Trial Outcomes & Findings for Study of 5-azacitidine in Combination With Vorinostat in Patients With Relapsed or Refractory Diffuse Large b Cell Lymphoma (DLBCL) (NCT NCT01120834)

Last Updated: 2017-04-10

Results Overview

Overall Response Rate (ORR)

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

17 participants

Primary outcome timeframe

2 cycles

Results posted on

2017-04-10

Participant milestones
Measure	All Subjects azacytidine: • Dose level 1: azacitidine 55 mg/m2 on days 1-5 * Dose level 2: azacitidine 75 mg/m2 on days 1-5 * Dose level 3: azacitidine 55 mg/m2 on days 1-5 * Dose level 4: azacitidine 75 mg/m2 on days 1-5 Each cycle = 28 days. Subjects may receive up to 6 cycles. vorinostat: • Dose level 1: oral vorinostat at 300 mg BID on Days 1-7. * Dose level 2: oral vorinostat at 200 mg BID on Days 1-7. * Dose level 3: oral vorinostat at 300 mg BID on Days 1-14. * Dose level 4: oral vorinostat at 200 mg BID on Days 1-14. Each cycle = 28 days. Subjects receive up to 6 cycles.
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Study of 5-azacitidine in Combination With Vorinostat in Patients With Relapsed or Refractory Diffuse Large b Cell Lymphoma (DLBCL)

Baseline characteristics by cohort
Measure	All Subjects n=18 Participants azacytidine: • Dose level 1: azacitidine 55 mg/m2 on days 1-5 * Dose level 2: azacitidine 75 mg/m2 on days 1-5 * Dose level 3: azacitidine 55 mg/m2 on days 1-5 * Dose level 4: azacitidine 75 mg/m2 on days 1-5 Each cycle = 28 days. Subjects may receive up to 6 cycles. vorinostat: • Dose level 1: oral vorinostat at 300 mg BID on Days 1-7. * Dose level 2: oral vorinostat at 200 mg BID on Days 1-7. * Dose level 3: oral vorinostat at 300 mg BID on Days 1-14. * Dose level 4: oral vorinostat at 200 mg BID on Days 1-14. Each cycle = 28 days. Subjects receive up to 6 cycles.
Age, Continuous	66.5 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants

Timeframe: 2 cycles

Overall Response Rate (ORR)

Outcome measures
Measure	All Subjects n=15 Participants
Overall Response Rate (ORR)	1 Participants

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	All Subjects n=18 participants at risk all subjects
Blood and lymphatic system disorders anemia	77.8% 14/18
Blood and lymphatic system disorders thrombocytopenia	33.3% 6/18
Blood and lymphatic system disorders leucopenia	27.8% 5/18
Blood and lymphatic system disorders neutropenia	11.1% 2/18
General disorders nausea	66.7% 12/18
Blood and lymphatic system disorders hypoglycemia	38.9% 7/18
Renal and urinary disorders renal impairment	38.9% 7/18
Gastrointestinal disorders diarrhea	33.3% 6/18
General disorders vomiting	33.3% 6/18
Blood and lymphatic system disorders raised ALP	27.8% 5/18
Blood and lymphatic system disorders hyperglycemia	27.8% 5/18
General disorders fatigue	22.2% 4/18
General disorders fever	16.7% 3/18
Blood and lymphatic system disorders hyperbilirubinemia	16.7% 3/18

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