Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
This study is currently recruiting participants.
Verified January 2014 by Pronai Therapeutics, Inc
Information provided by (Responsible Party):
Pronai Therapeutics, Inc
First received: November 20, 2012
Last updated: January 24, 2014
Last verified: January 2014
This 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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||PNT2258-02: A Pilot Phase II Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
Primary Outcome Measures:
Secondary Outcome Measures:
- Safety [ Time Frame: 4.5 months ] [ Designated as safety issue: No ]
Safety will be assessed by physical examination, clinical laboratory tests (i.e., hematology, chemistry, urinalysis) and electrocardiogram.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
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.
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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).
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".
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.
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733238
|Horizon Oncology Research, Inc.
|Lafayette, Indiana, United States, 47905 |
|Principal Investigator: Wael A. Harb, M.D. |
|Cancer and Hematology Centers of Western Michigan, P.C.
|Grand Rapids, Michigan, United States, 49503 |
|Principal Investigator: Nehal Lakhani, M.D. |
|St. John Hospital and Medical Center, Van Elslander Cancer Center
|Grosse Pointe Woods, Michigan, United States, 48236 |
|Principal Investigator: Ayad M. Al-Katib, M.D. |
Pronai Therapeutics, Inc
||Ayad M. Al-Katib, M.D.
||St. John Hospital and Medical Center
No publications provided
||Pronai Therapeutics, Inc
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 20, 2012
||January 24, 2014
||United States: Food and Drug Administration
Keywords provided by Pronai Therapeutics, Inc:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Neoplasms by Histologic Type
Immune System Diseases