Prophylactic infusion of CD4 positive donor lymphocytes early after T-cell depleted allogeneic stem cell transplantation in patients with an unrelated donor.
Recruiting
- Conditions
- hematologische maligniteiten - hematological malignanciesallogene stamceltranplantatie - allogeneic stem cell transplantation
- Registration Number
- NL-OMON20464
- Lead Sponsor
- eiden University Medical Center (LUMC)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
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;
Exclusion Criteria
1. Use of systemic immunosuppressive treatment (due to GVHD);
2. Acute GVHD of the skin > grade 2 or progressive acute GVHD;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of circulating naïve CD4+ lymphocytes 4.5 months after allo-SCT.
- Secondary Outcome Measures
Name Time Method 1. Lymphocyte chimerism status;<br /><br>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).