NCT01386619

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_1

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2011

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 1, 2011

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

7.2 years

First QC Date

June 7, 2011

Last Update Submit

March 18, 2024

Conditions

Leukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaMyelodysplastic SyndromesLymphomaNeuroblastomaRhabdomyosarcoma

Outcome Measures

Primary Outcomes (2)

  • Feasibility of NK-DLI production

    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).

    At day of transplant (day 0)

  • Safety of NK DLI Infusion

    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.

    Day +60 after transplant

Secondary Outcomes (1)

  • Efficacy of NK DLI Infusions

    5 years after last NK DLI

Study Arms (1)

NK cell DLI

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

Interventions

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

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)

NK cell DLI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätsklinikum

Frankfurt, Germany

Location

University Hospital

Basel, Switzerland

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaMyelodysplastic SyndromesLymphomaNeuroblastomaRhabdomyosarcoma

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBone Marrow DiseasesNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueMyosarcomaNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueSarcoma

Study Officials

  • Jakob Passweg, MD

    University Hospital, Basel, Switzerland

    STUDY CHAIR

  • Dirk Schwabe, MD

    Johann Wolfgang Goethe University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2011

First Posted

July 1, 2011

Study Start

January 1, 2004

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

March 19, 2024

Record last verified: 2024-03

Locations

DE(1)CH(1)