Pilot Study of CC 486 (Oral Azacitidine) Plus BSC as Maintenance After sc Azacitidine in Elderly HR-IPSS-R MDS Patients
Status:
Recruiting
Trial end date:
2024-07-01
Target enrollment:
Participant gender:
Summary
Treatment of higher-risk (intermediate, high and very high) Myelodysplastic Syndromes (MDS)
according to the revised International Prognostic Scoring System (IPSS-R) who obtained a
stable hematological response ( CR, PR) after subcutaneous azacitidine treatment.
Azacitidine is administered in hospital in a day care regimen, in Italy only by subcutaneous
injection. The long duration of therapy obliges patients to travel to the hospital regularly,
with evident worsening quality of life, both for patients and caregivers, although balanced
by prolongation of survival and hematological improvement. Many patients stop therapy or are
reluctant to continue because of the dependence from caregivers and hospital care.
This clinical study will evaluate the efficacy and safety of oral azacitidine (CC-486) plus
best supportive care in subjects with higher-risk (intermediate, high and very high)
Myelodysplastic Syndrome (MDS) according to the revised International Prognostic Scoring
System (IPSS-R) and (high and INT-2) according to IPSS who obtained a stable hematological
response (CR, PR, SD with HI) after at least 4-6 cycles of subcutaneous azacitidine treatment
and maintained for 2 additional cycles.