Clinical trial NCT04687657: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Leukemia, Myelomonocytic, Acute
Keywords: Leukemia, Myelomonocytic, Acute
Umbilical cord blood transfusion
treatment effect
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 2-year Overall survival
timeFrame: 2-years
Secondary outcomes:
measure: 2-year Disease-free survival
timeFrame: 2-years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The first affiliated hospital of Xi'an jiaotong university
state: Shanxi
city: Xi'an
country: China
facility: Xi'anJiaotong University
state: Shanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: huaiyu Wang, doctor
role: STUDY_CHAIR
References:
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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.
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