NCT03080922

Brief Summary

The purpose of this study is to evaluate the safety and efficiency of high dose allogeneic mismatched hematopoietic stem cells infusions after normal chemotherapy in patients with relapsed/refractory acute myeloid leukemia（AML）.

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
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2016

Typical duration for phase_1

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

Study Start

First participant enrolled

March 1, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 10, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

March 10, 2017

Last Update Submit

March 30, 2017

Conditions

Leukemia, Myeloid

Keywords

Acute Myeloid LeukemiaRelapsedRefractoryhematopoietic stem cell

Outcome Measures

Primary Outcomes (1)

  • complete remission rate

    2 months

Secondary Outcomes (4)

  • Disease-free survival

    2 years

  • Overall survival

    2 years

  • donor graft rate

    6 months

  • Occurrence of study related adverse events

    6 months

Study Arms (1)

hematopoietic stem cell

EXPERIMENTAL

high dose of donor granulocyte colony-stimulating factor（G-CSF）mobilized peripheral blood hematopoietic stem cell are infused to patient received normal chemotherapy

Biological: hematopoietic stem cell

Interventions

hematopoietic stem cellBIOLOGICAL

high dose of donor G-CSF mobilized peripheral blood hematopoietic stem cell are infused to patient received normal chemotherapy

hematopoietic stem cell

Eligibility Criteria

Age15 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with relapsed and/or refractory AML
  • Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

You may not qualify if:

  • Previous treatment with investigational gene or cell therapy medicine products
  • Any uncontrolled active medical disorder that would preclude participation as outlined

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Academy of Military Medical Sciences ,

Beijing, Beijing Municipality, 100071, China

RECRUITING

MeSH Terms

Conditions

Leukemia, MyeloidLeukemia, Myeloid, AcuteRecurrence

Condition Hierarchy (Ancestors)

LeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • HUISHENG AI

    Affiliated Hospital of Academy of Military Medical Sciences

    STUDY CHAIR

Central Study Contacts

HUISHENG AI

CONTACT

HUISHNGAI@163.COM

Study Design

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

Study Record Dates

First Submitted

March 10, 2017

First Posted

March 15, 2017

Study Start

March 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2019

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

CN(1)