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Lymphoma, Diffuse Large B-CellPhase 2NCT02226965

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

A Phase 2 study testing PNT2258 in people with Lymphoma, Diffuse Large B-Cell, run by Sierra Oncology LLC - a GSK company at 27 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Diffuse Large B-Cell
What is being tested?
PNT2258
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
27 sitesin 2 countries
Study dates
Dec 2014to 22 Aug 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • Pregnant or breast-feeding.
  • Prior exposure to PNT2258.
  • Life expectancy less than 3 months.

Trial locations and contacts

27 sites in 2 countries.

27 sites in 2 countries

United States26 sites

  • Georgia Regents University

    Augusta, Georgia, 30912

  • Lynn Cancer Institute

    Boca Raton, Florida, 33486

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Western Maryland Health System

    Cumberland, Maryland, 21502

  • Baylor Research Institute

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Colorado Blood and Cancer Institute

    Denver, Colorado, 80218

  • Duke University

    Durham, North Carolina, 27710

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Bon Secours Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • Horizon Oncology Research, Inc.

    Lafayette, Indiana, 47905

  • UHC Oncology

    Lafayette, Louisiana, 70506

  • Michigan State University

    Lansing, Michigan, 48910

  • Long Beach Memorial Medical Center

    Long Beach, California, 90806

  • University of Southern California

    Los Angeles, California, 90033

  • Peninsula Cancer Institute

    Newport News, Virginia, 23601

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Avera Research Institute

    Sioux Falls, South Dakota, 57108

  • Medical Oncology Associates, PS

    Spokane, Washington, 99208

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Tyler Hematology Oncology

    Tyler, Texas, 75701

  • Bond Clinic, P.A.

    Winter Haven, Florida, 33880

Other trials in United States

Puerto Rico1 site

  • Fundacion de Investigacion

    San Juan, 00927

Other trials in Puerto Rico

About this study

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

This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It 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.

Being tested
PNT2258
Keywords
PNT2258, DLBCL, Diffuse Large B-cell Lymphoma, NHL, Non-Hodgkin's Lymphoma, Lymphoma
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PNT2258Drug

    Also called DNAi, BCL2 targeted therapy

Study groups in NCT02226965
Study groupRoleWhat they receive
PNT2258ExperimentalPNT2258 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.
Receives: Drug: PNT2258

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    The proportion of patients with complete response (CR/complete metabolic response [CMR]) or partial response (PR/partial metabolic response [PMR]) according to the revised 2014 International Working Group (IWG) criteria for lymphoma (Cheson 2014)

    Measured: 19 months

Secondary outcomes (6)

  1. Disease Control Rate

    The proportion of patients who have a response of stable disease (SD/no metabolic response [NMR]) or better by investigator assessment

    Measured: 19 months

  2. Time to Response

    The number of months from Cycle 1 Day 1 until the date of the first documented response

    Measured: 19 months

  3. Progression-free Survival

    The number of months from C1D1 until the date of DLBCL progression or death from any cause, or to the last date at which progression status was adequately assessed for censored observation

    Measured: 19 months

  4. Safety - Assessment of Adverse Events

    Characterization of the type, frequency, severity, timing of onset, duration, and relationship to study drug of any treatment-emergent adverse events, laboratory abnormalities, serious adverse events or adverse events leading to discontinuation of study treatment

    Measured: 36 months

  5. Overall Survival

    The number of months from C1D1 until the date of death from any cause, or to the last date at which survival status was adequately assessed for censored observations

    Measured: 19 months

  6. Duration of Overall Response

    The time from the initial CMR or PMR until the date of progression or death from any cause, or to the last date at which progression status was adequately assessed for censored observations

    Measured: 19 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2014 (estimated)
  2. Study startDec 2014
  3. Primary completion11 Jul 2016
  4. Study completion22 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02226965
Sponsor's protocol ID
PNT2258-03-DLBCL
Status last verified
Jun 2023
First submitted
26 Aug 2014
Last updated
29 Jun 2023
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PNT2258 in people with Lymphoma, Diffuse Large B-Cell, run by Sierra Oncology LLC - a GSK company at 27 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: 19 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02226965.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.

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