Expanded Natural Killer Cells Following Haploidentical HSCT for AML/MDS

Phase 1

Recruiting

• Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndromes

• Registration Number: NCT03300492
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-30
• Study First Submitted QC: 2017-10-02
• Study First Posted: 2017-10-03
• Study Start: 2018-11-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29
• Primary Completion: 2025-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events including GvHD and infections.	1 year following haplo HSCT	As defined by the CTCAE version 4.03 and the NIH Scoring of GvHD.

Secondary Outcome Measures

Name	Time	Method
Incidence of graft rejection	1 year following haplo HSCT
Number of NK cells given per kg body weight	30 days following haplo-HSCT
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	1 year following haplo HSCT	rejection.
Number of NK-DLI infusions applied	30 days following haplo-HSCT

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland