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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02310997
Other study ID # UCL/09/0128
Secondary ID 2009-011818-21
Status Terminated
Phase Phase 2
First received September 18, 2014
Last updated May 26, 2015
Start date July 2011
Est. completion date May 2015

Study information

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

Clinical Trial 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.


Description:

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Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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Sponsors (2)

Lead Sponsor Collaborator
University College, London Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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