Comparing Soquelitinib with Belinostat for not otherwise specified peripheral t-cell lymphoma
Official title: Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma
A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of ITK Inhibitor Soquelitinib Versus Physician's Choice Standard of Care Treatment (Selected Single Agent) in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma
Interventions
Soquelitinib
Soquelitinib 200 mg tablets will be taken by mouth two times a day
Belinostat
Belinostat (1000 mg/m2) will be administered by intravenous infusion once daily on Days 1 through 5 of each 21-day cycle
Pralatrexate
Pralatrexate (30 mg/m2) will be administered intravenously over 3 to 5 minutes once weekly for 6 weeks in each 7-week cycle
Canadian Sites (3)
BC Cancer Research Institute
Vancouver, British Columbia, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
The Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Eligibility Criteria
See who this study is looking for40 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- +Adult participants ≥18 years of age on the day of signing the informed consent formInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymphoid Neoplasms.
- +Progressed on, be refractory to, relapsed, or intolerant to standard therapy for their cancer. At least 1 but not more than 3 prior systemic therapies.
- +Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm by computed tomography, as assessed by the siteTrial siteA hospital or clinic where a study is actually run.Read more → radiologist.
- +Life expectancy \>12 weeks.
- +Adequate organ function as determined by:
- +Absolute neutrophil count ≥ 1.0×10\^9/L (1000/mm3) (without receiving granulocyte-colony stimulating factor)
- +Platelet count ≥ 100×10\^9/L (without transfusion)
- +Hemoglobin ≥ 9.0 g/dL, without packed red blood cell transfusion within the last 1 week of starting study drug
- +Prothrombin time international normalized ratio and partial thromboplastin time ≤1.5 × upper limit of normal (ULN), unless participant is receiving anticoagulant therapy and prothrombin time or activated partial thromboplastin time is within therapeutic range of intended use of anticoagulants
- +Calculated creatinine clearance (CrCl) according to Cockcroft-Gault formula and based on ideal body weight or 24-hour urine CrCl ≥ 50 mL/minute
- +Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 × ULN. For participants with Gilbert's disease: ≤ 3.0 mg/dL or discussion with the Medical Monitor
- +Aspartate aminotransferase and alanine transaminase ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases)
- +Serum albumin \> 2.5 g/dL
- +Serum calcium \< 12 mg/dL or corrected serum calcium \< ULN
- +Must have recovered from all AEs due to previous therapies to Grade ≤ 1 or baselineBaselineYour starting measurements, taken before treatment begins.Read more → except for the following:
- +Grade ≤ 2 neuropathy
- +Alopecia and non-acute toxicities
- +Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least 1 highly effective method of contraception from the time of screeningScreeningThe checks done before joining, to see whether a study fits.Read more → and must agree to continue using such precautions for 120 days after the last dose of study drug for participants who receive soquelitinib, or 6 months after the last dose for participants who receive either belinostat or pralatrexate.
- +Non-sterilized males who are sexually active with a female partner of childbearing potential must use a condom plus spermicide from Day 1 through 120 days after the last dose of study drug.
- +If major received major surgery, then must have recovered adequately per the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → from the toxicity and/or complications from the intervention prior to starting study treatment
Exclusion
- −Known to be positive for HIV, or positive test for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen \[HBsAg\]) or positive test for hepatitis C antibody.
- −Participants who have T-cell lymphoma with active central nervous system involvement.
- −Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
- −History of primary immunodeficiency or sold organ transplantation.
- −History of opportunistic infection within 30days of screeningScreeningThe checks done before joining, to see whether a study fits.Read more → requiring active systemic treatment or active infection requiring IV therapy.
- −Any active infection requiring IV therapy.
- −History of invasive prior malignancy that required systemic therapy within last 3 years.
- −Any condition that confounds the ability to interpret data from the study.
- −Prior administration of an ITK inhibitor.
- −Participants who need immediate cytoreductive therapy.
- −Participants requiring the concomitant use of strong inhibitors or inducers of CYP3A or who have received these within 5 half-lives or 14 days prior to the start of study treatment.
- −History of allogeneic hematopoietic stem cell transplantation.
- −Candidate for hematopoietic stem cell transplantation at screening.
- −History of progressive disease within 6 months of autologous hematopoietic stem cell transplantation.
- −Concurrent enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → in another clinical study
- −Participants who cannot ingest medications orally or who have malabsorption.
- −Females who are pregnant, lactating, or intend to become pregnant during their participation in the study, starting with the screening visit through 6 months after the last dose of study treatment.
- −Monoclonal antibody therapy for cancer, radiotherapy, or chemotherapy within 3 weeks and targeted therapy within 2 weeks prior to the first dose of study treatment.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Soquelitinib, Belinostat, Pralatrexate.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 150 people.
The study is currently expected to finish around December 2028.
The main measurement is taken over: Up to 4 years post study treatment initiation.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Progression-free survival — measured over Up to 4 years post study treatment initiation.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06561048 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About SoquelitinibDrug
Soquelitinib 200 mg tablets will be taken by mouth two times a day
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About BelinostatDrug
Belinostat (1000 mg/m2) will be administered by intravenous infusion once daily on Days 1 through 5 of each 21-day cycle
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PralatrexateDrug
Pralatrexate (30 mg/m2) will be administered intravenously over 3 to 5 minutes once weekly for 6 weeks in each 7-week cycle
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 4 years post study treatment initiation.
The study as a whole is currently expected to finish around 2028-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 150 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 6 locations, including: Vancouver, British Columbia, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada; Ann Arbor, Michigan, United States; New York, New York, United States; Seattle, Washington, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
A Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib versus physician's choice standard of care (SOC) treatment (selected single agents) in participants with relapsed/refractory (R/R) peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), follicular helper T-cell lymphomas (FHTCLs), or systemic anaplastic large-cell lymphoma (sALCL).
Other Sites (5)
Roger Cancer Center University of Michigan Health
Ann Arbor, Michigan, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
University of Washington Fred Hutch Cancer Center
Seattle, Washington, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.