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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NK-DLI | Experimental | Preemptive immunotherapy with ex vivo expanded NK cells on days +10, +15 and +20 with increasing NK cell doses following haplo-HSCT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NK-DLI | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events including GvHD and infections. | As defined by the CTCAE version 4.03 and the NIH Scoring of GvHD. | 1 year following haplo HSCT |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | 1 year following haplo HSCT | |
| Incidence of AML/MDS-EB complete morphological and molecular remission (CR) at day + 30, + 90, +180 and 1 year post allo-HSCT | rejection. |
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Inclusion Criteria:
Patient:
Donor:
Exclusion Criteria:
Patient:
Exclusion Criteria:
Donor:
• Pregnancy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matyas Ecsedi, MD-PhD | Contact | +41612652525 | matyas.ecsedi@usb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Jakob Passweg, Prof. MD | University Hospital Basel, Basel Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Recruiting | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Prospective, single center, open-label, single arm study
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| 1 year following haplo HSCT |
| Incidence of graft rejection | 1 year following haplo HSCT |
| Number of NK cells given per kg body weight | 30 days following haplo-HSCT |
| Number of NK-DLI infusions applied | 30 days following haplo-HSCT |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |