Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
PNT2258-02: A Pilot Phase II Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
1 other identifier
interventional
13
1 country
3
Brief Summary
This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It study is a multi-center, nonrandomized, open-label, pilot Phase II investigation of PNT2258 to characterize anti-tumor activity and collect safety data on patients with relapsed or refractory lymphoma.
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 Nov 2012
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 20, 2012
CompletedFirst Posted
Study publicly available on registry
November 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
March 10, 2020
CompletedJune 22, 2023
June 1, 2023
3.8 years
November 20, 2012
February 25, 2020
June 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate
Subjects who had a best response of complete response or partial response as assessed by the investigator
39 months
Secondary Outcomes (1)
Progression-free Survival
39 months
Study Arms (1)
PNT2258
EXPERIMENTALPNT2258 120 mg/m2 will be administered as a 2-hour intravenous infusion on days 1-5 of a 21-day cycle. Treatment may continue (unless there is disease progression or the occurrence of unacceptable toxicity) for a total of 6 cycles of therapy.
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent must be obtained from the patient.
- Participants must be ≥18 years of age.
- Morphologically confirmed diagnosis of non-Hodgkin's lymphoma (NHL).
- At least a single measureable tumor mass (long axis \> 1.5 cm).
- An FDG-PET positive baseline scan.
- a. A positive scan is defined per revised Cheson criteria as "focal or diffuse FDG uptake above background in a location incompatible with normal anatomy or physiology, without a specific standardized uptake value cutoff".
- Disease that has relapsed after administration of primary therapy that included:
- Rituximab and
- CHOP, EPOCH, bendamustine or similar chemotherapy or subsequent salvage regimen.
- Note: Relapse is defined as progression after a complete response to therapy or radiographic evidence of active disease after a partial response or stable disease.
- Have received three or fewer complete courses of systemic cytotoxic regimens. Note: Rituximab (alone or in combination with cytotoxic chemotherapy) is not considered a cytotoxic regimen.
- No previous exposure to PNT2258.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Have discontinued all prior anti-cancer therapies for at least 21 days; biologic therapy for at least 4 half-lives of the drug(s); radio-immunotherapy (10 weeks); autologous stem cell transplantation (SCT) (3 months) and must be at a stable baseline regarding any acute toxicity associated with prior therapy.
- Adequate organ function including:
- +3 more criteria
You may not qualify if:
- Candidates for HDT and autologous SCT. Note: Patients who progressed \> 3 months after high-dose therapy (HDT)/SCT are eligible.
- Concurrent malignancies requiring treatment.
- Symptomatic central nervous system (CNS) or leptomeningeal involvement of lymphoma.
- Concurrent serious medical conditions (as determined by the Principal Investigator) including, but not limited to, HIV-associated lymphoma; active bacterial, fungal or viral infections.
- Signs and symptoms of heart failure characterized as greater than New York Heart Association (NYHA) Class I.
- History of myocardial infarct or prolonged corrected QT (QTc) interval (\>450 milliseconds (msecs) for males or \>470 msecs for females) or other significant cardiac abnormalities.
- Women who are pregnant or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Horizon Oncology Research, Inc.
Lafayette, Indiana, 47905, United States
Cancer and Hematology Centers of Western Michigan, P.C.
Grand Rapids, Michigan, 49503, United States
St. John Hospital and Medical Center, Van Elslander Cancer Center
Grosse Pointe Woods, Michigan, 48236, United States
Related Publications (1)
Harb W, Lakhani NJ, Messmann R, Klencke B, Al-Katib AM. A Phase 2 Study of PNT2258 for Treatment of Relapsed or Refractory B-Cell Malignancies. Clin Lymphoma Myeloma Leuk. 2021 Dec;21(12):823-830. doi: 10.1016/j.clml.2021.07.016. Epub 2021 Jul 23.
PMID: 34417162DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY CHAIR
Barbara Klencke, M.D.
Sierra Oncology LLC - a GSK company
- PRINCIPAL INVESTIGATOR
Ayad Al-Katib, MD
St. John Hospital and Medical Center, Van Elslander Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2012
First Posted
November 26, 2012
Study Start
November 1, 2012
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
June 22, 2023
Results First Posted
March 10, 2020
Record last verified: 2023-06