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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Singapore General Hospital
• Collaborators: Shanghai Yueyang Integrated Medicine Hospital; Singapore Bao Zhong Tang TCM Center

Criteria

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.