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Trial record 63 of 881 for:    "Reticulum Cell Sarcoma"

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

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ClinicalTrials.gov Identifier: NCT01686165
Recruitment Status : Completed
First Posted : September 17, 2012
Results First Posted : July 31, 2018
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Arizona

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Anaplastic Large Cell Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Mantle Cell Lymphoma
Interventions Drug: belinostat
Biological: rituximab
Radiation: yttrium Y 90 ibritumomab tiuxetan
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle
Hide Arm/Group Description 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 Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  40.0%
>=65 years
3
  60.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
1
  20.0%
Male
4
  80.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
5
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Complete Response Rate
Hide Description 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.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle
Hide Arm/Group Description:
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 Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Primary Outcome
Title Overall Response
Hide Description 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.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle
Hide Arm/Group Description:
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 Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Progression-free Survival
Hide Description 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.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle
Hide Arm/Group Description:
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 Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4.Secondary Outcome
Title Occurrence of Adverse Events and Serious Adverse Events
Hide Description The proportion of patients with a given adverse event will be tabulated and the 95% confidence interval computed.
Time Frame Up to 30 days after patient receives last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle
Hide Arm/Group Description:
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 Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
5
 100.0%
Time Frame Three years, six months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle
Hide Arm/Group Description 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.
All-Cause Mortality
PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle
Affected / at Risk (%)
Total   1/5 (20.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle
Affected / at Risk (%) # Events
Total   1/5 (20.00%)    
Blood and lymphatic system disorders   
Deep Venous Thrombosis   1/5 (20.00%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PXD-101 (d1-d5) for 2 Cycles > Zevalin 1 Cycle
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Blood and lymphatic system disorders   
Thrombocytopenia   3/5 (60.00%) 
Increased Serum Creatinine   2/5 (40.00%) 
Hypoalbuminemia   1/5 (20.00%) 
Ear and labyrinth disorders   
Otitis Media   1/5 (20.00%) 
Tinnitus   1/5 (20.00%) 
Endocrine disorders   
Hypoglycemia   1/5 (20.00%) 
Eye disorders   
Blurred Vision   1/5 (20.00%) 
Gastrointestinal disorders   
Nausea/Vomiting   4/5 (80.00%) 
General disorders   
Pain   3/5 (60.00%) 
Fatigue   1/5 (20.00%) 
Hepatobiliary disorders   
Transaminitis   1/5 (20.00%) 
Nervous system disorders   
Sensory Neuropathy   2/5 (40.00%) 
Dizziness   1/5 (20.00%) 
Vascular disorders   
Edema - lower extremity   2/5 (40.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Daniel Persky, M.D.
Organization: University of Arizona Cancer Center
Phone: 520-626-8908
EMail: dpersky@uacc.arizona.edu
Layout table for additonal information
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT01686165     History of Changes
Other Study ID Numbers: 12-0288-04
NCI-2012-01131 ( Other Identifier: CTRP (Clinical Trial Reporting Program) )
1200000288 ( Other Identifier: UofA IRB # )
P30CA023074 ( U.S. NIH Grant/Contract )
First Submitted: September 12, 2012
First Posted: September 17, 2012
Results First Submitted: July 2, 2018
Results First Posted: July 31, 2018
Last Update Posted: August 28, 2018