Prophylactic infusion of CD4 positive donor lymphocytes early after T-cell depleted stem cell transplantatio

Phase 2

• Conditions: leukemia; 10024324; 10025322

• Registration Number: NL-OMON30913
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Patients with AML, myelodysplasia (MDS), ALL, CML in accelerated phase or blastic transformation, CLL, MM or aggressive lymphoma, who are scheduled to receive an allogeneic stem cell transplantation.

Exclusion Criteria

Systemic immunosuppressive treatment
Progressive GVHD
GVHD of the skin > grade 1
Progressive malignant disease needing cytoreductive treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective: To evaluate whether CD4+ lymphocytes infusion given three<br /><br>months after T-cell depleted allo-SCT improves immunological recovery, i.e.<br /><br>recovery of circulating CD4+ T cells with an incidence of GvHD requiring<br /><br>systemic treatment not exceeding 30%</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objective(s): To evaluate whether CD4+ lymphocytes infusion given<br /><br>three months after T-cell depleted allo-SCT influences chimerism, disease<br /><br>status as measured by minimal residual disease, appearance of virus specific T<br /><br>lymphocytes, and incidence of viral infections</p><br>