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

Acute Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580071
• Other study ID #: CMUH104-REC3-066
• Status: Completed
• Phase: N/A
• First received: October 16, 2015
• Last updated: October 26, 2017
• Start date: October 2015
• Est. completion date: August 2017

Study information

• Verified date: October 2017
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia
• Leukemia

Intervention

Dietary Supplement:
• Sheng-Yu-Tang
Granulated formula will be prescribed by KO DA Pharmaceutical co., LTD (??) 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)

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Wang Q. constitution in Chinese medicine questionnaire		1 year
Primary	Peripheral blood Immune reconstitution		1 year
Secondary	Minimal residual disease (MRD)		1 year
Secondary	Bone marrow Immune reconstitution		1 year
Secondary	complete blood count	WBC count WBC differential RBC count Hematocrit Hemoglobin Platelet Mean platelet volume ALT/AST gamma gt	1 year
Secondary	opportunistic infection	Aspergillus Candida Herpes simplex virus (HSV) Cytomegalovirus (CMV) Varicella-zoster virus (VZV) Human herpes virus 6 (HHV6) Epstein-Barr virus	1 year
Secondary	GvHD		1 year
Secondary	frequency of hospitalizations		1 year
Secondary	Quality of Life	QLQ-C30 Chinese Mandarin	1 year