Efectiveness of Donor IL-15-stimulated NK Cells Post Transplant Infusion in in Acute Leukemia

ACUTE LEUKEMIA Clinical Trial

Official title:

Fase I/II, Unicentric, Historical Control Clinical Trial to Evaluate the Effectiveness of Donor IL-15 Stimulated NK Cells Post Transplant Infusion, in Acute Leukemia Patients With Poor Prognosis and Haploidentical Unmanipulated Transplant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669172
• Other study ID #: EC-HEM-HGUGM-2016-01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 2, 2017
• Est. completion date: July 6, 2021

Study information

• Verified date: September 2021
• Source: Martín, José Luis Díez, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical trial phase I and II, single-center, historical control, to evaluate the effectiveness of donor IL-15 stimulated NK cells post transplant infusion, in acute leukemia patients with poor prognosis and haploidentical unmanipulated transplant

Description:

This clinical trial wants to study the safety, effectiveness and efficacy of NK cells incubated infusion (CD56 +, CD3) incubated ex vivo with IL-15 infusion in patients with high risk acute myeloid leukemia undergoing allogeneic transplant of an haploidentical donor with post-transplant cyclophosphamide administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 6, 2021
• Est. primary completion date: July 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. More than 18 years old, with acute myeloid leukemia who goes to undergo haploidentical

2. Assessable disease by analytic, molecular or image techniques.

3. Comorbidity Sorror index less than 6.

4. Give informed consent according to the legal requirements.

5. Dispose of a donor without exclusion criteria.

Exclusion Criteria:

1. Positive HIV serology.

2. Patients with an active infection or other underlying serious medical statement.

3. Any medical process, analytical abnormality or important psychiatric disorder, according to the investigator's opinion, that prevent the participation of the patient in the study.

4. Participation of any other interventional clincal trial within 30 days of planned enrollment into this study.

5. Women who are pregnant or breastfeeding.

Related Conditions & MeSH terms

• Acute Disease
• ACUTE LEUKEMIA
• Leukemia

Intervention

Biological:
• Donor IL-15 stimulated NK cells infusion
DONOR IL-15-STIMULATED NK CELLS POST TRANSPLANT INFUSION, IN ACUTE LEUKEMIA PATIENTS WITH POOR PROGNOSIS AND HAPLOIDENTICAL UNMANIPULATED TRANSPLANT

Locations

Country	Name	City	State
Spain	Hospital General Universitario Gregorio Marañón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Martín, José Luis Díez, M.D.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0	Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0	Up to 2 years after first infusion
Secondary	Reevaluation of the Minimal residual disease (MRD)	Reevaluation of the Minimal residual disease (MRD) in bone marrow by flow cytometry	Up to 1 year after first infusion