Recruiting PHASE1, PHASE2 Acute Myeloid Leukemia

New treatment option for Acute Myeloid Leukemia

Official title Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Children/Young Adults With AML

ClinicalTrials.gov ID: NCT05272293

What this study is testing

What is NK cell infusions?

NK cell infusions is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells for children/young adults with primary high risk or refractory AML and relapsed AML.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 6 to 30

You may be able to join if

  • Patients:
  • primary high risk AML
  • primary refractory AML
  • relapsed AML
  • Karnofsky or Lansky performance scale greater or equal to 70

You likely can't join if

  • Patients:
  • uncontrolled infection
  • severe hepatic dysfunction: SGOT or SCPT \>=5x upper limit of normal for age
  • positive serology for human immunodeficiency virus (HIV) Donors:
  • pregnancy
  • positive serology for HIV, hepatitis B or C
See the full eligibility criteria
Who can join
  • Patients:
  • primary high risk AML
  • primary refractory AML
  • relapsed AML
  • Karnofsky or Lansky performance scale greater or equal to 70
  • written informed consent Donors:
  • haploidentical family donor
  • donor suitable for cell donation and apheresis according to standard criteria
  • written informed consent
What rules you out
  • Patients:
  • uncontrolled infection
  • severe hepatic dysfunction: SGOT or SCPT \>=5x upper limit of normal for age
  • positive serology for human immunodeficiency virus (HIV) Donors:
  • pregnancy
  • positive serology for HIV, hepatitis B or C

The study team makes the final eligibility decision.

Where it's taking place

  • Minsk, Minsk Oblast, Belarus

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 6 months to 30 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Minsk, Minsk Oblast, Belarus. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.