NCT03759899

Brief Summary

hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 19, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 30, 2018

Completed
1.6 years until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

October 1, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

November 19, 2018

Last Update Submit

September 30, 2020

Conditions

Leukemia

Outcome Measures

Primary Outcomes (1)

  • Cell counts of T cells, NK cells, B cells and monocytes

    proliferation and apoptosis of T cells, NK cells, B cells and monocytes in peripheral blood of patients

    Day 7

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

leukemia patients with allogeneic HSCT

You may qualify if:

  • leukemia patients with allogeneic HSCT
  • KFS score \>90
  • after transplantation, the patient was implanted (peripheral blood neutrophil absolute value \>500/ul for 3 consecutive days)
  • no uncontrolled infection after transplantation
  • activity II above aGVHD
  • patients agreed to participate in the study

You may not qualify if:

  • patients refused to participate in the study
  • patients have poor compliance
  • has received hormone therapy
  • patients had serious heart, lung, liver, kidney and other vital organs damage
  • researchers believe that patients who are not suitable for observation study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Institute of Hematology

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Xiaojun Huang

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

xiangyu Zhao

CONTACT

010-88325949zhao_xy@bjmu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Hematology Department

Study Record Dates

First Submitted

November 19, 2018

First Posted

November 30, 2018

Study Start

July 1, 2020

Primary Completion

July 1, 2021

Study Completion

July 1, 2022

Last Updated

October 1, 2020

Record last verified: 2020-09

Locations

CN(1)