JOURNAL ONKOLOGIE – STUDIE

Expanded Natural Killer Cells Following Haploidentical HSCT for AML/MDS

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT03300492

Studienbeginn:
November 2018

Letztes Update:
29.11.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Myelodysplastic Syndromes

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital, Basel, Switzerland

Collaborator:
-

Studienleiter

Jakob Passweg, Prof. MD
Principal Investigator
University Hospital Basel, Basel Switzerland

Kontakt

Matyas Ecsedi, MD-PhD
Kontakt:
Phone: +41612652525
E-Mail: matyas.ecsedi@usb.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital Basel
4031 Basel
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Matyas Ecsedi, MD-PhD
Phone: +41612652525
E-Mail: matyas.ecsedi@usb.ch» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

The study examines the application of expanded natural killer cells (NK cells) following

haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) for AML or

MDS. Haplo-HSCT is a preferred treatment option for patients with AML or MDS without a

HLA-matched donor. With administration of cyclophosphamide post-transplant , the safety of

the procedure is similar to a HSCT from a HLA-identical donor. Relapse of AML/MDS represents

a serious problem following haplo-HSCT. NK cells are immune cells able to destroy tumor

cells. Their potency has been established particularly in the setting of a haplo-HSCT. In the

current study, study participants undergoing haplo-HSCT will receive expanded NK cells from

their respective stem-cell donors following haplo-HSCT. The primary goal of the study is to

establish the safety and feasibility of this approach. In addition, the activity of the NK

cells will be examined.

Ein-/Ausschlusskriterien

Inclusion Criteria:

Patient:

- >18 years of age

- No HLA-matched related or unrelated donor available

- AML or MDS-EB with indication for a haplo-HSCT according to the guidelines of the

University Hospital Basel Stem Cell Transplant Team

- Judged by the transplant physicians to have adequate organ function and no

contraindications to haplo-HSCT

- Available related haploidentical donor

- Written informed consent

Donor:

- >18 years old, haploidentical parent, sibling or other relative

- Donor suitable for cell donation and apheresis according to standard criteria

- Written informed consent

Exclusion Criteria:

Patient:

- APL diagnosis

- Presence of relevant (mean fluorescence intensity >2000) donor-specific anti-HLA

antibodies

- Pregnancy

- Necessity of immunosuppression apart from GvHD prophylaxis

Exclusion Criteria:

Donor:

• Pregnancy

Studien-Rationale

Primary outcome:

1. Incidence and severity of adverse events including GvHD and infections. (Time Frame - 1 year following haplo HSCT):
As defined by the CTCAE version 4.03 and the NIH Scoring of GvHD.

Secondary outcome:

1. Progression-free survival (PFS) (Time Frame - 1 year following haplo HSCT)

2. Incidence of AML/MDS-EB complete morphological and molecular remission (CR) at day + 30, + 90, +180 and 1 year post allo-HSCT (Time Frame - 1 year following haplo HSCT):
rejection.

3. Incidence of graft rejection (Time Frame - 1 year following haplo HSCT)

4. Number of NK cells given per kg body weight (Time Frame - 30 days following haplo-HSCT)

5. Number of NK-DLI infusions applied (Time Frame - 30 days following haplo-HSCT)

Geprüfte Regime

NK-DLI:
Application of three infusions of ex vivo expanded NK cells on days +10, +15 and +20 with increasing NK cell doses (1x107/kg, 1x108/kg and the remaining cells up to 1x109/kg) following haplo-HSCT. Maximal cumulative T-cell dose is fixed at <1x105/kg.

Quelle: ClinicalTrials.gov

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