Lymphoma, Non-Hodgkin'sPhase 2NCT01733238
Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase 2 study testing PNT2258 in people with Lymphoma, Non-Hodgkin's, run by Sierra Oncology LLC - a GSK company at 3 sites in United States.
Trial summary
This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It study is a multi-center, nonrandomized, open-label, pilot Phase II investigation of PNT2258 to characterize anti-tumor activity and collect safety data on patients with relapsed or refractory lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin's
- What is being tested?
- PNT2258
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2012to Aug 2016
- 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
- Written informed consent must be obtained from the patient.
- Participants must be ≥18 years of age.
- Morphologically confirmed diagnosis of non-Hodgkin's lymphoma (NHL).
- At least a single measureable tumor mass (long axis > 1.5 cm).
- An FDG-PET positive baseline scan.
- A positive scan is defined per revised Cheson criteria as "focal or diffuse FDG uptake above background in a location incompatible with normal anatomy or physiology, without a specific standardized uptake value cutoff".
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- Disease that has relapsed after administration of primary therapy that included:
- Rituximab and
- CHOP, EPOCH, bendamustine or similar chemotherapy or subsequent salvage regimen.
- Note: Relapse is defined as progression after a complete response to therapy or radiographic evidence of active disease after a partial response or stable disease.
- Have received three or fewer complete courses of systemic cytotoxic regimens. Note: Rituximab (alone or in combination with cytotoxic chemotherapy) is not considered a cytotoxic regimen.
- No previous exposure to PNT2258.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Have discontinued all prior anti-cancer therapies for at least 21 days; biologic therapy for at least 4 half-lives of the drug(s); radio-immunotherapy (10 weeks); autologous stem cell transplantation (SCT) (3 months) and must be at a stable baseline regarding any acute toxicity associated with prior therapy.
- Adequate organ function including:
- Hematologic Function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L prior to treatment. Platelets ≥ 100 x 109/L.
- Hepatic: Total Bilirubin ≤ 1.5 x ULN and serum transaminase levels ≤ 2.5 x upper limits of normal (ULN).
- Renal: Serum creatinine ≤2 x ULN or creatinine clearance ≥ 60 mL/min/1.73 m2 for subjects with serum creatinine levels above 2x ULN.
Who cannot join
- Candidates for HDT and autologous SCT. Note: Patients who progressed > 3 months after high-dose therapy (HDT)/SCT are eligible.
- Concurrent malignancies requiring treatment.
- Symptomatic central nervous system (CNS) or leptomeningeal involvement of lymphoma.
- Concurrent serious medical conditions (as determined by the Principal Investigator) including, but not limited to, HIV-associated lymphoma; active bacterial, fungal or viral infections.
- Signs and symptoms of heart failure characterized as greater than New York Heart Association (NYHA) Class I.
- History of myocardial infarct or prolonged corrected QT (QTc) interval (>450 milliseconds (msecs) for males or >470 msecs for females) or other significant cardiac abnormalities.
- Women who are pregnant or breast-feeding.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cancer and Hematology Centers of Western Michigan, P.C.
Grand Rapids, Michigan, 49503
St. John Hospital and Medical Center, Van Elslander Cancer Center
Grosse Pointe Woods, Michigan, 48236
Horizon Oncology Research, Inc.
Lafayette, Indiana, 47905
About this study
Official title: PNT2258-02: A Pilot Phase II Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It study is a multi-center, nonrandomized, open-label, pilot Phase II investigation of PNT2258 to characterize anti-tumor activity and collect safety data on patients with relapsed or refractory lymphoma.
Read the detailed description
PNT2258 will be administered at a dose of 120 mg/m2, as a 3-hour intravenous (IV) infusion 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 6 cycles of therapy.
- Conditions
- Lymphoma, Non-Hodgkin's
- Being tested
- PNT2258
- Keywords
- PNT2258, Lymphoma, Non-Hodgkin's Lymphoma, NHL
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNT2258Drug
| Study group | Role | What they receive |
|---|---|---|
| PNT2258 | Experimental | PNT2258 120 mg/m2 will be administered as a 2-hour intravenous infusion 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 6 cycles of therapy. Receives: Drug: PNT2258 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Subjects who had a best response of complete response or partial response as assessed by the investigator
Measured: 39 months
Secondary outcomes (1)
Progression-free Survival
The time from Cycle 1 Day 1 until the date of lymphoma progression or death from any cause, or to the last date at which progression status was adequately assessed for censored observation
Measured: 39 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Non-Hodgkin'sStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sierra Oncology LLC - a GSK company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Klencke, M.D., Study chair, Sierra Oncology LLC - a GSK companyAyad Al-Katib, MD, Principal investigator, St. John Hospital and Medical Center, Van Elslander Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733238
- Sponsor's protocol ID
- PNT2258-02
- Status last verified
- Jun 2023
- First submitted
- 20 Nov 2012
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Harb W, Lakhani NJ, Messmann R, Klencke B, Al-Katib AM. A Phase 2 Study of PNT2258 for Treatment of Relapsed or Refractory B-Cell Malignancies. Clin Lymphoma Myeloma Leuk. 2021 Dec;21(12):823-830. doi: 10.1016/j.clml.2021.07.016. Epub 2021 Jul 23.
PubMed 34417162
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PNT2258-02: A Pilot Phase II Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT01733238
- Acronym / sponsor ID
- PNT2258-02
- Conditions
- Lymphoma, Non-Hodgkin's
- Keywords
- PNT2258, Lymphoma, Non-Hodgkin's Lymphoma, NHL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Sierra Oncology LLC - a GSK companyIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 26 Nov 2012 (estimated)
- Results
- Posted 10 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It study is a multi-center, nonrandomized, open-label, pilot Phase II investigation of PNT2258 to characterize anti-tumor activity and collect safety data on patients with relapsed or refractory lymphoma.
Detailed description
PNT2258 will be administered at a dose of 120 mg/m2, as a 3-hour intravenous (IV) infusion 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 6 cycles of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PNT2258 | Experimental | Drug: PNT2258PNT2258 120 mg/m2 will be administered as a 2-hour intravenous infusion 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 6 cycles of therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Written informed consent must be obtained from the patient.
- Participants must be ≥18 years of age.
- Morphologically confirmed diagnosis of non-Hodgkin's lymphoma (NHL).
- At least a single measureable tumor mass (long axis > 1.5 cm).
- An FDG-PET positive baseline scan.
Key exclusion criteria (7 listed)
- Candidates for HDT and autologous SCT. Note: Patients who progressed > 3 months after high-dose therapy (HDT)/SCT are eligible.
- Concurrent malignancies requiring treatment.
- Symptomatic central nervous system (CNS) or leptomeningeal involvement of lymphoma.
- Concurrent serious medical conditions (as determined by the Principal Investigator) including, but not limited to, HIV-associated lymphoma; active bacterial, fungal or viral infections.
- Signs and symptoms of heart failure characterized as greater than New York Heart Association (NYHA) Class I.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PNT2258 | Drug | PNT2258 |
Primary outcome
Overall Response Rate
Time frame: 39 months
Subjects who had a best response of complete response or partial response as assessed by the investigator
1 secondary outcome
Progression-free Survival
Time frame: 39 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34417162Harb W, Lakhani NJ, Messmann R, Klencke B, Al-Katib AM. A Phase 2 Study of PNT2258 for Treatment of Relapsed or Refractory B-Cell Malignancies. Clin Lymphoma Myeloma Leuk. 2021 Dec;21(12):823-830. doi: 10.1016/j.clml.2021.07.016. Epub 2021 Jul 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Klencke, M.D. study chair
Sierra Oncology LLC - a GSK company
Ayad Al-Katib, MD principal investigator
St. John Hospital and Medical Center, Van Elslander Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PNT2258 in people with Lymphoma, Non-Hodgkin's, run by Sierra Oncology LLC - a GSK company at 3 sites in United States.
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 18 inclusion and 7 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 22 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 3 sites in United States. 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 10 Mar 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: 39 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 NCT01733238, which also lists 1 linked publication.
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 22 Jun 2023.