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

Richter's Transformation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02378038
• Other study ID #: PNT2258-04-Richter's
• Status: Terminated
• Phase: Phase 2
• Start date: August 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2023
• Source: Sierra Oncology LLC - a GSK company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Richter's Transformation

Intervention

Drug:
• PNT2258

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Duke University	Durham	North Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Columbia University Medical Center	New York	New York
United States	UC Irvine Medical Center	Orange	California
United States	University of Pennsylvania, Abramson Cancer Center	Philadelphia	Pennsylvania
United States	Swedish Cancer Institute	Seattle	Washington
United States	Tyler Hematology Oncology	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sierra Oncology LLC - a GSK company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate	Proportion of subjects with complete response (CR/CMR) or partial response (PR/PMR)	2 months
Secondary	Disease Control Rate	Proportion of subjects with stable disease or better (CR/CMR, PR/PMR or SD/NMR)	2 months
Secondary	Duration of Overall Response		2 months
Secondary	Time to Response		2 months
Secondary	Progression Free Survival		2 months
Secondary	Overall Survival		2 months
Secondary	Safety - Assessment of Adverse Events		2 months