Chinese Herbal Medicine for Immune Reconstitution Following HSCT in Acute Leukemia Patients
NCT ID: NCT02580071
Last Updated: 2017-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2015-10-31
2017-08-31
Brief Summary
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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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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Sheng-Yu-Tang
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.
Sheng-Yu-Tang
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)
Control
Control group will receive standard of care
No interventions assigned to this group
Interventions
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Sheng-Yu-Tang
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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China Medical University Hospital
OTHER
Responsible Party
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Hung-Rong Yen
Dr. Hung-Rong Yen, MD, PhD
Principal Investigators
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Hung-Rong Yen, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
China Medical University Hospital
Locations
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China Medical University Hospital
Taichung, , Taiwan
Countries
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References
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Fleischer T, Chang TT, Chiang JH, Yen HR. A Controlled Trial of Sheng-Yu-Tang for Post-Hematopoietic Stem Cell Transplantation Leukemia Patients: A Proposed Protocol and Insights From a Preliminary Pilot Study. Integr Cancer Ther. 2018 Sep;17(3):665-673. doi: 10.1177/1534735418756736. Epub 2018 Feb 11.
Other Identifiers
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CMUH104-REC3-066
Identifier Type: -
Identifier Source: org_study_id