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NCT06458257Recruiting

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

Source: ClinicalTrials.gov · Last updated 29 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
50 (estimated)
First submitted
9 Jan 2024
Start date
19 Oct 2024
Primary completion date
31 Dec 2026
Lead sponsor
Ruijin Hospital
NCT number
NCT06458257

What you commit to

  • Study type: Observational
  • Planned participants: 50
  • From 19 Oct 2024 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concomitant other hematologic diseases (including coagulation abnormalities unrelated to leukemia);

Other illness

  • Allergies or contraindications to any of the drugs involved in the protocol;
  • Lung diseases: pulmonary edema, pleural effusion (CTCAE score \>2);
  • Suffering from malignant tumors of other organs at the same time;
  • Active patients with HAV, HBV, HCV and tuberculosis, HIV-positive patients;
  • Those who participate in other clinical studies at the same time; Presence of any other condition that would preclude the conduct of the study

Lab values

  • Cardiac disease: including echocardiogram EF \<50%, cardiac insufficiency (New York cardiac function classification NYHA: III/IV), pericardial effusion (CTCAE score \>2) within six months after acute myocardial infarction, ECG QTc \>470ms;

Other

  • MDS-converted AML, treatment-related AML; mixed cell leukemia; AML patients with central nervous system infiltrates and extramedullary lesions at the time of onset;
  • Relapse patients;
  • Liver and kidney function are obviously abnormal, exceeding the enrollment criteria;
  • Inability to understand or follow the study protocol;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.