NCT06105658

Brief Summary

This study aimed to evaluate the safety and efficacy of unrelated umbilical cord blood microtransplantation in the treatment of AML patients by observing the factors related to the efficacy and adverse reactions.

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 below P25 for phase_2

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 2023

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

October 19, 2023

Last Update Submit

October 27, 2023

Conditions

Acute Myelocytic Leukemia

Outcome Measures

Primary Outcomes (2)

  • Complete response (CR) rate

    CR rate is defined as the percentage of patients who met the following conditions: Myelogram: naïve cells less than 5% (at least 200 nucleated cells); Hemogram: absolute neutrophil count \> 1.0×10\^9/L, platelet count \> 100×10\^9/L; Clinical diagnosis: no symptoms and signs caused by leukemia infiltration, and patients do not rely on blood transfusion.

    28±7days

  • Hematopoietic recovery time

    The time of absolute neutrophil count\>0.5×10\^9/L and platelet count \>30×10\^9/L for 3 consecutive days.

    28±7days

Secondary Outcomes (4)

  • Time to Progression（TTP）

    1 year

  • Disease Free Survival（DFS）

    1 year

  • Overall Survival（OS）

    1 year

  • Early mortality rate

    3 months

Other Outcomes (2)

  • Changes in lymphocyte subsets (NK cells, T cells) before and after treatment

    At the time of enrollment and at 1 month

  • Correlation between human leukocyte antigen (HLA) matching and the concentration of lymphocyte subsets

    HLA typing and matching will be assessed at the time of enrollment, and the concentration of lymphocyte subsets in peripheral blood will be detected at the time of enrollment and at 1 month

Study Arms (1)

Chemotherapy+unrelated umbilical cord blood microtransplantation

EXPERIMENTAL

Intermittent infusion of HLA mismatched or incompletely matched granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood stem cells (G-PBSC) during routine chemotherapy without the use of immunosuppressants, abbreviated as "microtransplantation".

Biological: Unrelated umbilical cord bloodDrug: VenetoclaxDrug: DecetabineDrug: Azacitidine

Interventions

Unrelated umbilical cord bloodBIOLOGICAL

The requirements of unrelated umbilical cord blood: recipient-donor HLA match is 0-3/10, same blood type.

Chemotherapy+unrelated umbilical cord blood microtransplantation
VenetoclaxDRUG

Patients will be treated with Venetoclax (100 mg on day 1, 200 mg on day 2 and 400 mg on days 3 to 21)

Chemotherapy+unrelated umbilical cord blood microtransplantation
DecetabineDRUG

Patients will be treated with Decetabine (20mg/m\^2/d on days 1 to 5) or Azacitidine (75mg/m\^2/d on days 1 to 7)

Chemotherapy+unrelated umbilical cord blood microtransplantation
AzacitidineDRUG

Patients will be treated with Decetabine (20mg/m\^2/d on days 1 to 5) or Azacitidine (75mg/m\^2/d on days 1 to 7)

Chemotherapy+unrelated umbilical cord blood microtransplantation

Eligibility Criteria

Age14 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with AML through bone marrow morphology, histochemistry, immunophenotyping, pathological testing, etc. Besides, patients should meet the following conditions:
  • Patients aged 60-80 who newly diagnosed AML with WHO criteria and have not received prior treatment for acute leukemia (hydroxyurea or pre-chemotherapy is allowed for patients with high leukocyte).
  • Patients aged 14-60 who do not meet the indications for hematopoietic stem cell transplantation;
  • Gender and race are not limited;
  • Karnofsky score ≥ 60%, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
  • Expected survival time ≥ 3 months;
  • The examination results meet the following requirements:
  • ALT and AST ≤ 3 × Upper limit of normal value (ULN); Total bilirubin ≤ 3 × ULN; Creatinine ≤ 2 × ULN or creatinine clearance rate ≥ 40mL/min; The left ventricular ejection fraction (LVEF) measured by echocardiography or multigated acquisition (MUGA) scanning is within the normal range (\>50%);
  • The recipient and selected donor should be 0-3/10 HLA-matched with same blood type;
  • Patients who voluntarily participate in this clinical study and have signed an informed consent.

You may not qualify if:

  • Patients who have suffered from malignant tumors;
  • Patients have suffered from hematopoietic failure after chemotherapy, and have undergone ineffective blood transfusion with unknown cause;
  • Patients who have undergone Class II or above surgery within 4 weeks prior to enrollment;
  • Suffering from life-threatening diseases other than AML;
  • Allergic to the drugs in the research;
  • Patient with severe cardiac insufficiency, including uncontrolled or symptomatic arrhythmia, congestive heart failure, myocardial infarction within 6 months, or any grade 3 (moderate) or grade 4 (severe) heart disease;
  • Patients with test positive for HIV, HCV or HBV;
  • Stroke or intracranial hemorrhage occurred within 6 months prior to enrollment;
  • Warfarin or vitamin K antagonists (such as phenprocoumarin) is necessary for anticoagulation;
  • Patients with mental illnesses or cognitive impairments;
  • Patients have participated within the month prior to enrollment or patients are currently participating in other clinical trials;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, 230001, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclaxAzacitidine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Xiaoyu Zhu, MD

    The First Affiliated Hospital of University of Science and Technology of China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyu Zhu, MD

CONTACT

15255456091xiaoyuz@ustc.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 19, 2023

First Posted

October 27, 2023

Study Start

October 1, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2026

Last Updated

October 30, 2023

Record last verified: 2023-10

Locations

CN(1)