NCT03669172

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2021

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

3.7 years

First QC Date

March 6, 2018

Last Update Submit

September 2, 2021

Conditions

ACUTE LEUKEMIA

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Reevaluation of the Minimal residual disease (MRD)

    Up to 1 year after first infusion

Study Arms (1)

NK cells infusion

EXPERIMENTAL

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

Biological: Donor IL-15 stimulated NK cells infusion

Interventions

Donor IL-15 stimulated NK cells infusionBIOLOGICAL

DONOR IL-15-STIMULATED NK CELLS POST TRANSPLANT INFUSION, IN ACUTE LEUKEMIA PATIENTS WITH POOR PROGNOSIS AND HAPLOIDENTICAL UNMANIPULATED TRANSPLANT

NK cells infusion

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2018

First Posted

September 13, 2018

Study Start

November 2, 2017

Primary Completion

July 6, 2021

Study Completion

July 6, 2021

Last Updated

September 5, 2021

Record last verified: 2021-09

Locations

ES(1)