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Cord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
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Brief Summary:
Discuss the effectiveness and safety of cord blood microtransplantation for treatment of acute myeloid leukemia

Condition or disease Intervention/treatment Phase
Safety Issues Efficiency Biological: microtransplantation Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia
Actual Study Start Date : January 22, 2020
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: cord blood group
standard induction and consolidation chemotherapy with cord blood microtransplantation
 Biological: microtransplantation
HLA mismatched donor cord blood infusion


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. time of hematopoietic recovery [ Time Frame: 1 month ]
    Absolute neutrophil count >500/mcL; Platelets ≥20,000/mcL


Secondary Outcome Measures :
  1. time to progression [ Time Frame: 2 year ]
    Measured from complete remission to the relapse


Other Outcome Measures:
  1. 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. 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.

  3. rate of early mortality [ Time Frame: 1 month ]
    Death within 4 weeks after initiation of induction therapy


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04174586


Contacts
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Contact: Wen Yao 055162283730 ext 055162283730 yaowen0511@163.com

Locations
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China
The First Affiliated Hospital of USTC Recruiting
Hefei, China, 230001
Contact: Wen Yao    055162283730 ext 055162283730    yaowen0511@163.com   
Sponsors and Collaborators
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Investigators
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Study Chair: Zimin Sun The First Affiliated Hospital of USTC
More Information
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Responsible Party: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT04174586    
Other Study ID Numbers: CB-001
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences:
Cord blood microtransplatation
Additional relevant MeSH terms:
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Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid