Haploidentical Stem Cell Transplant With or Without NK Cell Infusion in AML and MDS

Acute Myeloid Leukemia Clinical Trial

— Bigeminy  

Official title:

Haploidentical Stem Cell Transplantation With or Without NK Cell Infusion in Refractory/Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndrome:The BigEMINy Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04166929
• Other study ID #: 2588
• Status: Terminated
• Phase: Phase 2
• Start date: January 15, 2020
• Est. completion date: September 28, 2023

Study information

• Verified date: May 2021
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Relapse after an allogeneic hematopoietic stem cell transplantation (HSCT) is high in patients with advanced AML, in the 50% range. NK cells have been shown to possess significant anti-leukemic activity and may be used to reduce the incidence of relapse in patients with advanced AML.

Investigators hypothesize that the administration of a purified boost of NK cells on day +7 post HSCT, will reduce the incidence of relapse from the current 50% to 25%. In a phase III multicenter clinical study, 116 patients will be randomized to receive or not a boost of donor NK cells on day +7 post-HSCT. The first 10 patients in the experimental arm will be analyzed for toxicity. The stopping rule will be a transplant related mortality of more than 50% in the first 20 patients who received NK cells.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 28, 2023
• Est. primary completion date: September 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of AML or MDS

• Patients not in remission at the time of transplant

• Age 18-75

• ECOG performance status <2

• Availability of a family HLA haploidentical donor, eligible to donate both marrow cells and unstimulated lymphocytes (1 apheresis procedure at day +7) .

Exclusion Criteria:

• Positive serologic markers for human immunodeficiency virus (HIV)

• Acute hepatitis B virus (HBV) or acute hepatitis C virus (HCV) infection

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplasia
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Biological:
• Haplo SCT with NK cells
Patients in this arm receive haplo-SCT followed by one boost of NK cells one/two weeks after the transplant. Lymphocyte are collected by apheresis from the donor one-two weeks after BM harvest. CD3 negative/CD56 positive cells are selected by immunomagnetic columns (other lymphocytes are stored to be used as DLI)
• Haplo SCT
Patients in this arm receive a standard haplo-SCT. All administerd therapies are the same as in other arm, except for the NK cell boost..

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma	RM

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Ministry of Health, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leukemia relapse	Cumulative incidence of leukemia relapse.	1 year after bone marrow transplant