Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With AML

Sponsor
Anhui Provincial Hospital
Study ID
NCT06105658
Phase
PHASE2
Status
Unknown

Conditions

  • Acute Myelocytic Leukemia

Eligibility Criteria

Sex
ALL
Age
14 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Unrelated umbilical cord blood — BIOLOGICAL
    The requirements of unrelated umbilical cord blood: recipient-donor HLA match is 0-3/10, same blood type.
  • Venetoclax — DRUG
    Patients will be treated with Venetoclax (100 mg on day 1, 200 mg on day 2 and 400 mg on days 3 to 21)
  • Decetabine — DRUG
    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)
  • Azacitidine — DRUG
    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)

Study Details

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.

Key Dates

Start date
Oct 31, 2023
Status verified
Oct 2023
Primary completion
Feb 1, 2024
Completion
Feb 1, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chemotherapy+unrelated umbilical cord blood microtransplantation
    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".

Primary Outcome Measure

Complete response (CR) rate [ Time Frame: 28±7days ]

Central Contacts