PNT2258 for Treatment of Patients With Richter's Transformation (Brighton)
- Registration Number
- NCT02378038
- Lead Sponsor
- Sierra Oncology LLC - a GSK company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
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Histologically confirmed Richter's transformation (RT) from chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
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Availability of fresh or archived tumor tissue.
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FDG PET-CT (disease) positive baseline scan with measurable disease.
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ECOG performance status of 0-1.
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Evidence of disease progression at study entry.
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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.
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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.
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Adequate bone marrow, renal, and hepatic function.
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Normal Coagulation profile.
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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.
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Ability to participate in the clinical study for a minimum of at least 2 cycles (6 weeks).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PNT2258 PNT2258 PNT2258 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.
- Primary Outcome Measures
Name Time Method Overall Response Rate 2 months Proportion of subjects with complete response (CR/CMR) or partial response (PR/PMR)
- Secondary Outcome Measures
Name Time Method Disease Control Rate 2 months Proportion of subjects with stable disease or better (CR/CMR, PR/PMR or SD/NMR)
Duration of Overall Response 2 months Time to Response 2 months Progression Free Survival 2 months Overall Survival 2 months Safety - Assessment of Adverse Events 2 months
Trial Locations
- Locations (9)
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
UC Irvine Medical Center
🇺🇸Orange, California, United States
Tyler Hematology Oncology
🇺🇸Tyler, Texas, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
University of Pennsylvania, Abramson Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Duke University
🇺🇸Durham, North Carolina, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States