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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN51398568
Enrollment
60
Registered
2008-06-27
Start date
2008-07-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Haematological malignancy Cancer Leukaemia of unspecified cell type

Interventions

Infusion with CD4 positive donor lymphocytes vs standard care.

Sponsors

Leiden University Medical Centre (Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Both males and females 2. Age from 18 to 70 years 3. Patients with acute myeloid leukaemia (AML), myelodysplasia (MDS), acute lymphocytic leukaemia (ALL), chronic myeloid leukaemia (CML) in accelerated phase or blastic transformation, chronic lymphocytic leukaemia (CLL), multiple myeloma (MM) or aggressive lymphoma, who received an allogeneic stem cell transplantation.

Exclusion criteria

Exclusion criteria: 1. Systemic immunosuppressive treatment 2. Progressive Graft Versus Host Disease (GVHD) 3. GVHD of the skin greater than grade 2 4. Progressive disease needing cytoreductive treatment

Design outcomes

Primary

MeasureTime frame
Immune reconstitution at 6 months.

Secondary

MeasureTime frame
1. Chimerism and disease status as measured by minimal residual disease at 6 months 2. Incidence of viral infections between 3 and 6 months

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026