Safety and Feasibility of Sulforaphane to Promote Early Haematopoietic Recovery After Cord Blood Transplantation

Inclusion criteria：

1. Patients with high-risk haematological malignancies: including AML, ALL, high-risk MDS
2. Age: ≥18 years
3. Karnofsky score ≥70%, Eastern Cooperative Oncology Group (ECOG) physical status ≤2 points
4. Selection of non-haematopoietic cord blood: donor-recipient HLA high-resolution compatibility ≥4/6, 7/10 and CD34 cells ≥0.83×105/kg (recipient's body weight), meeting the above criteria, only cord blood with a freezing time of ≥10 years can be found in China's public umbilical cord blood stem cell banks.

Exclusion criteria：

1. Patients who test positive for the following pathogens: HIV (HIV-1/2), human cytomegalovirus (HCMV-DNA), EBV (EBV-DNA), Hepatitis B (positive for Hepatitis B Surface Antigen (HBsAg) or Hepatitis B DNA (HBV-DNA)), Hepatitis C Antibody (HCV-Ab), Treponema pallidum Antibody (TP-Ab).
2. Active bacterial, viral, fungal or parasitic infections of clinical significance as judged by the investigator at the time of screening
3. Willing donors with full HLA compatibility and eligible for allogeneic haematopoietic stem cell transplantation
4. Previous gene therapy or allogeneic haematopoietic stem cell transplant recipients
5. Immediate family members with known or suspected familial cancer syndromes (including but not limited to hereditary breast and ovarian cancer syndromes, hereditary non-polyposis colorectal cancer syndromes, familial adenomatous polyposis, etc.)
6. Confirmed diagnosis of a major mental illness or predisposition to mental illness that would seriously affect the ability to participate in clinical research
7. History of major organ injury, including: Liver lesions: liver function tests suggesting AST or ALT \> 3 × ULN; total serum bilirubin \> 2.5 × ULN; total bilirubin \> 3 × ULN and direct bilirubin \> 2.5 × ULN if consistent with Gilbert's syndrome; history of hepatic pontine fibrosis, cirrhosis, and the presence of active hepatitis; Cardiac lesions: left ventricular ejection fraction ("LVEF") \< 45%; New York Heart Association (NYHA) class III or IV congestive heart failure (see Appendix 1 for classifications of heart failure); severe heart failure requiring treatment. Cardiac pathology: left ventricular ejection fraction (LVEF) \<45%; New York Heart Association (NYHA) class III or IV congestive heart failure (see Appendix 1 for NYHA heart failure classification); severe arrhythmia requiring treatment; uncontrolled hypertension or unstable angina; myocardial infarction or bypass or stent surgery within 12 months prior to enrolment; clinically significant valvular disease; calculated eGFR \<60mL/min/1.73m2 and direct bilirubin \>1.73m2; history of hepatic bridging fibrosis and cirrhosis; and presence of active hepatitis. Lung function: FEV1/FVC \<60% and/or diffusion function \<60% of predicted value; clinically significant evidence of pulmonary hypertension requiring medical intervention.
8. Uncorrectable coagulation disorders or history of severe bleeding disorders
9. Any other condition that, in the opinion of the doctor, makes the subject unsuitable for haematopoietic stem cell transplantation
10. Known allergy to the test drug or ingredients
11. Have participated or are participating in other interventional clinical studies within 3 months prior to screening
12. Live vaccination within 6 weeks prior to screening
13. Pregnant or breastfeeding women
14. Subjects did not follow the study protocol well
15. Any other condition deemed by the investigator to be unsuitable for participation in this clinical trial