Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
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ClinicalTrials.gov Identifier: NCT01733238 |
Recruitment Status
:
Completed
First Posted
: November 26, 2012
Last Update Posted
: January 18, 2017
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Condition or disease | Intervention/treatment | Phase |
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Lymphoma, Non-Hodgkin's | Drug: PNT2258 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | PNT2258-02: A Pilot Phase II Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma |
Study Start Date : | November 2012 |
Actual Primary Completion Date : | August 2016 |
Actual Study Completion Date : | August 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: 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.
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Drug: PNT2258 |
- Anti-tumor activity [ Time Frame: 4.5 months ]Anti-tumor activity will be assessed by Computerized Tomography (CT) scan, FDG-Positron Emission Tomography (PET) scan and biomarker analysis.
- Safety [ Time Frame: 4.5 months ]Safety will be assessed by physical examination, clinical laboratory tests (i.e., hematology, chemistry, urinalysis) and electrocardiogram.
- Pharmacokinetic Profile of PNT2258 [ Time Frame: 2 weeks ]The pharmacokinetic profile will be assessed by blood collection during Cycle 1.
- Pharmacodynamic Effect of PNT2258 [ Time Frame: 4 weeks ]The pharmacodynamic effect of PNT2258 will be assessed by blood collection during Cycles 1 and 2.

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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:
- Written informed consent must be obtained from the patient.
- Participants must be ≥18 years of age.
- Morphologically confirmed diagnosis of non-Hodgkin's lymphoma (NHL).
- At least a single measureable tumor mass (long axis > 1.5 cm).
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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".
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Disease that has relapsed after administration of primary therapy that included:
- Rituximab and
- 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.
- 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.
- No previous exposure to PNT2258.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- 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.
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Adequate organ function including:
- Hematologic Function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L prior to treatment. Platelets ≥ 100 x 109/L.
- Hepatic: Total Bilirubin ≤ 1.5 x ULN and serum transaminase levels ≤ 2.5 x upper limits of normal (ULN).
- 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:
- Candidates for HDT and autologous SCT. Note: Patients who progressed > 3 months after high-dose therapy (HDT)/SCT are eligible.
- Concurrent malignancies requiring treatment.
- Symptomatic central nervous system (CNS) or leptomeningeal involvement of lymphoma.
- Concurrent serious medical conditions (as determined by the Principal Investigator) including, but not limited to, HIV-associated lymphoma; active bacterial, fungal or viral infections.
- Signs and symptoms of heart failure characterized as greater than New York Heart Association (NYHA) Class I.
- 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.
- Women who are pregnant or breast-feeding.

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 ClinicalTrials.gov identifier (NCT number): NCT01733238
United States, Indiana | |
Horizon Oncology Research, Inc. | |
Lafayette, Indiana, United States, 47905 | |
United States, Michigan | |
Cancer and Hematology Centers of Western Michigan, P.C. | |
Grand Rapids, Michigan, United States, 49503 | |
St. John Hospital and Medical Center, Van Elslander Cancer Center | |
Grosse Pointe Woods, Michigan, United States, 48236 |
Study Chair: | Barbara Klencke, M.D. | Sierra Oncology, Inc. | |
Principal Investigator: | Ayad Al-Katib, MD | St. John Hospital and Medical Center, Van Elslander Cancer Center |
Responsible Party: | Sierra Oncology, Inc. |
ClinicalTrials.gov Identifier: | NCT01733238 History of Changes |
Other Study ID Numbers: |
PNT2258-02 |
First Posted: | November 26, 2012 Key Record Dates |
Last Update Posted: | January 18, 2017 |
Last Verified: | January 2017 |
Keywords provided by Sierra Oncology, Inc.:
PNT2258 Lymphoma Non-Hodgkin's Lymphoma NHL |
Additional relevant MeSH terms:
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |