Trial Outcomes & Findings for Vorinostat and Pegylated Liposomal Doxorubicin in Relapsed or Refractory Lymphomas (NCT NCT00785798)

Results Overview

number of patients responding

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

17 participants

Primary outcome timeframe

end of study (up to 2 years)

Results posted on

2022-04-04

Participant milestones
Measure	Vorinostat and Pegylated Liposomal Doxorubicin Intervention Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle Vorinostat : 200mg to 400 mg twice daily on days 1-7
Overall Study STARTED	17
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	1

Withdrawal data not reported

Vorinostat and Pegylated Liposomal Doxorubicin in Relapsed or Refractory Lymphomas

Baseline characteristics by cohort
Measure	Vorinostat and Pegylated Liposomal Doxorubicin Intervention n=17 Participants Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle Vorinostat : 200mg to 400 mg twice daily on days 1-7
Age, Continuous	56.6 years STANDARD_DEVIATION 19.0 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

Timeframe: end of study (up to 2 years)

number of patients responding

Outcome measures
Measure	Vorinostat and Pegylated Liposomal Doxorubicin Intervention n=17 Participants Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle Vorinostat : 200mg to 400 mg twice daily on days 1-7
Overall Response Rate	17 Participants

Timeframe: 2 years

Number of patients with greater than 20% worsening in measurable disease by RECIST criteria

Outcome measures
Measure	Vorinostat and Pegylated Liposomal Doxorubicin Intervention n=17 Participants Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle Vorinostat : 200mg to 400 mg twice daily on days 1-7
Number of Subjects With Progressive Disease (PR)	10 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Yale University School of Medicine