nil
ACTRN12607000283471
Treatment
Phase 1 / Phase 2
Commercial sector/Industry,Pharmion Australia
Dr Melita Kenealy
5-azacitidine, a demethylating agent, has been approved for use in USA for treatment of Myelodysplastic Syndromes (MDS), with overall response rates of approximately 48%, a delay to progression to acute leukaemia or death and an improvement in quality of life. Thalidomide has also shown some activity as a single agent in MDS though with poor tolerance at doses above 100mg/day. Neither of these agents is currently routinely available in Australia for MDS. This trial aims to show the safety and to .... Read more
1. Subjects with myelodysplastic syndrome (MDS), either de novo or treatment related 2. patients with refractory anaemia or refractory anaemia with ringed sideroblasts to meet one of the following additional criteria of marrow dysfunction:a. transfusion dependent or symptomatic anemia up to 3 monthsb. clinically significant thrombocytopenia; either significant bleeding, platelet transfusion dependency or thrombocytopenia with at least two counts less than or equal to 50x109/L at least 1 month ap .... Read more
1. bone marrow blast count 30% or more2. Grade 3-4 peripheral neuropathy3. prior stem cell transplantation4. prior treatment with thalidomide or its analogues within 30 days of commencing treatment on trial5. any prior treatment with 5-azacitidine, decitabine or any known demethylating agent6. treatment with Granulocyte colony stimulating factor in the 21 days prior to Day 1, androgenic hormones in 14 days prior to Day 1 or any investigational agent in the 30 days prior to Day 17. any serious me .... Read more
No
Sample Size 80
Min. age 18 Years
Max. age -2147483648 No limit
Sex Both males and females
Condition category Myelodysplastic Syndromes
Condition code Blood
Intervention code Treatment: Drugs
All participants will receive both 5-azacitidine and thalidomide: 1. 5-azacitidine subcutaneous injection 75mg/m2/d for 7 days every 28 days for up to 24 cycles 2. Thalidomide orally commencing at 50mg/day, increasing to a maximum 100mg/day continuous treatment for up to 12 months
Control group Uncontrolled
-
Outcome: Haematologic and Non-haematologic toxicity of the combination of thalidomide and 5-azacitidine.Timepoint: Toxicities are measured as they occur throughout the study period.
yes
De-identified IPD data, for all data collected during the trial
Data available 3 months following publication, for an indefinite period
Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations • Other Based in: • Any location Further information: All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
Any type of analysis Assessed on a case-by-case basis