Back to resultsEfectiveness of Donor IL-15-stimulated NK Cells Post Transplant Infusion in in Acute Leukemia
Primary Purpose
ACUTE LEUKEMIA
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Donor IL-15 stimulated NK cells infusion
Sponsored by
About this trial
This is an interventional treatment trial for ACUTE LEUKEMIA
Eligibility Criteria
Inclusion Criteria:
- More than 18 years old, with acute myeloid leukemia who goes to undergo haploidentical
- Assessable disease by analytic, molecular or image techniques.
- Comorbidity Sorror index less than 6.
- Give informed consent according to the legal requirements.
- Dispose of a donor without exclusion criteria.
Exclusion Criteria:
- Positive HIV serology.
- Patients with an active infection or other underlying serious medical statement.
- 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.
- Participation of any other interventional clincal trial within 30 days of planned enrollment into this study.
- Women who are pregnant or breastfeeding.
Sites / Locations
- Hospital General Universitario Gregorio Marañón
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NK cells infusion
Arm Description
NK cells incubated infusion (CD56 +, CD3) ex vivo with IL-15 in patients with acute myeloid leukemia undergoing high-risk allogeneic haploidentical Pt-C donor
Outcomes
Primary Outcome Measures
Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Secondary Outcome Measures
Reevaluation of the Minimal residual disease (MRD)
Reevaluation of the Minimal residual disease (MRD) in bone marrow by flow cytometry
Full Information
NCT ID
NCT03669172
First Posted
March 6, 2018
Last Updated
September 2, 2021
Sponsor
Martín, José Luis Díez, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT03669172
Brief Title
Efectiveness of Donor IL-15-stimulated NK Cells Post Transplant Infusion in in Acute Leukemia
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 2, 2017 (Actual)
Primary Completion Date
July 6, 2021 (Actual)
Study Completion Date
July 6, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Martín, José Luis Díez, M.D.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACUTE LEUKEMIA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NK cells infusion
Arm Type
Experimental
Arm Description
NK cells incubated infusion (CD56 +, CD3) ex vivo with IL-15 in patients with acute myeloid leukemia undergoing high-risk allogeneic haploidentical Pt-C donor
Intervention Type
Biological
Intervention Name(s)
Donor IL-15 stimulated NK cells infusion
Intervention Description
DONOR IL-15-STIMULATED NK CELLS POST TRANSPLANT INFUSION, IN ACUTE LEUKEMIA PATIENTS WITH POOR PROGNOSIS AND HAPLOIDENTICAL UNMANIPULATED TRANSPLANT
Primary Outcome Measure Information:
Title
Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Description
Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time Frame
Up to 2 years after first infusion
Secondary Outcome Measure Information:
Title
Reevaluation of the Minimal residual disease (MRD)
Description
Reevaluation of the Minimal residual disease (MRD) in bone marrow by flow cytometry
Time Frame
Up to 1 year after first infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
More than 18 years old, with acute myeloid leukemia who goes to undergo haploidentical
Assessable disease by analytic, molecular or image techniques.
Comorbidity Sorror index less than 6.
Give informed consent according to the legal requirements.
Dispose of a donor without exclusion criteria.
Exclusion Criteria:
Positive HIV serology.
Patients with an active infection or other underlying serious medical statement.
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.
Participation of any other interventional clincal trial within 30 days of planned enrollment into this study.
Women who are pregnant or breastfeeding.
Facility Information:
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efectiveness of Donor IL-15-stimulated NK Cells Post Transplant Infusion in in Acute Leukemia
We'll reach out to this number within 24 hrs