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

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Brief Title

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

Official Title

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

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

Study Phase

Phase 2

Study Type


Primary Outcome

Overall Response Rate

Secondary Outcome

 Disease Control Rate


Richter's Transformation



Study Arms / Comparison Groups

Description:  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.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

August 2015

Completion Date

June 2016

Primary Completion Date

June 2016

Eligibility Criteria

        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.

         10. 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

         11. Ability to participate in the clinical study for a minimum of at least 2 cycles (6

        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.




18 Years - N/A

Accepts Healthy Volunteers



Barbara Klencke, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Sierra Oncology, Inc.

Study Sponsor

Barbara Klencke, MD, Study Chair, Sierra Oncology, Inc.

Verification Date

January 2017