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Prophylactic infusion of CD4 positive donor lymphocytes early after T-cell depleted allogeneic stem cell transplantation in patients with an unrelated donor.


- candidate number13282
- NTR NumberNTR3597
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-sep-2012
- Secondary IDs2012-01 METC LUMC
- Public TitleProphylactic infusion of CD4 positive donor lymphocytes early after T-cell depleted allogeneic stem cell transplantation in patients with an unrelated donor.
- Scientific TitleProphylactic infusion of CD4 positive donor lymphocytes early after T-cell depleted allogeneic stem cell transplantation in patients with an unrelated donor.
- ACRONYMCD4+ donor lymphocyte infusion
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedHematological malignancy, Allogeneic stem cell transplantation
- Inclusion criteria1. Age > 18 years;
2. Patients with AML, myelodysplasia , ALL, CML in accelerated phase or blastic transformation, CLL, MM or (non) Hodgkin lymphoma, who underwent an allo-SCT with an unrelated donor who is matched for HLA-A, B, C, DR and DQ;
3. Life expectation of > 3 months;
4. WHO performance status of 0, 1 or 2;
5. Written informed consent according to the rules and regulations of the Leiden University Medical Center.
- Exclusion criteria1. Use of systemic immunosuppressive treatment (due to GVHD);
2. Acute GVHD of the skin > grade 2 or progressive acute GVHD;
3. Progressive disease needing cytoreductive treatment;
4. Any concomitant disease preventing the safe administration of donor lymphocytes;
5. Severe psychological disturbances;
6. Severely limited life expectation due to diseases other than the malignancy;
7. Very high risk disease preceding allo-SCT for which already unselected DLI is planned to be given 3 months after allo-SCT.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 3-sep-2012
- planned closingdate3-sep-2015
- Target number of participants60
- InterventionsInfusion of CD4+ donor lymphocytes 3 months after transplantation.
- Primary outcomeThe number of circulating na´ve CD4+ lymphocytes 4.5 months after allo-SCT.
- Secondary outcome1. Lymphocyte chimerism status;
2. Transplantation related complications between 3 and 12 months after the transplantation (CMV disease or CMV reactivation needing systemic treatment, EBV reactivation needing systemic treatment, VZV infection, other infections for which hospitalization, GVHD needing systemic treatment, auto-immune disorders needing systemic treatment).
- Timepoints14, 20 and 26 weeks after alloSCT.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. C.J.M. Halkes
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.H.F. Falkenburg
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryThis is an open-label randomized phase I/II study comparing CD4+ donor lymphocyte infusion versus no infusion at 3 months after an unrelated allogeneic stem cell transplantation for a hematological malignancy.
- Main changes (audit trail)
- RECORD3-sep-2012 - 12-sep-2012


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