Trial Outcomes & Findings for Belinostat and Yttrium Y 90 Ibritumomab Tiuxetan in Patients W/Relapsed Aggressive B-Cell NHL (NCT NCT01686165)

Last Updated: 2018-08-28

Results Overview

To document the complete response rate for patients with relapsed aggressive high-risk non-Hodgkin's lymphoma (NHL) treated with two cycles PXD-101 followed by one cycle of the Zevalin regimen.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2018-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle Treatment with PXD101 will be administered intravenously\\ at a dose of 1,000 mg/m2 IV days 1-5 every 21 days for 2 cycles. Yttrium-90 ibritumomab tiuxetan (Zevalin®) Administration. Y-90 Zevalin will be administered to all subjects in accordance with the approved Zevalin product labeling. Treatment will be administered on an outpatient basis.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Belinostat and Yttrium Y 90 Ibritumomab Tiuxetan in Patients W/Relapsed Aggressive B-Cell NHL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle n=5 Participants Treatment with PXD101 will be administered intravenously\\ at a dose of 1,000 mg/m2 IV days 1-5 every 21 days for 2 cycles. Yttrium-90 ibritumomab tiuxetan (Zevalin®) Administration. Y-90 Zevalin will be administered to all subjects in accordance with the approved Zevalin product labeling. Treatment will be administered on an outpatient basis.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	4 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	0 Participants n=5 Participants
Race (NIH/OMB) White	5 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: Up to 5 years

To document the complete response rate for patients with relapsed aggressive high-risk non-Hodgkin's lymphoma (NHL) treated with two cycles PXD-101 followed by one cycle of the Zevalin regimen.

Outcome measures

Outcome measures
Measure	PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle n=5 Participants Treatment with PXD101 will be administered intravenously\\ at a dose of 1,000 mg/m2 IV days 1-5 every 21 days for 2 cycles. Yttrium-90 ibritumomab tiuxetan (Zevalin®) Administration. Y-90 Zevalin will be administered to all subjects in accordance with the approved Zevalin product labeling. Treatment will be administered on an outpatient basis.
Complete Response Rate	0 Participants

PRIMARY outcome

Timeframe: Up to 5 years

To document the overall response for patients with relapsed aggressive high-risk non-Hodgkin's lymphoma (NHL) treated with two cycles PXD-101 followed by one cycle of the Zevalin regimen.

Outcome measures

Outcome measures
Measure	PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle n=5 Participants Treatment with PXD101 will be administered intravenously\\ at a dose of 1,000 mg/m2 IV days 1-5 every 21 days for 2 cycles. Yttrium-90 ibritumomab tiuxetan (Zevalin®) Administration. Y-90 Zevalin will be administered to all subjects in accordance with the approved Zevalin product labeling. Treatment will be administered on an outpatient basis.
Overall Response	0 Participants

SECONDARY outcome

Timeframe: 2 years

Will be estimated using a Kaplan-Meier estimate. The observed 2-year progression-free survival rate will be estimated (with a 95% confidence interval) from the Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle n=5 Participants Treatment with PXD101 will be administered intravenously\\ at a dose of 1,000 mg/m2 IV days 1-5 every 21 days for 2 cycles. Yttrium-90 ibritumomab tiuxetan (Zevalin®) Administration. Y-90 Zevalin will be administered to all subjects in accordance with the approved Zevalin product labeling. Treatment will be administered on an outpatient basis.
Progression-free Survival	0 Participants

SECONDARY outcome

Timeframe: Up to 30 days after patient receives last dose of study drug

The proportion of patients with a given adverse event will be tabulated and the 95% confidence interval computed.

Outcome measures

Outcome measures
Measure	PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle n=5 Participants Treatment with PXD101 will be administered intravenously\\ at a dose of 1,000 mg/m2 IV days 1-5 every 21 days for 2 cycles. Yttrium-90 ibritumomab tiuxetan (Zevalin®) Administration. Y-90 Zevalin will be administered to all subjects in accordance with the approved Zevalin product labeling. Treatment will be administered on an outpatient basis.
Occurrence of Adverse Events and Serious Adverse Events	5 Participants

Adverse Events

PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle

Serious events: 1 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle n=5 participants at risk Treatment with PXD101 will be administered intravenously\\ at a dose of 1,000 mg/m2 IV days 1-5 every 21 days for 2 cycles. Yttrium-90 ibritumomab tiuxetan (Zevalin®) Administration. Y-90 Zevalin will be administered to all subjects in accordance with the approved Zevalin product labeling. Treatment will be administered on an outpatient basis.
Blood and lymphatic system disorders Deep Venous Thrombosis	20.0% 1/5 • Number of events 1 • Three years, six months.

Other adverse events

Other adverse events
Measure	PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle n=5 participants at risk Treatment with PXD101 will be administered intravenously\\ at a dose of 1,000 mg/m2 IV days 1-5 every 21 days for 2 cycles. Yttrium-90 ibritumomab tiuxetan (Zevalin®) Administration. Y-90 Zevalin will be administered to all subjects in accordance with the approved Zevalin product labeling. Treatment will be administered on an outpatient basis.
Gastrointestinal disorders Nausea/Vomiting	80.0% 4/5 • Three years, six months.
Blood and lymphatic system disorders Thrombocytopenia	60.0% 3/5 • Three years, six months.
General disorders Pain	60.0% 3/5 • Three years, six months.
Vascular disorders Edema - lower extremity	40.0% 2/5 • Three years, six months.
Blood and lymphatic system disorders Increased Serum Creatinine	40.0% 2/5 • Three years, six months.
Nervous system disorders Sensory Neuropathy	40.0% 2/5 • Three years, six months.
Endocrine disorders Hypoglycemia	20.0% 1/5 • Three years, six months.
Eye disorders Blurred Vision	20.0% 1/5 • Three years, six months.
Nervous system disorders Dizziness	20.0% 1/5 • Three years, six months.
General disorders Fatigue	20.0% 1/5 • Three years, six months.
Blood and lymphatic system disorders Hypoalbuminemia	20.0% 1/5 • Three years, six months.
Ear and labyrinth disorders Otitis Media	20.0% 1/5 • Three years, six months.
Ear and labyrinth disorders Tinnitus	20.0% 1/5 • Three years, six months.
Hepatobiliary disorders Transaminitis	20.0% 1/5 • Three years, six months.

Additional Information

Daniel Persky, M.D.

University of Arizona Cancer Center

Phone: 520-626-8908

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place