Myelodysplastic Syndrome (MDS)Phase 1/2NCT01224496
Traditional Chinese Medicine in the Supportive Management of Anaemic and Cytopenic (Leukopenia, Thrombocytopenia) Haematological Disorders
A Phase 1/2 study testing Chinese herbal concoction twice a day for 6 months in people with Myelodysplastic Syndrome (MDS) and Aplastic Anaemia (AA), run by Singapore General Hospital at 1 site in Singapore.
Trial summary
The purpose of this study is to study the efficacy of Traditional Chinese Medicine (TCM) on anaemic and cytopenic haematological disorders including myelodysplastic syndrome (MDS), aplastic anaemia (AA), myelofibrosis (MF) and thalassemia intermedia who do not have or did not respond to available treatment options. Read more about this study
- Who is it for?
- Ages 13 to 85 years
- Conditions the study is for
- Myelodysplastic Syndrome (MDS), Aplastic Anaemia (AA), Myelofibrosis (MF)
- What is being tested?
- Chinese herbal concoction twice a day for 6 months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2009to Aug 2011
- Phase
- Phase 1/2
- 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 13 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A diagnosis of MDS, AA, MF or thal based on currently recognized diagnostic criteria.
- Explored or undergone established therapies eg haemopoietic stem cell transplant, immunosuppressive therapy, chemotherapy, growth factors, thalidomide, hypomethylating agent or androgens, and (a) are deemed not suitable, or (b) refuse or (c) have failed therapy
- A preceding follow up period (without or with treatment) of 2-4 months as baseline (depending on the severity of cytopenia) before being enrolled into this study
- Understand the trial nature of this treatment, agree to be compliant to medication, do not self medicate and have signed informed consent
- Agreeable to regular blood tests and follow up marrow study as listed in schedule
Who cannot join
- Life expectancy of shorter than one year
- Significant organ failure including the following
- Renal impairment with Cr above 200umol/L
- Liver impairment with serum bilirubin > 2x upper limits or transaminase >3x upper limits
- Escalation of treatment of introduction of new agents including growth factors, thalidomide, hypomethylating agents, immunosuppressive therapy or androgens once started on treatment with TCM is not allowed. Continuation of current therapy at same or lower doses is allowed
- Women during pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to study the efficacy of Traditional Chinese Medicine (TCM) on anaemic and cytopenic haematological disorders including myelodysplastic syndrome (MDS), aplastic anaemia (AA), myelofibrosis (MF) and thalassemia intermedia who do not have or did not respond to available treatment options.
- Conditions
- Myelodysplastic Syndrome (MDS), Aplastic Anaemia (AA), Myelofibrosis (MF), Thalassemia Intermedia
- Being tested
- Chinese herbal concoction twice a day for 6 months
- Keywords
- Chronic cytopenic haematological diseases, Chinese herbal concoction, Supportive management
- Medical subject headings
- Myelodysplastic Syndromes, Anemia, Aplastic, Primary Myelofibrosis, beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herbal concoction twice a day for 6 monthsDrug
Definition of each TCM syndrome is based on TCM theory. Formulation composition is based on each defined TCM syndrome with addition or removal of herbs as indicated by the patient's manifestation
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Chinese herbal concoction | Experimental | Patients must have a marrow study to confirm diagnosis of MDS, AA or MF. MDS is classified according to the WHO criteria and scored according to IPSS. The AA group is further classified into AA, SAA or VSAA . MF is defined by the Italian criteria and risk stratified by the Lilles Scoring system. Diagnosis of thal intermedia and major is based on previously done Hb electrophoresis and severity of disease is assessed by degree of anaemia.and frequency of blood transfusions
TCM diagnosis: Syndrome differentiation according to TCM theory will be assessed as a baseline by experienced TCM collaborators and classified into one of the few defined syndromes as follows
1. Yin deficiency of spleen and kidney
2. Yang deficiency of spleen and kidney
3. Deficiency of both Yin and Yang
4. Stagnation of dampness and poison in the blood
5. Excessive heat and poison Receives: Drug: Chinese herbal concoction twice a day for 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
The following parameters will be monitored serially
- symptoms : ie reflection of any subjective symptoms that may be due to the treatment
- Serial biochemistry ( urea, electrolyte, creatinine, liver function test ) will be done at baseline, one week into the study and then every 7-8 weekly till end of the 6 months. This will monitor for any organ toxicity
Measured: 6 months
Secondary outcomes (2)
Quality of life
Quality of life (QOL) will be measured based on the EORTC QLQ C30. THis will be taken at enrolment and at 2 monthly intervals
Measured: 6 months
Haematological improvement
The haematological response crietria is based on those published as follows
For MDS : Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood 2000 Dec 1;96(12):3671-4.
For MF : Response criteria for myelofibrosis with myeloid metaplasia: results of an initiative of the European Myelofibrosis Network (EUMNET). Blood 2005 Oct 15;106(8):2849-53.
For AA : Aplastic Anemia, Pathophysiology and Treatment. Cambridge: Cambridge University Press; 2000.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startJul 2009
- Primary completionAug 2011
- Study completionAug 2011
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 Myelodysplastic Syndrome (MDS)Studies of the same condition, open and under way.
- More trials run by Singapore General 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Yueyang Integrated Medicine Hospital, Singapore Bao Zhong Tang TCM Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224496
- Sponsor's protocol ID
- SHF/TCM002/2008
- Status last verified
- Feb 2017
- First submitted
- 3 Oct 2010
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Linn YC, Lu J, Lim LC, Sun H, Sun J, Zhou Y. Traditional Chinese herbal medicine in the supportive management of patients with chronic cytopaenic marrow diseases -- a phase I/II clinical study. Complement Ther Clin Pract. 2011 Aug;17(3):152-6. doi: 10.1016/j.ctcp.2011.01.004. Epub 2011 Feb 17.
PubMed 21742281
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Chinese Medicine in the Supportive Management of Anaemic and Cytopenic (Leukopenia, Thrombocytopenia) Haematological Disorders
- ClinicalTrials.gov ID
- NCT01224496
- Acronym / sponsor ID
- SHF/TCM002/2008
- Conditions
- Myelodysplastic Syndrome (MDS), Aplastic Anaemia (AA), Myelofibrosis (MF), Thalassemia Intermedia
- Keywords
- Chronic cytopenic haematological diseases, Chinese herbal concoction, Supportive management
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Shanghai Yueyang Integrated Medicine Hospital, Singapore Bao Zhong Tang TCM Center
- Study start
- Jul 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 20 Oct 2010 (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 purpose of this study is to study the efficacy of Traditional Chinese Medicine (TCM) on anaemic and cytopenic haematological disorders including myelodysplastic syndrome (MDS), aplastic anaemia (AA), myelofibrosis (MF) and thalassemia intermedia who do not have or did not respond to available treatment options.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Chinese herbal concoction | Experimental | Drug: Chinese herbal concoction twice a day for 6 monthsPatients must have a marrow study to confirm diagnosis of MDS, AA or MF. MDS is classified according to the WHO criteria and scored according to IPSS. The AA group is further classified into AA, SAA or VSAA . MF is defined by the Italian criteria and risk stratified by the Lilles Scoring system. Diagnosis of thal intermedia and major is based on previously done Hb electrophoresis and severity of disease is assessed by degree of anaemia.and frequency of blood transfusions TCM diagnosis: Syndrome differentiation according to TCM theory will be assessed as a baseline by experienced TCM collaborators and classified into one of the few defined syndromes as follows 1. Yin deficiency of spleen and kidney 2. Yang deficiency of spleen and kidney 3. Deficiency of both Yin and Yang 4. Stagnation of dampness and poison in the blood 5. Excessive heat and poison |
Who may qualify
- Ages
- 13 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- A diagnosis of MDS, AA, MF or thal based on currently recognized diagnostic criteria.
- Explored or undergone established therapies eg haemopoietic stem cell transplant, immunosuppressive therapy, chemotherapy, growth factors, thalidomide, hypomethylating agent or androgens, and (a) are deemed not suitable, or (b) refuse or (c) have failed therapy
- A preceding follow up period (without or with treatment) of 2-4 months as baseline (depending on the severity of cytopenia) before being enrolled into this study
- Understand the trial nature of this treatment, agree to be compliant to medication, do not self medicate and have signed informed consent
- Agreeable to regular blood tests and follow up marrow study as listed in schedule
Key exclusion criteria (6 listed)
- Life expectancy of shorter than one year
- Significant organ failure including the following
- Renal impairment with Cr above 200umol/L
- Liver impairment with serum bilirubin > 2x upper limits or transaminase >3x upper limits
- Escalation of treatment of introduction of new agents including growth factors, thalidomide, hypomethylating agents, immunosuppressive therapy or androgens once started on treatment with TCM is not allowed. Continuation of current therapy at same or lower doses is allowed
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 |
|---|---|---|
| Chinese herbal concoction twice a day for 6 monthsDefinition of each TCM syndrome is based on TCM theory. Formulation composition is based on each defined TCM syndrome with addition or removal of herbs as indicated by the patient's manifestation | Drug | Treatment with Chinese herbal concoction |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 6 months
The following parameters will be monitored serially 1. symptoms : ie reflection of any subjective symptoms that may be due to the treatment 2. Serial biochemistry ( urea, electrolyte, creatinine, liver function test ) will be done at baseline, one week into the study and then every 7-8 weekly till end of the 6 months. This will monitor for any organ toxicity
2 secondary outcomes
Quality of life
Time frame: 6 months
Haematological improvement
Time frame: 6 months
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 10 Feb 2017.
- Derived from this study: PubMed 21742281Linn YC, Lu J, Lim LC, Sun H, Sun J, Zhou Y. Traditional Chinese herbal medicine in the supportive management of patients with chronic cytopaenic marrow diseases -- a phase I/II clinical study. Complement Ther Clin Pract. 2011 Aug;17(3):152-6. doi: 10.1016/j.ctcp.2011.01.004. Epub 2011 Feb 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Chinese herbal concoction twice a day for 6 months in people with Myelodysplastic Syndrome (MDS) and Aplastic Anaemia (AA), run by Singapore General Hospital at 1 site in Singapore.
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 6 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 10 Feb 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 Singapore. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 6 months). 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 NCT01224496, 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 10 Feb 2017.