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

Study Overview
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Brief Summary
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The treatment options for high-risk acute leukemia patients are limited and these patients are often opt for hematopoietic stem cell transplant (HSCT). However studies show that prognosis following this last-resort therapy is bleak. At times, less than 70% of post-HSCT relapsed AML and ALL patients even achieve complete remission; median overall survival of these cohorts might not reach one year; and 3-year post-HSCT survival rates might be less than 20%. The investigators plan to recruit acute leukemia patients from CMUH which are planned to receive HSCT, and follow the rate and quality of their immune reconstitution. As intervention, part of the patients will receive a Chinese medicine herbal formula, which they will take for 6 months.Differences between the 1-year post-HSCT condition of patients will be examined.

Detailed Description
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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.

Official Title
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An Open Label, Non-randomized, Clinical Study of Chinese Medicine, Sheng-Yu-Tang, for Immune Reconstitution Following Peripheral Blood Stem Cell Transplantation in >CR1 (Complete Remission) and Refractory Acute Leukemia Patients

Conditions
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Acute Leukemia

Intervention / Treatment
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* Dietary Supplement: Sheng-Yu-Tang


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sheng-Yu-Tang<br>Treatment group will receive standard of care, as well as: 2-3 months post-HSCT, patients will be administered the herbal formula Sheng-Yu-Tang (聖愈湯), which they will receive for 6 months. The herbal formula will be provided from a GMP herbal company and will be given in granulated form. | Dietary Supplement: Sheng-Yu-Tang<br>* Granulated formula will be prescribed by KO DA Pharmaceutical co., LTD (科達) composition of formula is as follows: Radix Rehmanniae Praeparata 4g Radix Paeoniae Alba 4g Radix Astragali 4g Radix Ginseng 4g Radix Angelice Sinensis 2g Rhizoma Chuanxiong 2g (for preperation method and concentration ratio's please refer to manufacturers information) patients will be required to take 4.2gr, t.i.d (total of 12.6gr per day)<br>* Other names: Sagacious Cure Decoction;|
| No Intervention: Control<br>Control group will receive standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral blood Immune reconstitution |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal residual disease (MRD) |  | 1 year | 
| Bone marrow Immune reconstitution |  | 1 year | 
| complete blood count | WBC count WBC differential RBC count Hematocrit Hemoglobin Platelet Mean platelet volume ALT/AST gamma gt | 1 year | 
| opportunistic infection | Aspergillus Candida Herpes simplex virus (HSV) Cytomegalovirus (CMV) Varicella-zoster virus (VZV) Human herpes virus 6 (HHV6) Epstein-Barr virus | 1 year | 
| GvHD |  | 1 year | 
| frequency of hospitalizations |  | 1 year | 
| Quality of Life | QLQ-C30 Chinese Mandarin | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematopoietic Stem Cell Transplant, Chinese Herbal Medicine, immune reconstitution, clinical trial, ALL, AML