NK DLI in Patients After Human Leukocyte Antigen (HLA)-Haploidentical Hematopoietic Stem Cell Transplantation (HSCT)

University Hospital Basel

Status and phase: Completed; Phase 2; Phase 1

Conditions: Neuroblastoma; Rhabdomyosarcoma; Leukemia, Myeloid, Acute; Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes

Treatments: Biological: CD3-depleted/CD56+ selected natural killer cells collected from apheresis products

Study type: Interventional

Funder types: Other

Identifiers

NCT01386619

NK-DLI Allo-Tx

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with acute/chronic leukemia, myelodysplastic syndrome, lymphoid neoplasia, solid tumor or bone marrow failure syndrome
• signed informed consent of the patient (or his/her legal representative)

Exclusion criteria

• Patients with graft failure
• Patients with any grade of active acute of chronic graft-versus-host disease (GvHD)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

NK cell DLI

Experimental group

Treatment:

Biological: CD3-depleted/CD56+ selected natural killer cells collected from apheresis products