Trial Outcomes & Findings for Combination of Vorinostat and Bortezomib in Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma (NCT NCT00810576)

Results Overview

Computed tomography scans and/or Positron emission tomography (PET) scans obtained every two cycles to evaluate response using International Workshop Criteria of Complete Response, Partial Response, Progressive Disease, or Stable Disease.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Every two 21-day cycles

Results posted on

2012-08-07

Participant Flow

Recruitment Period: 02/17/09 through 04/26/10. All participants recruited at UT MD Anderson Cancer Center.

Trial terminated due to slow accrual, only 1 patient registered.

Participant milestones

Participant milestones
Measure	Vorinostat + Bortezomib Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m\^2 intravenously on Days 1, 4, 8, 11.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combination of Vorinostat and Bortezomib in Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vorinostat + Bortezomib n=1 Participants Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m\^2 intravenously on Days 1, 4, 8, 11.
Age Continuous	48 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Every two 21-day cycles

Population: No analysis done due to early termination resulting from low accrual.

Computed tomography scans and/or Positron emission tomography (PET) scans obtained every two cycles to evaluate response using International Workshop Criteria of Complete Response, Partial Response, Progressive Disease, or Stable Disease.

Outcome measures

Outcome measures
Measure	Vorinostat + Bortezomib n=1 Participants Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m\^2 intravenously on Days 1, 4, 8, 11.
Number of Patients With Response Complete Response	0 participants
Number of Patients With Response Partial Response	0 participants
Number of Patients With Response Progressive Disease	1 participants
Number of Patients With Response Stable Disease	0 participants

Adverse Events

Vorinostat + Bortezomib

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Barbara Pro, MD

UT MD Anderson Cancer Center

Phone: 713-792-2933

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place