Brighton: PNT2258 for Treatment of Patients with Richter's Transformatio

Phase 1

• Conditions: Diffuse large B-cell non-Hodgkin's lymphoma with Richter's Transformation (RT) from chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL); MedDRA version: 18.1Level: PTClassification code 10058728Term: Richter's syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001814-85-HU
• Lead Sponsor: ProNAi Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-05
• Last Update Posted: 27 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

1) Written informed consent
2) =18 years of age
3) Histologically confirmed diagnosis of diffuse large B-cell lymphoma in the setting of Richter's Transformation (RT) from chronic lymphocytic leukemia /small lymphocytic lymphoma (CLL/SLL)
4) Availability of fresh or archived tumor tissue
5) FDG PET-CT disease-positive baseline scan
6) ECOG performance status of 0-1
7) Evidence of disease progression at study entry
8) Discontinuation of prior anticancer therapy for =7 days and recovery to = CTCAE grade 2 (or baseline) from any acute or chronic toxicity associated with prior therapy
9) Previously received at least one prior regimen for CLL
10) Adequate organ function
11) Adequate bone marrow function
12) Normal coagulation profile
13) Ability to participate in the clinical study for at least 2 cycles (6 weeks)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 39

Exclusion Criteria

1) Concurrent non-hematologic malignancies requiring treatment
2) More than 1 prior regimen for DLBCL
3) Hodgkin's variant of Richter's lymphoma, accelerated CLL, composite lymphoma (i.e., discovery of CLL and another lymphoma at time of original diagnosis), interdigitating dendritic cell sarcoma, sarcoma, EBV-associated lymphoma or prolymphocytic transformation
4) Ongoing risk of bleeding due to active peptic ulcer disease or known bleeding diathesis or requirement for systemic therapeutic levels of anticoagulation with unfractionated heparin, low-molecular-weight heparin or heparin fractions or oral anticoagulants
5) Central nervous system (CNS) or leptomeningeal involvement of lymphoma
6) Concurrent clinically significant illness or medical condition that could adversely affect subject safety or the integrity of study results, as determined by the Investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified