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Prophylactic infusion of CD4 positive donor lymphocytes early after T-cell depleted stem cell transplantation
ISRCTN ISRCTN51398568
DOI 10.1186/ISRCTN51398568
ClinicalTrials.gov identifier
EudraCT number
Public title Prophylactic infusion of CD4 positive donor lymphocytes early after T-cell depleted stem cell transplantation
Scientific title
Acronym N/A
Serial number at source LUMC 2007-01
Study hypothesis Infusion of CD4 positive donor lymphocytes after T-cell depleted stem cell transplantation will increase immune reconstitution.
Lay summary Not provided at time of registration
Ethics approval Central Committee on Research involving Human Subjects, Netherlands (CCMO). Date of approval: 27/05/2008
Study design Phase II, randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Haematological malignancy
Participants - inclusion criteria 1. Both males and females
2. Age from 18 to 70 years
3. Patients with acute myeloid leukaemia (AML), myelodysplasia (MDS), acute lymphocytic leukaemia (ALL), chronic myeloid leukaemia (CML) in accelerated phase or blastic transformation, chronic lymphocytic leukaemia (CLL), multiple myeloma (MM) or aggressive lymphoma, who received an allogeneic stem cell transplantation.
Participants - exclusion criteria 1. Systemic immunosuppressive treatment
2. Progressive Graft Versus Host Disease (GVHD)
3. GVHD of the skin greater than grade 2
4. Progressive disease needing cytoreductive treatment
Anticipated start date 01/07/2008
Anticipated end date 01/10/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 60
Interventions Infusion with CD4 positive donor lymphocytes vs standard care.
Primary outcome measure(s) Immune reconstitution at 6 months.
Secondary outcome measure(s) 1. Chimerism and disease status as measured by minimal residual disease at 6 months
2. Incidence of viral infections between 3 and 6 months
Sources of funding Leiden University Medical Centre (Netherlands)
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23777765
Contact name Prof  J H F  Falkenburg
  Address Leiden University Medical Centre
Albunisdreef 2
  City/town Leiden
  Zip/Postcode 2333 ZA
  Country Netherlands
  Tel +31 (0)71 526 2271
  Fax +31 (0)71 526 6755
  Email J.H.F.Falkenburg@lumc.nl
Sponsor Leiden University Medical Centre (Netherlands)
  Address Albunisdreef 2
  City/town Leiden
  Zip/Postcode 2333 ZA
  Country Netherlands
  Sponsor website: http://www.lumc.nl
Date applied 31/08/2007
Last edited 14/11/2013
Date ISRCTN assigned 27/06/2008
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