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Traditional Chinese Medicine in the Supportive Management of Anaemic and Cytopenic (Leukopenia, Thrombocytopenia) Haematological Disorders


Phase 1/Phase 2
13 Years
85 Years
Not Enrolling
Both
Myelodysplastic Syndrome (MDS), Aplastic Anaemia (AA), Myelofibrosis (MF), Thalassemia Intermedia

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Trial Information

Traditional Chinese Medicine in the Supportive Management of Anaemic and Cytopenic (Leukopenia, Thrombocytopenia) Haematological Disorders


Inclusion Criteria:



1. A diagnosis of MDS, AA, MF or thal based on currently recognized diagnostic criteria.

2. 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

3. 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

4. Understand the trial nature of this treatment, agree to be compliant to medication,
do not self medicate and have signed informed consent

5. Agreeable to regular blood tests and follow up marrow study as listed in schedule

Exclusion Criteria:

1. Life expectancy of shorter than one year

2. Significant organ failure including the following

3. Renal impairment with Cr above 200umol/L

4. Liver impairment with serum bilirubin > 2x upper limits or transaminase >3x upper
limits

5. 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

6. Women during pregnancy or lactation.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Outcome Description:

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

Outcome Time Frame:

6 months

Safety Issue:

Yes

Authority:

Singapore: Domain Specific Review Boards

Study ID:

SHF/TCM002/2008

NCT ID:

NCT01224496

Start Date:

July 2009

Completion Date:

August 2011

Related Keywords:

  • Myelodysplastic Syndrome (MDS)
  • Aplastic Anaemia (AA)
  • Myelofibrosis (MF)
  • Thalassemia Intermedia
  • Chronic cytopenic haematological diseases
  • Chinese herbal concoction
  • Supportive management
  • Primary Myelofibrosis
  • Anemia
  • Anemia, Aplastic
  • Beta-Thalassemia
  • Hematologic Diseases
  • Leukopenia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Thalassemia
  • Thrombocytopenia

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