Contact information
Type
Scientific
Primary contact
Prof J H F Falkenburg
ORCID ID
Contact details
Leiden University Medical Centre
Albunisdreef 2
Leiden
2333 ZA
Netherlands
+31 (0)71 526 2271
J.H.F.Falkenburg@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LUMC 2007-01
Study information
Scientific title
Acronym
Study hypothesis
Infusion of CD4 positive donor lymphocytes after T-cell depleted stem cell transplantation will increase immune reconstitution.
Ethics approval
Central Committee on Research involving Human Subjects, Netherlands (CCMO). Date of approval: 27/05/2008
Study design
Phase II, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Haematological malignancy
Intervention
Infusion with CD4 positive donor lymphocytes vs standard care.
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measures
Immune reconstitution at 6 months.
Secondary outcome measures
1. Chimerism and disease status as measured by minimal residual disease at 6 months
2. Incidence of viral infections between 3 and 6 months
Overall trial start date
01/07/2008
Overall trial end date
01/10/2010
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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
Recruitment start date
01/07/2008
Recruitment end date
01/10/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Centre
Leiden
2333 ZA
Netherlands
Sponsor information
Organisation
Leiden University Medical Centre (Netherlands)
Sponsor details
Albunisdreef 2
Leiden
2333 ZA
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Leiden University Medical Centre (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23777765
Publication citations
-
Results
Stevanovic S, van Bergen CA, van Luxemburg-Heijs SA, van der Zouwen B, Jordanova ES, Kruisselbrink AB, van de Meent M, Harskamp JC, Claas FH, Marijt EW, Zwaginga JJ, Halkes CJ, Jedema I, Griffioen M, Falkenburg JH, HLA class II upregulation during viral infection leads to HLA-DP-directed graft-versus-host disease after CD4+ donor lymphocyte infusion., Blood, 2013, 122, 11, 1963-1973, doi: 10.1182/blood-2012-12-470872.