Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 3325 for:    China Medicine University Hospital

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02580071
Recruitment Status : Completed
First Posted : October 20, 2015
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Hung-Rong Yen, China Medical University Hospital

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.


Condition or disease Intervention/treatment Phase
Acute Leukemia Dietary Supplement: Sheng-Yu-Tang Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : October 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
Experimental: 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.

Dietary Supplement: 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 Names:
  • 聖愈湯
  • "Sagacious Cure Decoction"

No Intervention: Control
Control group will receive standard of care



Primary Outcome Measures :
  1. Peripheral blood Immune reconstitution [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Minimal residual disease (MRD) [ Time Frame: 1 year ]
  2. Bone marrow Immune reconstitution [ Time Frame: 1 year ]
  3. complete blood count [ Time Frame: 1 year ]
    WBC count WBC differential RBC count Hematocrit Hemoglobin Platelet Mean platelet volume ALT/AST gamma gt

  4. opportunistic infection [ Time Frame: 1 year ]
    Aspergillus Candida Herpes simplex virus (HSV) Cytomegalovirus (CMV) Varicella-zoster virus (VZV) Human herpes virus 6 (HHV6) Epstein-Barr virus

  5. GvHD [ Time Frame: 1 year ]
  6. frequency of hospitalizations [ Time Frame: 1 year ]
  7. Quality of Life [ Time Frame: 1 year ]
    QLQ-C30 Chinese Mandarin


Other Outcome Measures:
  1. Wang Q. constitution in Chinese medicine questionnaire [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580071


Locations
Layout table for location information
Taiwan
China Medical University Hospital
Taichung, Taiwan, 404
Sponsors and Collaborators
China Medical University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Hung-Rong Yen, M.D., Ph.D. China Medical University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hung-Rong Yen, Dr. Hung-Rong Yen, MD, PhD, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT02580071     History of Changes
Other Study ID Numbers: CMUH104-REC3-066
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by Hung-Rong Yen, China Medical University Hospital:
Hematopoietic Stem Cell Transplant
Chinese Herbal Medicine
immune reconstitution
clinical trial
ALL
AML

Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes