PNT2258 for Treatment of Patients With Richter's Transformation (Brighton)

Stopped early · Phase 2

Conditions studied: Richter's Transformation

In brief

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.

Key facts

Study ID

NCT02378038

Run by

Sierra Oncology LLC - a GSK company

People needed

5

Starts

2015-08-01

Expected to finish

2016-06-01

Last updated by the study team

2023-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• UC Irvine Medical Center — Orange, California, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• University of Pennsylvania, Abramson Cancer Center — Philadelphia, Pennsylvania, United States
• Tyler Hematology Oncology — Tyler, Texas, United States
• Swedish Cancer Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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