PNT2258 for Treatment of Patients With r/r DLBCL (Wolverine)



Status:Active, not recruiting
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/13/2016
Start Date:December 2014
End Date:January 2017

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A Phase II Study of PNT2258 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

This study is a multi-center, nonrandomized, open label, phase II investigation of PNT2258
to characterize anti-tumor activity and collect safety data on patients with relapsed or
refractory (r/r) diffuse large B-cell lymphoma.


Inclusion Criteria:

Histologically confirmed diffuse large B-cell lymphoma that is refractory to prior therapy
or relapsed after prior therapy.

FDG PET-CT (disease) positive baseline scan with measurable disease.

The patient must have received prior therapy that included:

- CD20-targeted therapy (for example, rituximab),

- Alkylating agent (for example, cyclophosphomide), and

- Steroid, unless the patient is steroid intolerant

Exposure to at least 1 or 2 (but no more than 3) prior systemic cytotoxic chemotherapeutic
regimens.

Note: Only those subjects who are not eligible for high-dose chemotherapy and autologous
stem cell transplant (HD-ASCT), or who refuse HD-ASCT, are eligible with exposure to only
1 prior cytotoxic chemotherapeutic regimen.

ECOG performance status of 0-1.

The patient must be a stable baseline with CTCAE grade ≤ 2 regarding any acute or chronic
toxicity associated with prior therapy, and have discontinued prior anti-cancer therapy
for ≥ 14 days prior to C1D1; mitomycin-C for at least 6 weeks prior to C1D1; SCT ≥ 2
months prior to C1D1.

Note: Palliative steroids for control of disease-related symptoms are allowed and
maintenance hormone therapy is allowed.

Adequate organ function including:

- Hematologic: ANC ≥ 0.5 x 10^9/L. and platelets ≥ 50 x 10^9/L.

- Hepatic: Total Bilirubin ≤ 2 x ULN (patients with Gilbert's syndrome must have total
bilirubin ≤ 3 x ULN) and serum transaminase levels ≤ 2.5 x ULN. In the case of known
liver metastasis (i.e., radiological or biopsy documented), serum transaminase levels
must be ≤ 5 x ULN.

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

Willingness to: 1.) undergo pre-treatment biopsy to obtain adequate tissue for analysis
(e.g., core needle, excisional or incisional tumor biopsy) or 2.) provide archived tumor
(e.g., FFPE block) for analysis.

Exclusion Criteria:

Eligibility for high-dose chemotherapy (HDT) and stem cell transplant (SCT). Note:
Subjects who progressed ≥ 2 months after HDT/SCT are eligible

Concurrent malignancies requiring treatment.

Primary mediastinal (thymic) large B-cell lymphoma

Symptomatic CNS or leptomeningeal involvement of lymphoma.

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 patient or impair the assessment of the study
results.

Signs or symptoms of heart failure characterized as greater than NYHA Class II or other
significant cardiac abnormalities.

Pregnant or breast-feeding.

Prior exposure to PNT2258.

Life expectancy less than 3 months.
We found this trial at
27
sites
Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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Winter Haven, Florida 33880
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Winter Haven, FL
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1120 15th Street
Augusta, Georgia 30912
(706) 721-0211
Georgia Regents University Georgia Regents University, home of the Medical College of Georgia, is one...
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Boca Raton, Florida 33486
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Cumberland, Maryland 21502
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3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
720-754-4800
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Grand Rapids, Michigan 49503
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Greenville, South Carolina 29607
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Grosse pointe Woods, Michigan 48236
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Houston, Texas 77030
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Lafayette, Indiana
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Lafayette, Louisiana 70506
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409 West Circle Drive
Lansing, Michigan 48910
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Long Beach, California 90801
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Newport News, Virginia 23601
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Royal Oak, Michigan 48073
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San Juan, 00927
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Sioux Falls, South Dakota 57105
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Spokane, Washington 99208
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750 East Adams Street
Syracuse, New York 13210
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Tyler, Texas 75701
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