Chinese Herbal Medicine for Immune Reconstitution Following HSCT in Acute Leukemia Patients

We hope to enroll 50 high-risk acute leukemia patients after receiving HSCT at China Medical University Hospital. Thereupon, patients will be consecutively recruited to treatment group (25 patients) where they will be prescribed Sheng Yu Tang (聖愈湯, SYT) 2 months following HSCT, for a period of 6 months, in conjunction with the standard-care treatment. We predict that not all patients will be interested in taking SYT, patients which are not interested in entering treatment group will be offered to join a control group (25 patients) which will receive standard-care treatment.

Since HSCT patients go through routine blood examinations, this study will request to extract a further 20ml of peripheral blood once a month and an additional 20ml of bone marrow at beginning of HSCT and the following routine aspirations (est.:0, +3, +6, +9, +12 month). Both treatment and control group will be required to contribute peripheral blood and bone marrow sample.Blood samples will be collected until patients reach 1-year post-HSCT, and flow cytometry will be used to examine the difference in immune reconstitution rate between the two groups. As secondary outcome measurements, this study will make use of the minimal residual disease (MRD) measured, frequency of opportunistic infections, hospitalizations and results of other routine check-up which recorded in patient history.

Inclusion criteria

• Discharged from hospital.
• Diagnosed with ALL, AML or MDS-AML.
• Received allogeneic or haploidentical peripheral blood HSCT.
• Willing to supply blood samples for analysis.
• Willing to comply with all study interventions and follow-ups.

Exclusion criteria

• unable, due to known allergy or any other reason, to orally take Chinese Herbal Medicine.