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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02378038
Recruitment Status : Terminated
First Posted : March 4, 2015
Last Update Posted : January 24, 2017
Information provided by (Responsible Party):
Sierra Oncology, Inc.

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.

Condition or disease Intervention/treatment Phase
Richter's Transformation Drug: PNT2258 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of PNT2258 in Patients With Richter's Transformation (RT)
Study Start Date : August 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: 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.
Drug: PNT2258

Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Disease control rate [ Time Frame: 6 months ]
  2. Duration of overall response [ Time Frame: 24 months ]
  3. Time to response [ Time Frame: 6 months ]
  4. Progression free survival [ Time Frame: 24 months ]
  5. Overall survival [ Time Frame: 24 months ]
  6. Safety [ Time Frame: 24 months ]
    Safety will be assessed by standard CTCAE criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02378038

United States, California
UC Irvine Medical Center
Orange, California, United States, 92868
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Columbia University Medical Center
New York, New York, United States, 10027
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
United States, Pennsylvania
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Tyler Hematology Oncology
Tyler, Texas, United States, 75701
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Sierra Oncology, Inc.
Study Chair: Barbara Klencke, MD Sierra Oncology, Inc.

Responsible Party: Sierra Oncology, Inc. Identifier: NCT02378038     History of Changes
Other Study ID Numbers: PNT2258-04-Richter's
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sierra Oncology, Inc.:
Richter's Transformation
Non-Hodgkin's Lymphoma
Diffuse Large B-cell Lymphoma
Lymphoma, Large B-cell, Diffuse
Lymphoma, Non-Hodgkin
Lymphoma, B-cell