Conditions: Myelodysplastic Syndromes Secondary Acute Myeloid Leukemia (AML)
Keywords: Previously treated MDS oral clofarabine Intermediate-1, Intermediate-2 and High Risk MDS secondary AML (with history of MDS)
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 38
Healthy volunteers: no

Brief summary:
There was no well accepted standard of care for participants who failed or were intolerant to any of the currently approved therapies for myelodysplastic syndromes (MDS). In this study, participants were initially assigned to receive 55 or 35 milligrams (mg) of oral clofarabine daily for 5 days. After safety review of the first participants enrolled, the dose was reduced to 25 milligrams per day (mg/day) for up to 8 cycles as long as the participants continued to benefit and in the absence of progressive disease.

Detailed description:

Arms:
arm 1: Participants received Clofarabine 55 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years). arm 2: Participants received Clofarabine 35 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years). arm 3: Participants received Clofarabine 25 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years).

Interventions: intervention 1: Clofarabine
Intervention descriptions: intervention 1: Pharmaceutical form: Tablet,

Route of administration: Oral

Protocol document: