Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma

NCT ID: NCT01733238

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2016-08-31

Brief Summary

This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It study is a multi-center, nonrandomized, open-label, pilot Phase II investigation of PNT2258 to characterize anti-tumor activity and collect safety data on patients with relapsed or refractory lymphoma.

Detailed Description

PNT2258 will be administered at a dose of 120 mg/m2, as a 3-hour intravenous (IV) infusion on days 1-5 of a 21-day cycle. Treatment may continue (unless there is disease progression or the occurrence of unacceptable toxicity) for a total of 6 cycles of therapy.

Conditions

Lymphoma, Non-Hodgkin's

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PNT2258

PNT2258 120 mg/m2 will be administered as a 2-hour intravenous infusion on days 1-5 of a 21-day cycle. Treatment may continue (unless there is disease progression or the occurrence of unacceptable toxicity) for a total of 6 cycles of therapy.

Group Type: EXPERIMENTAL

PNT2258

Intervention Type: DRUG

Interventions

PNT2258

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Written informed consent must be obtained from the patient.

2. Participants must be ≥18 years of age.

3. Morphologically confirmed diagnosis of non-Hodgkin's lymphoma (NHL).

4. At least a single measureable tumor mass (long axis > 1.5 cm).

5. An FDG-PET positive baseline scan.

a. A positive scan is defined per revised Cheson criteria as "focal or diffuse FDG uptake above background in a location incompatible with normal anatomy or physiology, without a specific standardized uptake value cutoff".

6. Disease that has relapsed after administration of primary therapy that included:

1. Rituximab and

2. CHOP, EPOCH, bendamustine or similar chemotherapy or subsequent salvage regimen.

Note: Relapse is defined as progression after a complete response to therapy or radiographic evidence of active disease after a partial response or stable disease.

7. Have received three or fewer complete courses of systemic cytotoxic regimens. Note: Rituximab (alone or in combination with cytotoxic chemotherapy) is not considered a cytotoxic regimen.

8. No previous exposure to PNT2258.

9. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

10. Have discontinued all prior anti-cancer therapies for at least 21 days; biologic therapy for at least 4 half-lives of the drug(s); radio-immunotherapy (10 weeks); autologous stem cell transplantation (SCT) (3 months) and must be at a stable baseline regarding any acute toxicity associated with prior therapy.

11. Adequate organ function including:

1. Hematologic Function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L prior to treatment. Platelets ≥ 100 x 109/L.

2. Hepatic: Total Bilirubin ≤ 1.5 x ULN and serum transaminase levels ≤ 2.5 x upper limits of normal (ULN).

3. Renal: Serum creatinine ≤2 x ULN or creatinine clearance ≥ 60 mL/min/1.73 m2 for subjects with serum creatinine levels above 2x ULN.

Exclusion Criteria

1. Candidates for HDT and autologous SCT. Note: Patients who progressed > 3 months after high-dose therapy (HDT)/SCT are eligible.

2. Concurrent malignancies requiring treatment.

3. Symptomatic central nervous system (CNS) or leptomeningeal involvement of lymphoma.

4. Concurrent serious medical conditions (as determined by the Principal Investigator) including, but not limited to, HIV-associated lymphoma; active bacterial, fungal or viral infections.

5. Signs and symptoms of heart failure characterized as greater than New York Heart Association (NYHA) Class I.

6. History of myocardial infarct or prolonged corrected QT (QTc) interval (>450 milliseconds (msecs) for males or >470 msecs for females) or other significant cardiac abnormalities.

7. Women who are pregnant or breast-feeding.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sierra Oncology LLC - a GSK company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara Klencke, M.D.

Role: STUDY_CHAIR

Sierra Oncology LLC - a GSK company

Ayad Al-Katib, MD

Role: PRINCIPAL_INVESTIGATOR

St. John Hospital and Medical Center, Van Elslander Cancer Center

Locations

Horizon Oncology Research, Inc.

Lafayette, Indiana, United States

Cancer and Hematology Centers of Western Michigan, P.C.

Grand Rapids, Michigan, United States

St. John Hospital and Medical Center, Van Elslander Cancer Center

Grosse Pointe Woods, Michigan, United States

Countries

United States

References

Harb W, Lakhani NJ, Messmann R, Klencke B, Al-Katib AM. A Phase 2 Study of PNT2258 for Treatment of Relapsed or Refractory B-Cell Malignancies. Clin Lymphoma Myeloma Leuk. 2021 Dec;21(12):823-830. doi: 10.1016/j.clml.2021.07.016. Epub 2021 Jul 23.

Reference Type: DERIVED

PMID: 34417162 (View on PubMed)

Other Identifiers

PNT2258-02

Identifier Type: -

Identifier Source: org_study_id