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

Primary Purpose

Leukemia, Myelomonocytic, Acute

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
umbilical cord blood
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myelomonocytic, Acute focused on measuring Leukemia, Myelomonocytic, Acute, Umbilical cord blood transfusion, treatment effect

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The first affiliated hospital of Xi'an jiaotong universityRecruiting
  • Xi'anJiaotong University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cord blood transfusion

Arm Description

The arm that will receive the target treatment.

Outcomes

Primary Outcome Measures

2-year Overall survival
the overall survival rate of enrolled patients at the end of 2 years

Secondary Outcome Measures

2-year Disease-free survival
DFS is measured from the date when CR is achieved. And the end includes death or relapse.

Full Information

First Posted
December 27, 2020
Last Updated
August 18, 2021
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT04687657
Brief Title
Umbilical Cord Blood Transfusion in Consolidation Therapy of Elderly Patients With Acute Myeloid Leukemia
Official Title
Application of Umbilical Cord Blood Transfusion in Consolidation Therapy of Elderly Patients With Acute Myeloid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelomonocytic, Acute
Keywords
Leukemia, Myelomonocytic, Acute, Umbilical cord blood transfusion, treatment effect

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 transfusion
Arm Type
Experimental
Arm Description
The arm that will receive the target treatment.
Intervention Type
Drug
Intervention Name(s)
umbilical cord blood
Other Intervention Name(s)
cord blood
Intervention Description
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.
Primary Outcome Measure Information:
Title
2-year Overall survival
Description
the overall survival rate of enrolled patients at the end of 2 years
Time Frame
2-years
Secondary Outcome Measure Information:
Title
2-year Disease-free survival
Description
DFS is measured from the date when CR is achieved. And the end includes death or relapse.
Time Frame
2-years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
huaiyu Wang, doctor
Phone
0086-18991232410
Email
whymed@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
sha Gong, doctor
Phone
0086-18710720955
Email
314621649@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
huaiyu Wang, doctor
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Study Chair
Facility Information:
Facility Name
The first affiliated hospital of Xi'an jiaotong university
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
huaiyu Wang
Phone
085-18991232410
Facility Name
Xi'anJiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
huaiyu Wang
Phone
0086-18991232410
Email
whymed@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No sharing plan
Citations:
PubMed Identifier
26376137
Citation
Dohner H, Weisdorf DJ, Bloomfield CD. Acute Myeloid Leukemia. N Engl J Med. 2015 Sep 17;373(12):1136-52. doi: 10.1056/NEJMra1406184. No abstract available.
Results Reference
result
PubMed Identifier
31429724
Citation
Li X, Dong Y, Li Y, Ren R, Wu W, Zhu H, Zhang Y, Hu J, Li J. Low-dose decitabine priming with intermediate-dose cytarabine followed by umbilical cord blood infusion as consolidation therapy for elderly patients with acute myeloid leukemia: a phase II single-arm study. BMC Cancer. 2019 Aug 20;19(1):819. doi: 10.1186/s12885-019-5975-8.
Results Reference
result
PubMed Identifier
28280089
Citation
Dolstra H, Roeven MWH, Spanholtz J, Hangalapura BN, Tordoir M, Maas F, Leenders M, Bohme F, Kok N, Trilsbeek C, Paardekooper J, van der Waart AB, Westerweel PE, Snijders TJF, Cornelissen J, Bos G, Pruijt HFM, de Graaf AO, van der Reijden BA, Jansen JH, van der Meer A, Huls G, Cany J, Preijers F, Blijlevens NMA, Schaap NM. Successful Transfer of Umbilical Cord Blood CD34+ Hematopoietic Stem and Progenitor-derived NK Cells in Older Acute Myeloid Leukemia Patients. Clin Cancer Res. 2017 Aug 1;23(15):4107-4118. doi: 10.1158/1078-0432.CCR-16-2981. Epub 2017 Mar 9.
Results Reference
result
PubMed Identifier
23673863
Citation
Ballen KK, Gluckman E, Broxmeyer HE. Umbilical cord blood transplantation: the first 25 years and beyond. Blood. 2013 Jul 25;122(4):491-8. doi: 10.1182/blood-2013-02-453175. Epub 2013 May 14.
Results Reference
result
PubMed Identifier
24488563
Citation
Stringaris K, Sekine T, Khoder A, Alsuliman A, Razzaghi B, Sargeant R, Pavlu J, Brisley G, de Lavallade H, Sarvaria A, Marin D, Mielke S, Apperley JF, Shpall EJ, Barrett AJ, Rezvani K. Leukemia-induced phenotypic and functional defects in natural killer cells predict failure to achieve remission in acute myeloid leukemia. Haematologica. 2014 May;99(5):836-47. doi: 10.3324/haematol.2013.087536. Epub 2014 Jan 31.
Results Reference
result
PubMed Identifier
26779484
Citation
Mehta RS, Shpall EJ, Rezvani K. Cord Blood as a Source of Natural Killer Cells. Front Med (Lausanne). 2016 Jan 5;2:93. doi: 10.3389/fmed.2015.00093. eCollection 2015.
Results Reference
result

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

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