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Recruiting NCT03300492

Expanded Natural Killer Cells Following Haploidentical HSCT for AML/MDS

Phase I / Phase II Interventional Acute Myeloid Leukemia Myelodysplastic Syndromes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NK-DLI.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase I/II Single Center Study to Assess the Safety, Tolerability and Feasibility of Pre-emptive Immunotherapy With in Vitro Expanded Natural Killer Cells in Patients Treated With Haplo-HSCT for AML/MDS

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

  • Incidence and severity of adverse events including GvHD and infections. [Time frame: 1 year following haplo HSCT]
Secondary outcome measures (5)
  • Progression-free survival (PFS) [Time frame: 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 [Time frame: 1 year following haplo HSCT]
  • Incidence of graft rejection [Time frame: 1 year following haplo HSCT]
  • Number of NK cells given per kg body weight [Time frame: 30 days following haplo-HSCT]
  • Number of NK-DLI infusions applied [Time frame: 30 days following haplo-HSCT]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • University Hospital Basel — Basel

Identifiers

NCT: NCT03300492 · Haplo-NK-DLI for AML/MDS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗