NK DLI in Patients After HLA-haploidentical HSCT

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT01386619

First received: June 7, 2011

Last updated: January 18, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 7, 2011

Last Updated Date

January 18, 2013

Start Date ^ICMJE

January 2004

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Feasibility of NK-DLI production [ Time Frame: At day of transplant (day 0) ] [ Designated as safety issue: No ]
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+/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 [ Time Frame: Day +60 after transplant ] [ Designated as safety issue: Yes ]
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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01386619 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Efficacy of NK DLI Infusions [ Time Frame: 5 years after last NK DLI ] [ Designated as safety issue: No ]

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

NK DLI in Patients After HLA-haploidentical HSCT

Official Title ^ICMJE

Natural Killer Cell Selected T-cell Depleted Donor Lymphocyte Infusions (NK-DLI) in Patients After HLA-haploidentical Allogeneic Stem Cell Transplantation

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

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

NK DLI products containing >1 10e7 NK cells/kg BW and < 1 x 10e5 T-cells/kg BW are administered at days +4 (Frankfurt only), and on days +40 and +100 (both centers)

Study Arm (s)

Experimental: NK cell DLI

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 GvHD

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany, Switzerland

Administrative Information

NCT Number ^ICMJE

NCT01386619

Other Study ID Numbers ^ICMJE

NK-DLI Allo-Tx

Has Data Monitoring Committee

Responsible Party

University Hospital, Basel, Switzerland

Study Sponsor ^ICMJE

University Hospital, Basel, Switzerland

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:	Jakob Passweg, MD	University Hospital, Basel, Switzerland
Study Chair:	Dirk Schwabe, MD	Universitätsklinikum Frankfurt

Information Provided By

University Hospital, Basel, Switzerland

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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