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

Phase 2

Completed

Conditions: Andere hematologische maligniteiten (multipel myeloom, lymfoom)
hematological malignant diseases
10024324

Registration Number: NL-OMON37250

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

• Age > 18 years
• 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 10/10 matched donor (matched for HLA-A, B, C, DR and DQ)
• Life expectation of > 3 months
• WHO performance status of 0, 1 or 2
• Written informed consent according to the rules and regulations of the Leiden University Medical Center.

Exclusion Criteria

• Use of systemic immunosuppressive treatment (due to GVHD)
• Acute GVHD of the skin > grade 2 or progressive acute GVHD
• Progressive disease needing cytoreductive treatment
• Any concomitant disease preventing the safe administration of donor lymphocytes
• Severe psychological disturbances
• Severely limited life expectation due to diseases other than the malignancy
• Very high risk disease preceding allo-SCT for which already unselected DLI is planned to be given 3 months after allo-SCT.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• The number of circulating naïve CD4+ lymphocytes 4.5 months after allo-SCT.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Chimerism of circulating lymphocytes.<br /><br>• Transplantation related complications between 3 and 12 months after the<br /><br>transplantation (CMV disease or CMV reactivation needing systemic treatment,<br /><br>EBV reactivation needing systemic treatment, VZV infection, other infections<br /><br>for which hospitalization, GVHD needing systemic treatment, auto-immune<br /><br>disorders needing systemic treatment).</p><br>