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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2011-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NK cell DLI

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

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)

Interventions

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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)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)