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NCT Number: NCT03300492

Expanded Natural Killer Cells Following Haploidentical HSCT for AML/MDS

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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Key information

Conditions

Acute Myeloid Leukemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Location status: Recruiting

Location contact

Matyas Ecsedi, MD-PhD

CONTACT

[email protected]

+41612652525

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Matyas Ecsedi, MD-PhD

CONTACT

[email protected]

+41612652525

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Oct 3, 2017
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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