Richter's TransformationPhase 2NCT02378038
PNT2258 for Treatment of Patients With Richter's Transformation (Brighton)
A Phase 2 study testing PNT2258 in people with Richter's Transformation, run by Sierra Oncology LLC - a GSK company at 9 sites in United States.
Trial summary
This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Richter's Transformation
- What is being tested?
- PNT2258
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 9 sitesUnited States
- Study dates
- Aug 2015to Jun 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
- Histologically confirmed Richter's transformation (RT) from chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
- Availability of fresh or archived tumor tissue.
- FDG PET-CT (disease) positive baseline scan with measurable disease.
- ECOG performance status of 0-1.
- Evidence of disease progression at study entry.
- 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.
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- 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.
- Adequate bone marrow, renal, and hepatic function.
- Normal Coagulation profile.
- 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.
- Ability to participate in the clinical study for a minimum of at least 2 cycles (6 weeks).
Who cannot join
- Concurrent non-hematologic malignancies requiring treatment.
- No more than 2 prior regimens for DLBCL.
- Hodgkin's variant of Richter's lymphoma, accelerated CLL, composite lymphoma, interdigitating dendritic cell sarcoma, sarcoma, EBV-associated lymphoma or prolymphocytic transformation.
- Ongoing risk of bleeding.
- 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 subject or impair the assessment of the study results.
- Pregnancy or breast-feeding.
- Previous exposure to PNT2258.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Duke University
Durham, North Carolina, 27705
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Columbia University Medical Center
New York, New York, 10027
UC Irvine Medical Center
Orange, California, 92868
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Swedish Cancer Institute
Seattle, Washington, 98122
Tyler Hematology Oncology
Tyler, Texas, 75701
About this study
Official title: A Phase II Study of PNT2258 in Patients With Richter's Transformation (RT)
This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It 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.
- Conditions
- Richter's Transformation
- Being tested
- PNT2258
- Keywords
- PNT2258, Richter's Transformation, NHL, Non-Hodgkin's Lymphoma, Lymphoma, DLBCL, Diffuse Large B-cell Lymphoma, Lymphoma, Large B-cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, B-cell
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, B-Cell
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 will be administered at 120 mg/m2 on days 1-5 of a 21-day cycle for 8 induction cycles followed by continuation phase therapy at a dose of 100 mg/m2 on days 1-4 of a 28-day cycle. Receives: Drug: PNT2258 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Proportion of subjects with complete response (CR/CMR) or partial response (PR/PMR)
Measured: 2 months
Secondary outcomes (6)
Disease Control Rate
Proportion of subjects with stable disease or better (CR/CMR, PR/PMR or SD/NMR)
Measured: 2 months
Duration of Overall Response
Measured: 2 months
Time to Response
Measured: 2 months
Progression Free Survival
Measured: 2 months
Overall Survival
Measured: 2 months
Safety - Assessment of Adverse Events
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2016
- Study completionJun 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.
- Other trials for Richter's TransformationStudies 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
- 5 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, MD, Study chair, Sierra Oncology LLC - a GSK company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378038
- Sponsor's protocol ID
- PNT2258-04-Richter's
- Status last verified
- Jun 2023
- First submitted
- 26 Feb 2015
- Last updated
- 29 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of PNT2258 in Patients With Richter's Transformation (RT)
- ClinicalTrials.gov ID
- NCT02378038
- Acronym / sponsor ID
- PNT2258-04-Richter's
- Conditions
- Richter's Transformation
- Keywords
- PNT2258, Richter's Transformation, NHL, Non-Hodgkin's Lymphoma, Lymphoma, DLBCL, Diffuse Large B-cell Lymphoma, Lymphoma, Large B-cell, Diffuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sierra Oncology LLC - a GSK companyIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 Mar 2015 (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 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.
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 will be administered at 120 mg/m2 on days 1-5 of a 21-day cycle for 8 induction cycles followed by continuation phase therapy at a dose of 100 mg/m2 on days 1-4 of a 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed Richter's transformation (RT) from chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
- Availability of fresh or archived tumor tissue.
- FDG PET-CT (disease) positive baseline scan with measurable disease.
- ECOG performance status of 0-1.
- Evidence of disease progression at study entry.
Key exclusion criteria (8 listed)
- Concurrent non-hematologic malignancies requiring treatment.
- No more than 2 prior regimens for DLBCL.
- Hodgkin's variant of Richter's lymphoma, accelerated CLL, composite lymphoma, interdigitating dendritic cell sarcoma, sarcoma, EBV-associated lymphoma or prolymphocytic transformation.
- Ongoing risk of bleeding.
- CNS or leptomeningeal involvement of lymphoma
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: 2 months
Proportion of subjects with complete response (CR/CMR) or partial response (PR/PMR)
6 secondary outcomes
Disease Control Rate
Time frame: 2 months
Duration of Overall Response
Time frame: 2 months
Time to Response
Time frame: 2 months
Progression Free Survival
Time frame: 2 months
Overall Survival
Time frame: 2 months
Safety - Assessment of Adverse Events
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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, MD study chair
Sierra Oncology LLC - a GSK company
9 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 Richter's Transformation, run by Sierra Oncology LLC - a GSK company at 9 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 12 inclusion and 8 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: stopped early, 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 9 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: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.