Evaluating in Vivo AZA Incorporation in Mononuclear Cells Following Vidaza or CC486

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

May 18, 2018

Primary Completion Date

September 15, 2020

Study Completion Date

September 21, 2021

Conditions
Myelodysplastic SyndromesAcute Myeloid LeukemiaChronic Myelomonocytic Leukemia
Interventions
DRUG

Azacitidine

75mg/m2 per day for 7 days of each 28 day cycle. Cycles 1-6

DRUG

CC-486

100 mg BID for the first 21 days of each 28-day treatment cycle (cycles 7-8). The dose should be increased from cycle 9 onwards to 150mg BID for the first 21 days of each 28-day treatment cycle (cycles 9-12) in the absence of Grade 3 or 4 AE. If 2 or more cycles are tolerated at this dose, further increments are permitted for patients with Stable Disease or if clinically indicated in consultation with the coordinating investigator as per the study dose modification schedule.

Trial Locations (11)

219

Gosford and Wyong Hospitals, Sydney

2031

Prince of Wales Hospital, Sydney

2065

Royal North Shore Hospital, Sydney

2148

Blacktown Hospital, Sydney

2170

Liverpool Hospital, Sydney

2217

St George Hospital, Sydney

2298

Calvary Mater Newcastle, Newcastle

2500

Wollongong Hospital, Wollongong

2750

Nepean Hospital, Penrith

Unknown

Royal Prince Alfred Hospital, Sydney

St Vincent's hospital, Sydney

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Celgene

INDUSTRY

lead

Kirby Institute

OTHER_GOV

NCT03493646 - Evaluating in Vivo AZA Incorporation in Mononuclear Cells Following Vidaza or CC486 | Biotech Hunter | Biotech Hunter