Clinical trial NCT02580071: Chinese Herbal Medicine for Immune Reconstitution Following HSCT in Acute Leukemia Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Leukemia
Keywords: Hematopoietic Stem Cell Transplant
Chinese Herbal Medicine
immune reconstitution
clinical trial
ALL
AML
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Peripheral blood Immune reconstitution
timeFrame: 1 year
Secondary outcomes:
measure: Minimal residual disease (MRD)
timeFrame: 1 year
measure: Bone marrow Immune reconstitution
timeFrame: 1 year
measure: complete blood count
timeFrame: 1 year
measure: opportunistic infection
timeFrame: 1 year
measure: GvHD
timeFrame: 1 year
measure: frequency of hospitalizations
timeFrame: 1 year
measure: Quality of Life
timeFrame: 1 year
Other outcomes:
measure: Wang Q. constitution in Chinese medicine questionnaire
timeFrame: 1 year
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Hung-Rong Yen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.