N/A
ID
Bron
Verkorte titel
Aandoening
hematologische maligniteiten - hematological malignancies
allogene stamceltranplantatie - allogeneic stem cell transplantation
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The number of circulating naïve CD4+ lymphocytes 4.5 months after allo-SCT.
Achtergrond van het onderzoek
This 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.
Doel van het onderzoek
N/A
Onderzoeksopzet
14, 20 and 26 weeks after alloSCT.
Onderzoeksproduct en/of interventie
Infusion of CD4+ donor lymphocytes 3 months after transplantation.
Publiek
Postbus 9600
C.J.M. Halkes
Leiden 2300 RC
The Netherlands
+31 (0)71 5262261
Wetenschappelijk
Postbus 9600
C.J.M. Halkes
Leiden 2300 RC
The Netherlands
+31 (0)71 5262261
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL3446 |
NTR-old | NTR3597 |
Ander register | METC LUMC : 2012-01 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |