Cord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia

March 25, 2020 updated by: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Discuss the effectiveness and safety of cord blood microtransplantation for treatment of acute myeloid leukemia

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators conducted a prospective, single center clinical trial to dissuss the outcomes and toxicities of HLA-mismatched cord blood infusion after chemotherapy (microtransplantation) in older patients with acute myeloid leukemia (AML)

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Hefei, China, 230001
        • Recruiting
        • The First Affiliated hospital of USTC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. de novo acute myeloid leukemia
  2. age 60-80

Exclusion Criteria:

  1. have no suitable donor or donor refused
  2. patient refused to accept donor cells

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cord blood group
standard induction and consolidation chemotherapy with cord blood microtransplantation
Biological: microtransplantation
HLA mismatched donor cord blood infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete remission rate
Time Frame: 1 month
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
Time Frame: 1 month
Absolute neutrophil count >500/mcL; Platelets ≥20,000/mcL
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to progression
Time Frame: 2 year
Measured from complete remission to the relapse
2 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
diease free survival
Time Frame: 2 year
Measured from complete remission to the date of death or the date of last follow-up examination.
2 year
overall survival
Time Frame: 2 year
Measured from the date of beginning therapy to the date of death or the date of last follow-up examination.
2 year
rate of early mortality
Time Frame: 1 month
Death within 4 weeks after initiation of induction therapy
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Investigators

  • Study Chair: Zimin Sun, The First Affiliated hospital of USTC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2020

Primary Completion (Anticipated)

August 31, 2024

Study Completion (Anticipated)

August 31, 2024

Study Registration Dates

First Submitted

October 14, 2019

First Submitted That Met QC Criteria

November 21, 2019

First Posted (Actual)

November 22, 2019

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CB-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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