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

Prophylactic infusion of CD4 positive donor lymphocytes early after T-cell depleted stem cell transplantation - CD4 positive lymphocyte infusion after alloSCT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31838

Enrollment

Registered

2008-03-19

Start date

2008-07-04

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Interventions

The intervention is the infusion of a subset of donor lymphocytes (the CD4+ cells), three months after stem cell transplantation.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Systemic immunosuppressive treatment Progressive GVHD GVHD of the skin > grade 2 Progressive malignant disease needing cytoreductive treatment

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)