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Umbilical Cord Blood Transfusion in Consolidation Therapy of Elderly Patients With Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT04687657
Recruitment Status : Recruiting
First Posted : December 29, 2020
Last Update Posted : August 24, 2021
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Study Description
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Brief Summary:
After complete remission, elderly AML patients cannot tolerate hematopoietic stem cell transplantation and standard-dose consolidation chemotherapy, and the 5-year survival rate is around 10%. Therefore, it is necessary to explore treatment strategy that can support chemotherapy or improve immunity. Umbilical cord blood is rich in hematopoietic stem cells and immune cells. However,Cord blood transplantation for adults is still being explored. The application of cord blood in supportive treatment can be actively explored. Cord blood has low immunogenicity and is unlikely to cause Graft versus host disease (GVHD), and the infusion is relatively safe. The Department of Hematology of Shanghai Ruijin Hospital has conducted a related phase II clinical study, and found that cord blood transfusion reduced the chance of infection and increased the 2-year survival. Our subject is a prospective single-arm clinical study. It is planned to recruit 20 elderly AML patients to explore whether the application of cord blood infusion can further improve the prognosis of patients during their consolidation chemotherapy.

Condition or disease Intervention/treatment Phase
Leukemia, Myelomonocytic, Acute Drug: umbilical cord blood Phase 1

Detailed Description:
20 elderly AML patients who achieved complete remission (CR) after induction chemotherapy will be enrolled in this study. Baseline data are collected and informed consents are signed before consolidation chemotherapy. At the same time, HLA typing test is carried out, and the corresponding cord blood is matched from the cord blood bank. During the consolidation chemotherapy stage, the cord blood transfusion is given twice (interval of 1 month) to support treatment. On the first day after umbilical cord blood transfusion, the proportion of NK cells in peripheral blood are detected. If it is less than 20%, the NK cells are activated by subcutaneous injection of recombinant human interleukin-2 (rhIL-2) on the second day after infusion. The treatment effects are continuously monitored and followed up regularly after treatment.The intend of this trial is to explore whether cord blood transfusion in the consolidation phase can further reduce the recurrence rate of AML and improve prognosis.
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: Application of Umbilical Cord Blood Transfusion in Consolidation Therapy of Elderly Patients With Acute Myeloid Leukemia
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : February 28, 2024
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: cord blood transfusion
The arm that will receive the target treatment.
 Drug: umbilical cord blood
During the consolidation chemotherapy stage, the umbilical cord blood transfusion is given twice (interval of 1 month) to support treatment. On the first day after umbilical cord blood transfusion, the proportion of NK cells in peripheral blood is detected. If it is less than 20%, the NK cells sre activated by subcutaneous injection of recombinant human interleukin-2 (rhIL-2) on the second day after infusion.
Other Name: cord blood


Outcome Measures
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Primary Outcome Measures :
  1. 2-year Overall survival [ Time Frame: 2-years ]
    the overall survival rate of enrolled patients at the end of 2 years


Secondary Outcome Measures :
  1. 2-year Disease-free survival [ Time Frame: 2-years ]
    DFS is measured from the date when CR is achieved. And the end includes death or relapse.


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

Inclusion Criteria:

  • Age ≥60 years
  • Patients with primary AML diagnosed in accordance with the "Adult Acute Myeloid Leukemia (Non-Acute Promyelocytic Leukemia) Chinese Diagnosis and Treatment Guidelines (2017 Edition)", who achieved CR after induction chemotherapy
  • Normal heart function , Ejection fraction ≥ 50%
  • Normal liver function with ALT and AST ≤ 2.5 times the upper limit of normal value, bilirubin ≤ 2 times the upper limit of normal value
  • Normal kidney function with blood creatinine ≤ 3.0 mg/dL (≤ 260 µmol/L)
  • Voluntarily signed an informed consent.

Exclusion Criteria:

  • Combined with severe infection
  • Combined with other malignant tumors
  • Other patients deemed unsuitable to be tested by the investigator
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): NCT04687657


Contacts
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Contact: huaiyu Wang, doctor 0086-18991232410 whymed@126.com
Contact: sha Gong, doctor 0086-18710720955 314621649@qq.com

Locations
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China, Shanxi
The first affiliated hospital of Xi'an jiaotong university Recruiting
Xi'an, Shanxi, China, 710061
Contact: huaiyu Wang    085-18991232410      
Xi'anJiaotong University Not yet recruiting
Xi'an, Shanxi, China, 710061
Contact: huaiyu Wang    0086-18991232410    whymed@126.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
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Study Chair: huaiyu Wang, doctor First Affiliated Hospital Xi'an Jiaotong University
More Information
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Publications of Results:

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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT04687657    
Other Study ID Numbers: XJTU1AF-CRF-2020-016
First Posted: December 29, 2020    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No sharing plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
Leukemia, Myelomonocytic, Acute
Umbilical cord blood transfusion
treatment effect
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myelomonocytic, Acute
 Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid