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Randomized Study of Haploidentical Hct and Subsequent Donor nk Cell Infusion in High-risk AML and MDS

NCT02477787 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2019-07-08

No results posted yet for this study

Summary

This is a single center, open label, random comparison phase 2b study. The primary objective of this study is, by random comparison, to assess the anti-leukemia effect of allogeneic, donor-derived natural killer (NK) cells infused after HLA-haploidentical hematopoietic cell transplantation (HCT) in patients with refractory acute myelogenous leukemia (AML).

The secondary objectives of the study are to assess the side effects of donor NK cell infusion, effects of donor NK cell infusion upon HCT outcomes, as well as effects upon post-HCT immune recovery.

Conditions

  • Acute Myelogenous Leukemia

Interventions

BIOLOGICAL

allogeneic, donor-derived NK cells

Patients in the study arm will receive donor NK cell infusion around days 13 and 20. A permissible range of infusion time will be +/- 3 days. For DNKI to be given on day 13 (DNKI-1), the cell dose is 1-2 x108/kg or about the half of amount generated. For DNKI to be given on day 20 (DNKI-2), the cell dose is up to 5x108/kg. Avil 1 ampoule will be given intravenously 30 minutes prior to each NK cell infusions.

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02477787 on ClinicalTrials.gov