NCT02580071

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

1.8 years

First QC Date

October 16, 2015

Last Update Submit

October 26, 2017

Conditions

Acute Leukemia

Keywords

Hematopoietic Stem Cell TransplantChinese Herbal Medicineimmune reconstitutionclinical trialALLAML

Outcome Measures

Primary Outcomes (1)

  • Peripheral blood Immune reconstitution

    1 year

Secondary Outcomes (7)

  • Minimal residual disease (MRD)

    1 year

  • Bone marrow Immune reconstitution

    1 year

  • complete blood count

    1 year

  • opportunistic infection

    1 year

  • GvHD

    1 year

  • +2 more secondary outcomes

Other Outcomes (1)

  • Wang Q. constitution in Chinese medicine questionnaire

    1 year

Study Arms (2)

Sheng-Yu-Tang

EXPERIMENTAL

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

Control

NO INTERVENTION

Control group will receive standard of care

Interventions

Sheng-Yu-TangDIETARY_SUPPLEMENT

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)

Also known as: 聖愈湯, "Sagacious Cure Decoction"
Sheng-Yu-Tang

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • unable, due to known allergy or any other reason, to orally take Chinese Herbal Medicine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 29431027DERIVED

Study Officials

  • Hung-Rong Yen, M.D., Ph.D.

    China Medical University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Hung-Rong Yen, MD, PhD

Study Record Dates

First Submitted

October 16, 2015

First Posted

October 20, 2015

Study Start

October 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

October 27, 2017

Record last verified: 2017-10

Locations

TW(1)