PNT2258 for Treatment of Patients With Richter's Transformation (Brighton)
A Phase II Study of PNT2258 in Patients With Richter's Transformation (RT)
1 other identifier
interventional
5
1 country
9
Brief Summary
This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It is a multi-center, single-arm, 2-stage, open-label phase II investigation of PNT2258 to characterize anti-tumor activity and collect safety data on patients with Richter's Transformation.
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 2015
Shorter than P25 for phase_2
9 active sites
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
First Submitted
Initial submission to the registry
February 26, 2015
CompletedFirst Posted
Study publicly available on registry
March 4, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
March 10, 2020
CompletedJune 29, 2023
June 1, 2023
10 months
February 26, 2015
February 25, 2020
June 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate
Proportion of subjects with complete response (CR/CMR) or partial response (PR/PMR)
2 months
Secondary Outcomes (6)
Disease Control Rate
2 months
Duration of Overall Response
2 months
Time to Response
2 months
Progression Free Survival
2 months
Overall Survival
2 months
- +1 more secondary outcomes
Study Arms (1)
PNT2258
EXPERIMENTALPNT2258 will be administered at 120 mg/m2 on days 1-5 of a 21-day cycle for 8 induction cycles followed by continuation phase therapy at a dose of 100 mg/m2 on days 1-4 of a 28-day cycle.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed Richter's transformation (RT) from chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
- Availability of fresh or archived tumor tissue.
- FDG PET-CT (disease) positive baseline scan with measurable disease.
- ECOG performance status of 0-1.
- Evidence of disease progression at study entry.
- Discontinuation of prior anticancer therapy for ≥ 7 days prior to C1D1 and recovered to ≤ CTCAE grade 2 (or baseline) from any acute or chronic toxicity associated with prior therapy.
- Must have previously received at least one prior chemotherapeutic regimen for RT.
- \- Previously untreated RT patients deemed ineligible for, or that refuse, intensive chemotherapy are eligible.
- Adequate bone marrow, renal, and hepatic function.
- Normal Coagulation profile.
- Agreement to use acceptable methods of contraception during the study and for ≥ 120 days after the last dose of PNT2258 if sexually active and able to bear or beget children.
- Ability to participate in the clinical study for a minimum of at least 2 cycles (6 weeks).
You may not qualify if:
- Concurrent non-hematologic malignancies requiring treatment.
- No more than 2 prior regimens for DLBCL.
- Hodgkin's variant of Richter's lymphoma, accelerated CLL, composite lymphoma, interdigitating dendritic cell sarcoma, sarcoma, EBV-associated lymphoma or prolymphocytic transformation.
- Ongoing risk of bleeding.
- CNS or leptomeningeal involvement of lymphoma
- Concurrent clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram or laboratory finding that, in the opinion of the investigator, could adversely affect the safety of the subject or impair the assessment of the study results.
- Pregnancy or breast-feeding.
- Previous exposure to PNT2258.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
UC Irvine Medical Center
Orange, California, 92868, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Columbia University Medical Center
New York, New York, 10027, United States
Duke University
Durham, North Carolina, 27705, United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Tyler Hematology Oncology
Tyler, Texas, 75701, United States
Swedish Cancer Institute
Seattle, Washington, 98122, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Early termination of enrollment, and thus very few subjects were analyzed.
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY CHAIR
Barbara Klencke, MD
Sierra Oncology LLC - a GSK company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- 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
February 26, 2015
First Posted
March 4, 2015
Study Start
August 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
June 29, 2023
Results First Posted
March 10, 2020
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share