NCT04174586

Brief Summary

Discuss the effectiveness and safety of cord blood microtransplantation for treatment of acute myeloid leukemia

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
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2020

Longer than P75 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

First Submitted

Initial submission to the registry

October 14, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 22, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 22, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

4.6 years

First QC Date

October 14, 2019

Last Update Submit

March 25, 2020

Conditions

Safety IssuesEfficiency

Keywords

Cord blood microtransplatation

Outcome Measures

Primary Outcomes (2)

  • complete remission rate

    Bone marrow \<5% blasts； Absolute neutrophil count \>1000/mcL； Platelets ≥100,000/mcL；No residual evidence of extramedullary disease.

    1 month

  • time of hematopoietic recovery

    Absolute neutrophil count \>500/mcL; Platelets ≥20,000/mcL

    1 month

Secondary Outcomes (1)

  • time to progression

    2 year

Other Outcomes (3)

  • diease free survival

    2 year

  • overall survival

    2 year

  • rate of early mortality

    1 month

Study Arms (1)

cord blood group

EXPERIMENTAL

standard induction and consolidation chemotherapy with cord blood microtransplantation

Biological: microtransplantation

Interventions

microtransplantationBIOLOGICAL

HLA mismatched donor cord blood infusion

cord blood group

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • de novo acute myeloid leukemia
  • age 60-80

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)

The First Affiliated Hospital of USTC

Hefei, 230001, China

RECRUITING

Study Officials

  • Zimin Sun

    The First Affiliated Hospital of USTC

    STUDY CHAIR

Central Study Contacts

Wen Yao

CONTACT

055162283730yaowen0511@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

October 14, 2019

First Posted

November 22, 2019

Study Start

January 22, 2020

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

March 26, 2020

Record last verified: 2020-03

Locations

CN(1)