Trial Outcomes & Findings for Bortezomib in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (NCT NCT00182637)

NCT ID: NCT00182637

Last Updated: 2020-08-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: 2 months
• Results posted on: 2020-08-03

Participant Flow

Participant milestones

Measure	Bortezomib administration of bortezomib
Overall Study STARTED	5
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Bortezomib administration of bortezomib
Overall Study Adverse Event	2
Overall Study Disease Progression	1

Baseline Characteristics

Bortezomib in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma

Baseline characteristics by cohort

Measure	Bortezomib n=5 Participants administration of bortezomib
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months

Population: Only two subjects completed the trial. Study closed early due to lack of enrollment. No analysis performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Only two subjects completed the trial. Study closed early due to lack of enrollment. No analysis performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Only two subjects completed the trial. Study closed early due to lack of enrollment. No analysis performed.

Outcome measures

Outcome data not reported

Adverse Events

Bortezomib

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Bortezomib n=5 participants at risk administration of bortezomib
General disorders Fatigue	40.0% 2/5 • Number of events 2 • From the time that subjects signed consent until 30 days post treatment. Time frame varied depending on the time that the subject was on study. Approximately 6-7 months.
General disorders Decrease Appetite	20.0% 1/5 • Number of events 1 • From the time that subjects signed consent until 30 days post treatment. Time frame varied depending on the time that the subject was on study. Approximately 6-7 months.
General disorders Hot Flushes	20.0% 1/5 • Number of events 1 • From the time that subjects signed consent until 30 days post treatment. Time frame varied depending on the time that the subject was on study. Approximately 6-7 months.
Psychiatric disorders Depression	20.0% 1/5 • Number of events 1 • From the time that subjects signed consent until 30 days post treatment. Time frame varied depending on the time that the subject was on study. Approximately 6-7 months.
General disorders Insominia	20.0% 1/5 • Number of events 1 • From the time that subjects signed consent until 30 days post treatment. Time frame varied depending on the time that the subject was on study. Approximately 6-7 months.
Cardiac disorders Pain extremities, chest	20.0% 1/5 • Number of events 1 • From the time that subjects signed consent until 30 days post treatment. Time frame varied depending on the time that the subject was on study. Approximately 6-7 months.
General disorders neuropathy extremities	40.0% 2/5 • Number of events 3 • From the time that subjects signed consent until 30 days post treatment. Time frame varied depending on the time that the subject was on study. Approximately 6-7 months.
Respiratory, thoracic and mediastinal disorders asthma	20.0% 1/5 • Number of events 1 • From the time that subjects signed consent until 30 days post treatment. Time frame varied depending on the time that the subject was on study. Approximately 6-7 months.
Infections and infestations chills / cough cold symptoms	20.0% 1/5 • Number of events 1 • From the time that subjects signed consent until 30 days post treatment. Time frame varied depending on the time that the subject was on study. Approximately 6-7 months.
General disorders generalized itching	20.0% 1/5 • Number of events 2 • From the time that subjects signed consent until 30 days post treatment. Time frame varied depending on the time that the subject was on study. Approximately 6-7 months.
Infections and infestations Body Aches / Flu Symptoms	20.0% 1/5 • Number of events 1 • From the time that subjects signed consent until 30 days post treatment. Time frame varied depending on the time that the subject was on study. Approximately 6-7 months.
General disorders Sensitive Skin	20.0% 1/5 • Number of events 2 • From the time that subjects signed consent until 30 days post treatment. Time frame varied depending on the time that the subject was on study. Approximately 6-7 months.

Additional Information

Dr. Lauren Pinter-Brown

UC Irvine

Phone: (714) 456-5153

Email: lpinterb@uci.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place