The Efficacy of Allogeneic Hematopoietic Stem Cell Transplantation in Newly Diagnosed High-relapse-risk CEBPA Mutant Acute Myeloid Leukemia

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Observational
SUMMARY

For newly diagnosed high-relapse-risk CEBPA mutant acute myeloid leukemia patients, we aim to perform allogeneic hematopoietic stem cell transplantation after patients finished one cycle of induction and two cycles of consolidation. To access whether the therapeutic regimen is effective for high-relapse-risk CEBPA mutant acute myeloid leukemia, the disease-free-survival (DFS), overall survival (OS), non-relapse-mortality of patients is evaluated.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
View:

• Patients with confirmed CEBPA mutant AML. Diagnostic criteria include the presence of CEBPA mutant gene detected at the molecular level;

• Patients with high-risk molecular markers or gene mutations, or complex karyotypes for disease recurrence, or flow cytometry/gene MRD positivity after two chemotherapy treatments; high-risk molecular markers or gene mutations include: CD7 positive, WT1 mutation, non-bzip-inframe CEBPA mutation; The positive threshold for flow cytometry MRD was 0.0001%; The MRD threshold of molecular biology is the lowest value of the detection protocol of the center.

• Medical history and diagnosis of MICM, exclusion of MDS, transformation and treatment-related AML;

• Age 18-65 years old (18 years old ≤Age\< 65 years old);

• Liver and kidney function: blood bilirubin ≤ 35 μmol/L, AST/ALT below 2 times the upper limit of normal, serum creatinine ≤ 150 μmol/L;

• Normal cardiac function (EF≥50%, New York Cardiac Function Classification NYHA I/II);

• Physical condition score 0-2 (ECOG score);

• For patients with peripheral blood leukocytes \< 50\*109/L at the initial onset, no chemotherapy has been given except for hydroxyurea before the start of induction therapy;

• For patients with peripheral blood leukocytes ≥ 50\*109/L at the initial onset, cytarabine and hydroxyurea are allowed to be treated before the start of induction therapy;

⁃ Non-pregnant and lactating women;

⁃ For all women of childbearing age, a pregnancy test must be performed to measure hCG to rule out pregnancy;

⁃ Obtain informed consent signed by the patient or family member.

Locations
Other Locations
China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School Of Medicine
RECRUITING
Shanghai
Time Frame
Start Date: 2024-10-19
Estimated Completion Date: 2028-12
Participants
Target number of participants: 50
Treatments
HSCT-group
patients received allogeneic hematopoietic stem cell transplantation after consolidation treatment
Chemo-group
patients received chemotherapy after consolidation treatment
Sponsors
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov

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