A Phase 2 interventional study of Azacitidine in Myelodysplastic Syndrome, sponsored by Seoul St. Mary's Hospital. Status unknown at 3 sites in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-11-20.
Sponsored by Seoul St. Mary's Hospital · Phase 2, Interventional, and Treatment
Approved dosing schedule of azacitidine for myelodysplastic syndrome (MDS) is 75 mg/m\^2/day subcutaneous for 7 consecutive days every 28 days, which is based on the data from standard chemotherapy regimen and a Phase I safety clinical trial. Since the optimal dosage of this drug has not been found yet, it remains as a subject of clinical study that needs to be examined. If initial toxicity is minimized by developing dosage/regimen that replaces the standard therapy, it will be possible to provide continuous treatment with increased convenience by patients and treating physicians as well as improvement for safety in elderly patients or those with serious cytopenia. In addition, it is expected to lead to a better response by strictly keeping a treatment schedule.
Recent US study showed that 5-day regimen showed similar treatment results, but retrospective data from Spain showed lower response rate in 5-day regimen. Considering the recent circumstances around dosage and schedule of azacitidine in lower risk MDS, a Phase II clinical trial is planned in lower risk MDS patients in order to explore the efficacy in 5-day treatment by comparing prospectively with 7-day standard regimen.
Using block randomization, subjects of Low or intermediate (INT)-1 patients will be equally allocated to the following two types of regimens.
1,317 studies on the registry are indexed under Preleukemia; 57 are open to participants now.
This study's planned enrollment of 92 is above the median of 36 across 1,060 interventional studies indexed under Preleukemia.
Browse Preleukemia studies →Seoul St. Mary's Hospital is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
azacitidine 75mg/m2 subcutaneously for 7 days every 28 days + best supportive care
Drug: Azacitidine
azacitidine 75mg/m2 subcutaneously for 5 days every 28 days + best supportive care
Drug: Azacitidine
5-day arm: azacitidine 75mg/m2 subcutaneously for 7 days every 28 days + best supportive care 7-day arm: azacitidine 75mg/m2 subcutaneously for 5 days every 28 days + best supportive care
Also known as: vidaza
Overall response rate by modified IWG 2006 response criteria
Overall response rate is evaluated by assessing the percentage of patients with response (complete remission (CR), partial remission (PR), bone marrow CR, and hematologic improvement), response period, and transfusion requirement. Best response during at least 6 cycles of treatment will be assessed if there is no treatment failure or disease progression within 6 cycles of treatment. For patients who can keep the 4 week interval the Time Frame will be 25 weeks. The cycle interval can be extended up to 8 weeks which makes 49 weeks the maximum Time Frame.
Time frame: After 6 cycles of treatment up to 25-49 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
•Safety and tolerability profile of 5-day azacitidine in comparison with 7-day regimen. For patients who can keep the 4 week interval the Time Frame will be 25 weeks. The cycle interval can be extended up to 8 weeks which makes 49 weeks the maximum Time Frame.
Time frame: After each course of treatment up to 25-49 weeks
Cytogenetic response rate by IWG 2006 response criteria
•Cytogenetic response of of 5-day azacitidine in comparison with 7-day regimen. For patients who can keep the 4 week interval the Time Frame will be 25 weeks. The cycle interval can be extended up to 8 weeks which makes 49 weeks the maximum Time Frame.
Time frame: After 6 cycles of treatment up to 25-49 weeks
This study is status unknown, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Seoul St. Mary's Hospital