NCT04687657

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2021

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

3.1 years

First QC Date

December 27, 2020

Last Update Submit

August 18, 2021

Conditions

Leukemia, Myelomonocytic, Acute

Keywords

Leukemia, Myelomonocytic, AcuteUmbilical cord blood transfusiontreatment effect

Outcome Measures

Primary Outcomes (1)

  • 2-year Overall survival

    the overall survival rate of enrolled patients at the end of 2 years

    2-years

Secondary Outcomes (1)

  • 2-year Disease-free survival

    2-years

Study Arms (1)

cord blood transfusion

EXPERIMENTAL

The arm that will receive the target treatment.

Drug: umbilical cord blood

Interventions

umbilical cord bloodDRUG

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.

Also known as: cord blood
cord blood transfusion

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The first affiliated hospital of Xi'an jiaotong university

Xi’an, Shanxi, 710061, China

RECRUITING

Xi'anJiaotong University

Xi’an, Shanxi, 710061, China

NOT YET RECRUITING

Related Publications (6)

  • 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.

    PMID: 26376137RESULT

  • 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.

    PMID: 31429724RESULT

  • 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.

    PMID: 28280089RESULT

  • 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.

    PMID: 23673863RESULT

  • 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.

    PMID: 24488563RESULT

  • 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.

    PMID: 26779484RESULT

MeSH Terms

Conditions

Leukemia, Myelomonocytic, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • huaiyu Wang, doctor

    First Affiliated Hospital Xi'an Jiaotong University

    STUDY CHAIR

Central Study Contacts

huaiyu Wang, doctor

CONTACT

0086-18991232410whymed@126.com

sha Gong, doctor

CONTACT

0086-18710720955314621649@qq.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2020

First Posted

December 29, 2020

Study Start

February 1, 2021

Primary Completion

February 28, 2024

Study Completion

June 1, 2024

Last Updated

August 24, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

No sharing plan

Locations

CN(2)