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PNT2258 for Treatment of Patients With Richter's Transformation (Brighton) | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

A Phase II Study of PNT2258 in Patients With Richter's Transformation (RT)

NCT02378038•Sierra Oncology LLC - a GSK company

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically confirmed Richter's transformation (RT) from chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
•2. Availability of fresh or archived tumor tissue.
•3. FDG PET-CT (disease) positive baseline scan with measurable disease.
•4. ECOG performance status of 0-1.
•5. Evidence of disease progression at study entry.
•6. 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.
•7. 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.
•8. Adequate bone marrow, renal, and hepatic function.
•9. Normal Coagulation profile.
+2 more criteria

Exclusion Criteria

•1. Concurrent non-hematologic malignancies requiring treatment.
•2. No more than 2 prior regimens for DLBCL.
•3. Hodgkin's variant of Richter's lymphoma, accelerated CLL, composite lymphoma, interdigitating dendritic cell sarcoma, sarcoma, EBV-associated lymphoma or prolymphocytic transformation.
•4. Ongoing risk of bleeding.
•5. CNS or leptomeningeal involvement of lymphoma
•6. 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.
•7. Pregnancy or breast-feeding.
•8. Previous exposure to PNT2258.

Locations (9)

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

Key Dates

Start Date

August 1, 2015

Primary Completion Date

June 1, 2016

Completion Date

June 1, 2016

Last Updated

June 29, 2023

Enrollment

ACTUAL participants

Conditions

Richter's Transformation

Interventions

PNT2258

DRUG

ONO-4538 Study in Patients With Richter's Transformation

NCT06936943

Richter's Transformation

View study

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

A Study of Nemtabrutinib (MK-1026) in Participants With Relapsed or Refractory Hematologic Malignancies (ARQ 531-101/MK-1026-001)

NCT03162536

Lymphoma, B-CellSmall Lymphocytic Lymphoma+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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