PNT2258 for Treatment of Patients With Richter's Transformation (Brighton)
Status: | Terminated |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 7/2/2016 |
Start Date: | August 2015 |
End Date: | June 2016 |
A Phase II Study of PNT2258 in Patients With Richter's Transformation (RT)
This study is a multi-center, single-arm, 2-stage, open-label phase II investigation of
PNT2258 to characterize anti-tumor activity and collect safety data on patients with
Richter's Transformation.
PNT2258 to characterize anti-tumor activity and collect safety data on patients with
Richter's Transformation.
Inclusion Criteria:
1. Histologically confirmed Richter's transformation (RT) from chronic lymphocytic
leukemia/small lymphocytic lymphoma (CLL/SLL).
2. Availability of fresh or archived tumor tissue.
3. FDG PET-CT (disease) positive baseline scan with measurable disease.
4. ECOG performance status of 0-1.
5. Evidence of disease progression at study entry.
6. Discontinuation of prior anticancer therapy for ≥ 7 days prior to C1D1 and recovered
to ≤ CTCAE grade 2 (or baseline) from any acute or chronic toxicity associated with
prior therapy.
7. Must have previously received at least one prior chemotherapeutic regimen for RT.
- Previously untreated RT patients deemed ineligible for, or that refuse, intensive
chemotherapy are eligible.
8. Adequate bone marrow, renal, and hepatic function.
9. Normal Coagulation profile.
10. Agreement to use acceptable methods of contraception during the study and for ≥ 120
days after the last dose of PNT2258 if sexually active and able to bear or beget
children.
11. Ability to participate in the clinical study for a minimum of at least 2 cycles (6
weeks).
Exclusion Criteria:
1. Concurrent non-hematologic malignancies requiring treatment.
2. No more than 2 prior regimens for DLBCL.
3. Hodgkin's variant of Richter's lymphoma, accelerated CLL, composite lymphoma,
interdigitating dendritic cell sarcoma, sarcoma, EBV-associated lymphoma or
prolymphocytic transformation.
4. Ongoing risk of bleeding.
5. CNS or leptomeningeal involvement of lymphoma
6. 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 subject or impair the
assessment of the study results.
7. Pregnancy or breast-feeding.
8. Previous exposure to PNT2258.
We found this trial at
9
sites
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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303 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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