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

Phase 1

Completed

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

• Registration Number: NCT01386619
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2011-06-07
• Study First Submitted QC: 2011-06-30
• Study First Posted: 2011-07-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of NK-DLI production	At day of transplant (day 0)	The feasibility of the production of expanded NK-cell DLI will be measured. Primary quality measures of the NK cell product are the number of NK cells that can be produced (CD56+/cluster of differentiation 3(CD3)- NK cell goal dose \>= 1 \* 10e7/kg body weight of recipient) as well as the degree of CD3 T-cell contamination (goal CD3+ T-cell dose \< 1 \* 10e5 / kg body weight of recipient).
Safety of NK DLI Infusion	Day +60 after transplant	The safety evaluation regards transfusion associated adverse events (fever, fall in blood pressure, transfusion site reactions, etc) and is evaluated at the time of NK DLI infusion. The primary long-term safety measure is the absence of acute graft-versus-host disease 30 days after the last NK DLI infusion.

Secondary Outcome Measures

Name	Time	Method
Efficacy of NK DLI Infusions	5 years after last NK DLI	The efficacy of NK DLI infusions will be assessed by evaluation of the rates of overall and disease free survival and the rate of disease relapse. As this is a single arm study, outcome measures assessed will be compared to those of historical controls treated with haploidentical HSCT without NK DLI infusions.

Trial Locations

Locations (2)

Universitätsklinikum; 🇩🇪 Frankfurt, Germany

University Hospital; 🇨🇭 Basel, Switzerland