Rollover study supporting hematological disorder indications from Celgene sponsored CC-486 (oral azacitidine) protocols eligible for participation in the study.
The open-label, multicenter, multinational rollover study is intended to evaluate the safety of CC-486 (oral azacitidine), while providing continued treatment with CC-486 for subjects who are receiving single agent CC-486 at the time of transition to the rollover study and tolerated the protocol prescribed regimen in Celgene-sponsored trials, and whom in the opinion of the Investigator may derive clinical benefit from continuing treatment with CC-486. Subjects' survival will also be followed if required by the parent CC-486 study protocol. If approved by Celgene, subjects from any ongoing or future Celgene sponsored CC-486 studies in hematological disorders will be included in this protocol.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
The subject will continue at the same dose, frequency and schedule used for the last dose of CC-486 given in the preceding CC-486 study. Subjects are allowed to rollover after the last cycle is finished and before the new cycle begins in the parent protocol. There is a 7 day window from End of Study on the parent protocol and when the participant will start Day 1 of the rollover study.
Local Institution - 101
Gainesville, Florida, United States
Local Institution - 103
Baltimore, Maryland, United States
Local Institution - 102
Houston, Texas, United States
Manchester Royal Infirmary
Manchester, United Kingdom
Number of Participants With Treatment Emergent Adverse Events
A treatment emergent adverse event is any untoward medical occurrence that begins or worsens after the first dose of study treatment, including any unfavorable sign, symptom, disease, or abnormal lab finding, whether or not related to the product, and may include worsening of pre-existing conditions. A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is considered an important medical event requiring intervention to prevent these outcomes.
Time frame: From informed consent signed (Day 1) and until 28 days after the last dose of CC-486, or until the treatment discontinuation visit, whichever was later (up to approximately 90 months)
Number of Participants Who Survived
Time frame: From informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
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