Trials / Completed
CompletedNCT01386619
NK DLI in Patients After Human Leukocyte Antigen (HLA)-Haploidentical Hematopoietic Stem Cell Transplantation (HSCT)
Natural Killer Cell Selected T-cell Depleted Donor Lymphocyte Infusions (NK-DLI) in Patients After HLA-haploidentical Allogeneic Stem Cell Transplantation
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- University Hospital, Basel, Switzerland · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This is a phase I/II study of highly selected donor lymphocyte infusions in patients undergoing HLA-haploidentical hemopoietic stem cell transplantation. Patients will be offered "pre-emptive" NK-DLI early after HSCT. Three schedules of NK-cell infusion will be studied: Basel patients (adult and pediatric) will receive NK-DLI on days +40 and +100 (pre-emptive-late); Frankfurt patients (pediatric) will receive NK-DLI on days +3, +40, and +100 (pre-emptive early). Patients not receiving pre-emptive NK-DLI with loss in donor chimerism or with evidence of minimal residual disease will be offered "therapeutic" NK-DLI.
Conditions
- Leukemia, Myeloid, Acute
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Myelodysplastic Syndromes
- Lymphoma
- Neuroblastoma
- Rhabdomyosarcoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CD3-depleted/CD56+ selected natural killer cells collected from apheresis products | NK DLI products containing \>1 10e7 NK cells/kg bodyweight (BW) and \< 1 x 10e5 T-cells/kg BW are administered at days +4 (Frankfurt only), and on days +40 and +100 (both centers) |
Timeline
- Start date
- 2004-01-01
- Primary completion
- 2011-03-01
- Completion
- 2011-03-01
- First posted
- 2011-07-01
- Last updated
- 2024-03-19
Locations
2 sites across 2 countries: Germany, Switzerland
Source: ClinicalTrials.gov record NCT01386619. Inclusion in this directory is not an endorsement.