NCT02831192

Brief Summary

The purpose of this study is to see whether HLA-mismatched donor cells infusion with chemotherapy (microtransplantation，MST) could increase complete remission (CR) and improve survival in older patients with acute myeloid leukemia (AML)，the investigators conducted a prospective, multicenter clinical trial of HLA-mismatched MST to estimate outcomes and toxicities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2006

Longer than P75 for phase_2

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

May 1, 2006

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 3, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
Last Updated

July 13, 2016

Status Verified

July 1, 2016

Enrollment Period

9.2 years

First QC Date

July 3, 2016

Last Update Submit

July 12, 2016

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Graft versus host disease

    1 month

Secondary Outcomes (3)

  • overall survival

    2 years

  • leukemia free survival

    2 years

  • complete remission rate

    2 months

Study Arms (1)

MST（microtransplantation）

EXPERIMENTAL
Biological: microtransplantation

Interventions

microtransplantationBIOLOGICAL

HLA mismatched donor mobilized prepheral stem cell infusion

MST（microtransplantation）

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • de novo acute myeloid leukemia
  • age 60-90
  • have HLA mismatched donor

You may not qualify if:

  • have no suitable donor or donor refused
  • patient refused to accept donor cells

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

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • AI huisheng, MD

    Affiliated Hospital of Academy of Military Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2016

First Posted

July 13, 2016

Study Start

May 1, 2006

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 13, 2016

Record last verified: 2016-07

Locations

CN(1)