Acute LeukemiaNCT02580071
Chinese Herbal Medicine for Immune Reconstitution Following HSCT in Acute Leukemia Patients
A study testing Sheng-Yu-Tang in people with Acute Leukemia, run by China Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- Sheng-Yu-Tang
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2015to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- unable, due to known allergy or any other reason, to orally take Chinese Herbal Medicine.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Acute Leukemia
- Being tested
- Sheng-Yu-Tang
- Keywords
- Hematopoietic Stem Cell Transplant, Chinese Herbal Medicine, immune reconstitution, clinical trial, ALL, AML
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sheng-Yu-TangDietary supplement
Also called 聖愈湯, "Sagacious Cure Decoction"
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Sheng-Yu-Tang |
| Control | No intervention | Control group will receive standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral blood Immune reconstitution
Measured: 1 year
Secondary outcomes (7)
Minimal residual disease (MRD)
Measured: 1 year
Bone marrow Immune reconstitution
Measured: 1 year
complete blood count
WBC count WBC differential RBC count Hematocrit Hemoglobin Platelet Mean platelet volume ALT/AST gamma gt
Measured: 1 year
opportunistic infection
Aspergillus Candida Herpes simplex virus (HSV) Cytomegalovirus (CMV) Varicella-zoster virus (VZV) Human herpes virus 6 (HHV6) Epstein-Barr virus
Measured: 1 year
GvHD
Measured: 1 year
frequency of hospitalizations
Measured: 1 year
Quality of Life
QLQ-C30 Chinese Mandarin
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hung-Rong Yen, China Medical University Hospital
- Investigators
- Hung-Rong Yen, M.D., Ph.D., Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580071
- Sponsor's protocol ID
- CMUH104-REC3-066
- Status last verified
- Oct 2017
- First submitted
- 16 Oct 2015
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29431027
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02580071
- Acronym / sponsor ID
- CMUH104-REC3-066
- Conditions
- Acute Leukemia
- Keywords
- Hematopoietic Stem Cell Transplant, Chinese Herbal Medicine, immune reconstitution, clinical trial, ALL, AML
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sheng-Yu-Tang | Experimental | Dietary Supplement: Sheng-Yu-TangTreatment 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. |
| Control | No intervention | –Control group will receive standard of care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- unable, due to known allergy or any other reason, to orally take Chinese Herbal Medicine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sheng-Yu-TangAlso: 聖愈湯, "Sagacious Cure Decoction"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) | Dietary supplement | Sheng-Yu-Tang |
Primary outcome
Peripheral blood Immune reconstitution
Time frame: 1 year
7 secondary outcomes
Minimal residual disease (MRD)
Time frame: 1 year
Bone marrow Immune reconstitution
Time frame: 1 year
complete blood count
Time frame: 1 year
opportunistic infection
Time frame: 1 year
GvHD
Time frame: 1 year
frequency of hospitalizations
Time frame: 1 year
Quality of Life
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Derived from this study: PubMed 29431027Fleischer 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.
Related trials for Acute Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hung-Rong Yen, M.D., Ph.D. principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sheng-Yu-Tang in people with Acute Leukemia, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral blood Immune reconstitution (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02580071, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.