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Cord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT04174586
Recruitment Status : Recruiting
First Posted : November 22, 2019
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Tracking Information
First Submitted Date  ICMJE October 14, 2019
First Posted Date  ICMJE November 22, 2019
Last Update Posted Date March 26, 2020
Actual Study Start Date  ICMJE January 22, 2020
Estimated Primary Completion Date August 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2019)
  • 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.
  • time of hematopoietic recovery [ Time Frame: 1 month ]
    Absolute neutrophil count >500/mcL; Platelets ≥20,000/mcL
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2019)		 time to progression [ Time Frame: 2 year ]
Measured from complete remission to the relapse
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 21, 2019)
  • diease free survival [ Time Frame: 2 year ]
    Measured from complete remission to the date of death or the date of last follow-up examination.
  • 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.
  • rate of early mortality [ Time Frame: 1 month ]
    Death within 4 weeks after initiation of induction therapy
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Cord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia
Official Title  ICMJE Cord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia
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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Safety Issues
  • Efficiency
Intervention  ICMJE Biological: microtransplantation
HLA mismatched donor cord blood infusion
Study Arms  ICMJE Experimental: cord blood group
standard induction and consolidation chemotherapy with cord blood microtransplantation
Intervention: Biological: microtransplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 21, 2019)		 20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2024
Estimated Primary Completion Date August 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wen Yao 055162283730 ext 055162283730 yaowen0511@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04174586
Other Study ID Numbers  ICMJE CB-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Study Sponsor  ICMJE The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Zimin Sun The First Affiliated Hospital of USTC
PRS Account The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP