Belinostat and Yttrium Y 90 Ibritumomab Tiuxetan in Patients W/Relapsed Aggressive B-Cell NHL
A Phase II Exploratory Study of PXD-101(Belinostat) Followed by Zevalin in Patients With Relapsed Aggressive High-Risk Lymphoma
4 other identifiers
interventional
5
1 country
1
Brief Summary
This study looks at what effects (good and bad) a drug called PXD-101 (belinostat) in combination with the radioactive drug Zevalin (yttrium Y 90 ibritumomab tiuxetan) has on patients with relapsed aggressive (high-risk) non-Hodgkin lymphoma. Studies in the laboratory suggest that drugs such as PXD101 can act upon specific cancer cell processes to cause either death of the cancer cells or prevention of their growth. In human studies with a small number of patients with this lymphoma, PXD-101 has shown the ability to shrink and slow tumor growth. When Zevalin is delivered directly to the tumor, the lymphoma cells are destroyed and this may result in the disappearance of the tumor (remission)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2012
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 31, 2012
CompletedFirst Submitted
Initial submission to the registry
September 12, 2012
CompletedFirst Posted
Study publicly available on registry
September 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2017
CompletedResults Posted
Study results publicly available
July 31, 2018
CompletedAugust 28, 2018
July 1, 2018
3.4 years
September 12, 2012
July 2, 2018
July 30, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Complete Response Rate
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.
Up to 5 years
Overall Response
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.
Up to 5 years
Secondary Outcomes (2)
Progression-free Survival
2 years
Occurrence of Adverse Events and Serious Adverse Events
Up to 30 days after patient receives last dose of study drug
Study Arms (1)
Belinostat Yttrium Ibritumomab Tiuxetan
EXPERIMENTALPatients receive belinostat IV over 30-60 minutes on days 1-5. Treatment with belinostat repeats every 21 days for 2 courses. Patients then receive rituximab IV on days 1 and either 7, 8, or 9, and yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 50. Treatment continues in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- Biopsy confirmed, CD20 positive diffuse large B-cell lymphoma, primary mediastinal b-cell lymphoma, mantel cell lymphoma, transformed indolent lymphoma, high grade-B-cell lymphoma; AND bone marrow must show =\< 20% CD20+ B-cells with \>= 15% cellularity within 42 days of study registration
- Any stage disease
- Patients must have been previously treated:
- \>= 3rd line if bone marrow transplant (BMT) candidate OR
- \>= 2nd line if not BMT candidate OR
- \>= 2nd relapse for BMT candidate OR
- \>= 1st relapse for non- BMT candidate
- Must have a diagnostic quality CT scan of the chest, abdomen and pelvis OR baseline PET-CT scan performed within 28 days prior to registration
- Must have bidimensionally measurable disease with lesions at least 1.5 cm in one dimension ALL measurable disease must be assessed within 28 days of registration
- To determine prior drug regimens: radiation therapy counts as 1 treatment, BMT including induction counts as one treatment, radioimmunotherapy is not considered a chemotherapy regimen, rituximab alone is not considered a treatment; all prior therapy must have been completed at least 30 days prior to registration; patients should not have taken valproic acid, or any other histone deacetylase inhibitor (eg., vorinostat, romidepsin), for at least 30 days prior to registration; patients must have recovered from any toxicities related to therapies prior to registration
- No clinical evidence of CNS involvement by lymphoma, any lab (eg., LDH or radiographic tests performed to access CNS involvement must be negative and must be performed within 42 days prior to registration
- Unilateral or bilateral bone marrow biopsy performed within 42 days prior to registration
- Life expectancy of greater than 3 months
- Karnofsky performance status \>= 60%
- Leukocytes \>= 3,000/mcL
- +9 more criteria
You may not qualify if:
- Patients who have had chemotherapy or radiotherapy within 30 days (6 weeks for nitrosoureas or mitomycin C) prior to study screening or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Prior radioimmunotherapy
- Pregnant or nursing
- Clinical evidence of CNS involvement by lymphoma
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to PXD-101 or Zevalin or other agents used in the study
- Concomitant medication that may cause Torsade de Pointes, i.e. prolongation of the QT interval \> 500 msec
- Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure related to primary cardiac disease, any condition requiring anti-arrhythmic therapy, ischemic or valvular heart disease, or a myocardial infarction within the past 6 months
- Current long QT syndrome or baseline prolongation of QT/QTcF interval, i.e. demonstration of a QTcF interval \> 450 msec
- Clinical evidence of severe peripheral vascular disease, diabetic ulcers or venous stasis ulcers, or history of deep venous or arterial thrombosis within 3 months prior to screening
- Known to be human immunodeficiency virus (HIV) positive or with known acquired immunodeficiency syndrome (AIDS) syndrome
- Patients may not be receiving any other investigational agents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Arizonalead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Arizona Cancer Center
Tucson, Arizona, 85724-5024, United States
Related Publications (1)
Puvvada SD, Guillen-Rodriguez JM, Rivera XI, Heard K, Inclan L, Schmelz M, Schatz JH, Persky DO. A Phase II Exploratory Study of PXD-101 (Belinostat) Followed by Zevalin in Patients with Relapsed Aggressive High-Risk Lymphoma. Oncology. 2017;93(6):401-405. doi: 10.1159/000479230. Epub 2017 Sep 5.
PMID: 28869931DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Daniel Persky, M.D.
- Organization
- University of Arizona Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel O. Persky, MD
University of Arizona
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2012
First Posted
September 17, 2012
Study Start
August 31, 2012
Primary Completion
February 9, 2016
Study Completion
November 9, 2017
Last Updated
August 28, 2018
Results First Posted
July 31, 2018
Record last verified: 2018-07