Trial Outcomes & Findings for Pilot Study of Brentuximab Vedotin in Relapsed/Refractory Peripheral T-Cell Lymphoma Expressing CD30 (NCT NCT01841021)

Last Updated: 2017-01-19

Results Overview

ORR: The proportion of patients with complete response (CR) and partial response (PR). Follow-up assessments after cycle 16 to be done every 12 weeks for up to 24 months. Restaging imaging computed tomography (CT) scans to be repeated 12 and 24 months from the beginning of the follow-up period. Objective disease response (CR and PR) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL). CR = Disappearance of all evidence of disease; PR = Regression of measurable disease and no new sites.

Recruitment status

TERMINATED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

Up to 24 months post treatment

Results posted on

2017-01-19

Participant Flow

One participant was enrolled in June 2015 at Moffitt Cancer Center. Soon after the accrual of this one participant, the sponsor terminated their support of the project.

Participant milestones

Participant milestones
Measure	Brentuximab Vedotin Treatment Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of Brentuximab Vedotin in Relapsed/Refractory Peripheral T-Cell Lymphoma Expressing CD30

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brentuximab Vedotin Treatment n=1 Participants Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	68 (MEAN) n=5 Participants
Gender Female	1 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 months post treatment

Population: All participants.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin Treatment n=1 Participants Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
Overall Response Rate (ORR) Participants with Complete Response	0 Participants
Overall Response Rate (ORR) Participants with Partial Response	0 Participants
Overall Response Rate (ORR) Participants with Stable Disease	1 Participants

SECONDARY outcome

Timeframe: Up to 24 months post treatment

Population: Participants with Complete Response or Partial Response.

Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. TTR: The time from the start of treatment to the first time when the measurement criteria for CR or PR are met. Participants who did not have a confirmed response to be censored at the date of the last tumor assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months post treatment

Population: Participants with Complete Response or Partial Response.

DOR: The number of days between the first tumor response assessment of objective response (complete response and partial response) to the time of the first tumor response assessment of progressive disease (PD) or death if due to disease progression (date of first PD assessment or death due to disease progression-date of first objective response assessment +1).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months post treatment

Population: All participants.

Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. Progressive disease (PD) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL).

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin Treatment n=1 Participants Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
Time to Disease Progression (TTP)	10 months

SECONDARY outcome

Timeframe: 24 months post treatment

Population: Participants evaluable at 24 months post treatment.

Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. Stable disease (SD) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months post treatment or until study closure

Population: Participants evaluable at 24 months post treatment or at study closure.

Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. Radiological assessments to be discontinued at the time of tumor progression or initiation of new anticancer therapy, after which survival to be evaluated every 3 months until 2 years from the start of study treatment or until study closure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months post treatment

Population: All participants.

Serious adverse events (SAEs) to be summarized by worst NCI NCI Common Terminology Criteria for Adverse Events (CTCAE) grade.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin Treatment n=1 Participants Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
Number of Participants With Study Related Serious Adverse Events (SAEs)	0 Participants

Adverse Events

Brentuximab Vedotin Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Brentuximab Vedotin Treatment n=1 participants at risk Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
Blood and lymphatic system disorders Anemia	100.0% 1/1 • Number of events 4 • 11 months
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	100.0% 1/1 • Number of events 3 • 11 months
Gastrointestinal disorders Diarrhea	100.0% 1/1 • Number of events 1 • 11 months
Gastrointestinal disorders Gastrointestinal disorders - Other	100.0% 1/1 • Number of events 1 • 11 months
General disorders Fever	100.0% 1/1 • Number of events 2 • 11 months
General disorders Infusion related reaction	100.0% 1/1 • Number of events 4 • 11 months
Investigations Investigations - Other	100.0% 1/1 • Number of events 2 • 11 months
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other	100.0% 1/1 • Number of events 2 • 11 months
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	100.0% 1/1 • Number of events 1 • 11 months
Nervous system disorders Nervous system disorders - Other	100.0% 1/1 • Number of events 3 • 11 months
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	100.0% 1/1 • Number of events 2 • 11 months
Skin and subcutaneous tissue disorders Rash maculo-papular	100.0% 1/1 • Number of events 1 • 11 months
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	100.0% 1/1 • Number of events 1 • 11 months
Vascular disorders Vascular disorders - Other	100.0% 1/1 • Number of events 1 • 11 months

Additional Information

Dr. Lubomir Sokol

H. Lee Moffitt Cancer Center and Research Institute

Phone: 813-745-8212

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place