Overview

This trial is active, not recruiting.

Condition lymphoma, diffuse large b-cell
Treatment pnt2258
Phase phase 2
Sponsor ProNAi Therapeutics, Inc
Start date December 2014
End date January 2017
Trial size 61 participants
Trial identifier NCT02226965, PNT2258-03-DLBCL

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
PNT2258 will be administered at 120 mg/m2 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 8 "induction" cycles of therapy. Subjects with CR/CMR, PR/PMR or SD/NMR at the end-of-cycle 8 scan then receive ongoing PNT2258 therapy at a dose of 100 mg/m2 on days 1-4 of a 28 day cycle until progressive disease, the occurrence of unacceptable toxicity, non-compliance, voluntary withdrawal or if in the opinion of the investigator the subject is no longer benefiting from exposure to PNT2258.
pnt2258 DNAi, BCL2 targeted therapy

Primary Outcomes

Measure
Overall response rate
time frame: 6 months

Secondary Outcomes

Measure
Disease control rate
time frame: 6 months
Time to response
time frame: 12 months
Progression-free survival
time frame: 24 months
Safety
time frame: 24 months
Overall survival
time frame: 24 months
Duration of overall response
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Phase II Study of PNT2258 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by ProNAi Therapeutics, Inc.
Location data was received from the National Cancer Institute and was last updated in July 2016.