Back to resultsCord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia
Primary Purpose
Safety Issues, Efficiency
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
microtransplantation
Sponsored by
About this trial
This is an interventional treatment trial for Safety Issues focused on measuring Cord blood microtransplatation
Eligibility Criteria
Inclusion Criteria:
- de novo acute myeloid leukemia
- age 60-80
Exclusion Criteria:
- have no suitable donor or donor refused
- patient refused to accept donor cells
Sites / Locations
- The First Affiliated Hospital of USTCRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cord blood group
Arm Description
standard induction and consolidation chemotherapy with cord blood microtransplantation
Outcomes
Primary Outcome Measures
complete remission rate
Bone marrow <5% blasts； Absolute neutrophil count >1000/mcL； Platelets ≥100,000/mcL；No residual evidence of extramedullary disease.
time of hematopoietic recovery
Absolute neutrophil count >500/mcL; Platelets ≥20,000/mcL
Secondary Outcome Measures
time to progression
Measured from complete remission to the relapse
Full Information
NCT ID
NCT04174586
First Posted
October 14, 2019
Last Updated
March 25, 2020
Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04174586
Brief Title
Cord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia
Official Title
Cord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Discuss the effectiveness and safety of cord blood microtransplantation for treatment of acute myeloid leukemia
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety Issues, Efficiency
Keywords
Cord blood microtransplatation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cord blood group
Arm Type
Experimental
Arm Description
standard induction and consolidation chemotherapy with cord blood microtransplantation
Intervention Type
Biological
Intervention Name(s)
microtransplantation
Intervention Description
HLA mismatched donor cord blood infusion
Primary Outcome Measure Information:
Title
complete remission rate
Description
Bone marrow <5% blasts； Absolute neutrophil count >1000/mcL； Platelets ≥100,000/mcL；No residual evidence of extramedullary disease.
Time Frame
1 month
Title
time of hematopoietic recovery
Description
Absolute neutrophil count >500/mcL; Platelets ≥20,000/mcL
Time Frame
1 month
Secondary Outcome Measure Information:
Title
time to progression
Description
Measured from complete remission to the relapse
Time Frame
2 year
Other Pre-specified Outcome Measures:
Title
diease free survival
Description
Measured from complete remission to the date of death or the date of last follow-up examination.
Time Frame
2 year
Title
overall survival
Description
Measured from the date of beginning therapy to the date of death or the date of last follow-up examination.
Time Frame
2 year
Title
rate of early mortality
Description
Death within 4 weeks after initiation of induction therapy
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
de novo acute myeloid leukemia
age 60-80
Exclusion Criteria:
have no suitable donor or donor refused
patient refused to accept donor cells
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen Yao
Phone
055162283730
Ext
055162283730
Email
yaowen0511@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zimin Sun
Organizational Affiliation
The First Affiliated Hospital of USTC
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital of USTC
City
Hefei
ZIP/Postal Code
230001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Yao
Phone
055162283730
Ext
055162283730
Email
yaowen0511@163.com
12. IPD Sharing Statement
Learn more about this trial
Cord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia
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