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

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Inclusion criteria

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• Patients with high-risk haematological malignancies: including AML, ALL, high-risk MDS
• Age: ≥18 years
• Karnofsky score ≥70%, Eastern Cooperative Oncology Group (ECOG) physical status ≤2 points
• 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

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• 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).
• Active bacterial, viral, fungal or parasitic infections of clinical significance as judged by the investigator at the time of screening
• Willing donors with full HLA compatibility and eligible for allogeneic haematopoietic stem cell transplantation
• Previous gene therapy or allogeneic haematopoietic stem cell transplant recipients
• 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.)
• Confirmed diagnosis of a major mental illness or predisposition to mental illness that would seriously affect the ability to participate in clinical research
• 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.
• Uncorrectable coagulation disorders or history of severe bleeding disorders
• Any other condition that, in the opinion of the doctor, makes the subject unsuitable for haematopoietic stem cell transplantation
• Known allergy to the test drug or ingredients
• Have participated or are participating in other interventional clinical studies within 3 months prior to screening
• Live vaccination within 6 weeks prior to screening
• Pregnant or breastfeeding women
• Subjects did not follow the study protocol well
• Any other condition deemed by the investigator to be unsuitable for participation in this clinical trial