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

Learn more about:
Related Clinical Trial
Safety & Efficacy Study of Epcoritamab in Subjects With R/R Chronic Lymphocytic Leukemia and Richter’s Syndrome ALX148, Rituximab and Lenalidomide for the Treatment of Indolent and Aggressive B-cell Non-Hodgkin Lymphoma R-EPOCH in Combination With Ibrutinib for Patients With Classical RT of CLL Phase 1 Study VIP152 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Richter Syndrome A Study to Evaluate the Efficacy and Safety of Obinutuzumab, Ibrutinib, and Venetoclax in Patients With Richter’s Syndrome; Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia Study of Oral Administration of LP-118 in Patients With Relapsed or Refractory NHL, RT, MM, T-PLL, Acute Leukemia (AML, ALL), MDS, MDS/MPN, and MF Ipilimumab, Ibrutinib, and Nivolumab for the Treatment of Chronic Lymphocytic Leukemia and Richter Transformation Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter’s Transformation Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma Venetoclax in Combination With Ublituximab and Umbralisib (TGR-1202) in Patients With Relapsed or Refractory CLL/SLL Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia Allogeneic Stem Cell Transplant for CLL Study of a Triple Combination Therapy, DTRM-555, in Patients With R/R CLL or R/R Non-Hodgkin’s Lymphomas Atezolizumab, Gemcitabine, Oxaliplatin, and Rituximab in Treating Patients With Relapsed or Refractory Transformed Diffuse Large B-Cell Lymphoma Atezolizumab, Obinutuzumab, and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Relapsed or Refractory Richter Syndrome Duvelisib and Nivolumab in Treating Patients With Richter Syndrome or Transformed Follicular Lymphoma Sotrastaurin Acetate in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia, Prolymphocytic Leukemia, or Richter’s Transformation Registry of the German CLL Study Group Nivolumab and Ibrutinib in Treating Patients With Relapsed, Refractory, or High-Risk Untreated Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Richter Transformation ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (Btk) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia A Study of Acalabrutinib and Vistusertib in Subjects With Relapsed/Refractory B-cell Malignancies Study of Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) With Ofatumumab in Patients With Richter’s Syndrome PNT2258 for Treatment of Patients With Richter’s Transformation (Brighton) Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter’s Transformation Efficacy and Safety of Zanubrutinib Plus Tislelizumab for Treatment of Patients With Richter Transformation BLINAtumomab After R-CHOP Debulking Therapy for Patients With Richter Transformation Oxaliplatin, Fludarabine, Cytarabine, and Rituximab in Patients With Richter’s Transformation and Leukemias Obinutuzumab Containing Conditioning Regimen for Patients With Poor Risk CLL or Richter`s Transformation Requiring Allogeneic Stem Cell Transplantation Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma or Relapsed or Refractory Richter Syndrome (MK-3475-170/KEYNOTE-170) Duvelisib and Venetoclax in Relapsed or Refractory CLL or SLL or RS Study of Blinatumomab in Richter Transformation Genomic and Proteomic Study of Richter Syndrome (CGPSR) CRC043: A Phase II Study of Venetoclax in Combination With Dose-adjusted EPOCH-R for Patients With Richter’s Syndrome Study of Ibrutinib & Obinutuzumab With/Without CHOP for Richter’s Transformation or Richter’s Syndrome Patients Obinutuzumab, High Dose Methylprednisolone (HDMP), and Lenalidomide for the Treatment of Patients With Richter’s Syndrome A Trial of CHOP-R Therapy, With or Without Acalabrutinib, in Patients With Newly Diagnosed Richter’s Syndrome Selinexor in Initial or Refractory and/or Relapsed Richter’s Transformation

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
      Transformation.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Overall Response Rate

Secondary Outcome

 Disease Control Rate

Condition

Richter's Transformation

Intervention

PNT2258

Study Arms / Comparison Groups

 PNT2258
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.

Publications

* 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

Drug

Estimated Enrollment

5

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
             children.

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

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Barbara Klencke, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02378038

Organization ID

PNT2258-04-Richter's


Responsible Party

Sponsor

Study Sponsor

Sierra Oncology, Inc.


Study Sponsor

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


Verification Date

January 2017