Hospital
London, Greater London, United Kingdom, W1T 4TJ
University Hospital Birmingham
Birmingham, United Kingdom, B15 2TH
Bristol Haematology & Oncology Centre
Bristol, United Kingdom, BS2 8ED
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
St James' University Hospital
Leeds, United Kingdom, LS9 7TF
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Great Ormond Street Hospital for Children
London, United Kingdom, WC1N 3JH
Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
Christie Hospital NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1PB
Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
University College, London
Cancer Research UK
Investigators
Layout table for investigator information
Principal Investigator: Rachael Hough University College London Hospital
Layout table for additonal information
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02310997    
Other Study ID Numbers: UCL/09/0128
2009-011818-21 ( EudraCT Number )
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Cyclophosphamide
Melphalan
Busulfan
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists