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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37250

Enrollment

Registered

2012-06-08

Start date

2012-10-18

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

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

Interventions

Infusion of CD4+ lymphocytes at three months after the transplantation

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
• The number of circulating naïve CD4+ lymphocytes 4.5 months after allo-SCT.	—

Secondary

Measure	Time frame
• Chimerism of circulating lymphocytes. • 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).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)