Condition category
Cancer
Date applied
31/08/2007
Date assigned
27/06/2008
Last edited
14/11/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.lumc.nl

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

  1. 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.

Additional files

Editorial Notes