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PNT2258-02: A Pilot Phase II Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma

Phase 2
18 Years
Open (Enrolling)
Lymphoma, Non-Hodgkin's

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Trial Information

PNT2258-02: A Pilot Phase II Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma

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.

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Anti-tumor activity

Outcome Description:

Anti-tumor activity will be assessed by Computerized Tomography (CT) scan, FDG-Positron Emission Tomography (PET) scan and biomarker analysis.

Outcome Time Frame:

4.5 months

Safety Issue:


Principal Investigator

Ayad M. Al-Katib, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. John Hospital and Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

November 2012

Completion Date:

October 2014

Related Keywords:

  • Lymphoma, Non-Hodgkin's
  • PNT2258
  • Lymphoma
  • Non-Hodgkin's Lymphoma
  • NHL
  • Lymphoma
  • Lymphoma, Non-Hodgkin



Horizon Oncology Research, Inc.Lafayette, Indiana  
Cancer and Hematology Centers of Western Michigan, P.C.Grand Rapids, Michigan  49503
St. John Hospital and Medical Center, Van Elslander Cancer CenterGrosse Pointe Woods, Michigan  48236