The Efficacy of Allogeneic Hematopoietic Stem Cell Transplantation in Newly Diagnosed High-relapse-risk Core-binding-factor Acute Myeloid Leukemia

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

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

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

• Participants with confirmed CBF-AML. Diagnostic criteria include the presence of t(8; 21)(q22; q22)/RUNX1-RUNX1T1 fusion gene detected at the molecular level; or chromosome presence of inv(16)(p13.1q22)/t(16; 16)(p13.1; q22) /Detection of CBFβ-MYH11 fusion gene at the molecular level;

• Participants with high-risk gene mutations or complex karyotypes for disease recurrence, or flow cytometry/gene MRD positivity after two chemotherapy treatments; High-risk gene mutations include: TP53, RTK/RAS signaling (FLT3, NRAS, KRAS, KIT, JAK2, CSF3R), chromatin modification (ASXL1, ASXL2, KMD6A, EZH2, SETD2) or mutations listed as intermediate-risk or high-risk in the 2022NCCN guidelines; 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 participants 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 participants 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
Contact Information
Primary
Yang Shen, MD, PhD
shen_yang@126.com
02164370045
Time Frame
Start Date: 2024-09-21
Estimated Completion Date: 2028-02
Participants
Target number of participants: 90
Treatments
HSCT-group
The participants receive HSCT after two-cycle of consolidation treatment.
Chemo-group
The participants receive chemotherapy after two-cycle of consolidation treatment.
Sponsors
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov