PTCL Patients Who Achieved Complete Response From Frontline TreatmentPhase 2/3NCT05822050
An Open, Single Center, Non-randomized, Single Arm Clinical Study of Evaluating the Efficacy of Selinexor in the Maintenance Treatment of PTCL
A Phase 2/3 study testing Selinexor in people with PTCL Patients Who Achieved Complete Response From Frontline Treatment, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Selinexor maintenance therapy in PTCL patients who achieved complete response from frontline treatment, and to analyze the relationship between gene mutation in PTCL and disease prognosis and clinical features by using Next-generation sequencing (NGS) detection. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- PTCL Patients Who Achieved Complete Response From Frontline Treatment
- What is being tested?
- Selinexor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 30 Jun 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients fully understand the study, voluntarily participate and sign the informed consent (ICF);
- Age range from 18 to 85 years old (including upper and lower limits);
- ECOG (Eastern Cooperative Oncology Group) score 0 ~ 2;
- PTCL confirmed by histopathology falls into one of the following subtypes according to the WHO classification standard revised in 2016:1) Peripheral T-cell lymphoma non-specific type (PTCL-NOS) 2) vascular immunoblastic T-cell lymphoma (AITL) 3) ALK+ systemic anaplastic large T-cell lymphoma (ALK+ALCL) 4) Alk-systemic anaplastic large T-cell lymphoma (ALK-AlCl) 5) extranasal NK/ T-cell lymphoma (NK/TCL)6) Other subtypes of PTCL that the researchers considered suitable for inclusion.
- Subjects achieved complete remission by radiographic assessment at mid-stage.
- Subjects must provide a written pathological/histological diagnosis report during the screening period and must agree to provide tumor tissue sections or tumor/lymph node tissue samples for central laboratory testing.
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- Expected survival is at least 12 weeks.
- Patients must meet the following requirements for laboratory tests at screening time and have not received cell growth factor, platelet, or granulocyte infusion within 7 days prior to screening hematological evaluation.1) Neutrophil absolute value ≥1.5×109/L in subjects without bone marrow involvement and ≥1.0×109/L in subjects with bone marrow involvement;2) Hemoglobin ≥90g/L in subjects without bone marrow involvement (in the absence of red blood cell infusion within 14 days), hemoglobin ≥75g/L in subjects with bone marrow involvement;3) Platelets ≥75×109/L in subjects without bone marrow involvement and ≥50×109/L in subjects with bone marrow involvement;4) Serum total bilirubin ≤1.5× upper limit of normal (ULN) (total bilirubin ≤3×ULN if elevated bilirubin level is caused by lymphoma invading the liver);5) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN;If elevated AST and ALT are caused by lymphoma invading liver, both AST and ALT should be ≤5×ULN).6) Creatinine <1.5×ULN.
- Eligible patients (male and female) who are fertile must agree to use a reliable contraceptive method (hormonal or barrier method or abstinence) with their partner during the trial period and for at least 7 months after the last medication;Female patients of reproductive age must have had a negative blood pregnancy test within 14 days prior to inclusion.
Who cannot join
- Patients with leukemic PTCL (such as adult T-cell leukemia/lymphoma, etc.), or lymphoma leukemia stage (bone marrow examination lymphoma cell proportion ≥20%), or central nervous system (CNS) involvement, or complicated hemophagocytic syndrome.
- Allergic history to similar drugs and excipients of the study drug.
- Participated in other clinical studies and used the study drug within 4 weeks prior to the first administration of the study drug.
- The toxic reactions of previous antitumor therapy have not recovered, and there are still more than grade 1 toxic reactions, except hair loss and pigmentation.
- Impaired heart function or significant heart disease, including but not limited to: 1) myocardial infarction, congestive heart failure, viral myocarditis in the 6 months prior to screening;Heart disease with symptoms that require therapeutic intervention, such as unstable angina, arrhythmia, etc.;2) Cardiac function grade Ⅱ to Ⅳ (New York College of Cardiology Cardiac Function Grade NYHA);3) Echocardiographic examination of cardiac ejection fraction (EF) below 50% or below the lower limit of laboratory test value;
- Active hepatitis B (surface antigen positive with HBV-DNA titers higher than 2000IU/ml) or hepatitis C (HCV antibody positive with HCV ribonucleic acid (HCV RNA) titers higher than the upper limit of the study center's normal).
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- History of severe autoimmune diseases and immunodeficiency, including positive human immunodeficiency virus (HIV) antibodies;Or other acquired or congenital immunodeficiency diseases;Or have a history of organ transplantation.
- History of other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).
- Major surgery was performed within 6 weeks prior to screening or was expected to be performed during the study period.
- There are significant gastrointestinal disorders at the time of screening that may affect drug intake, transport or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.).
- Uncontrolled hypertension (refers to patients with type 2 diabetes whose blood pressure still reaches the level 3 hypertension standard after antihypertensive treatment, with systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg) or who cannot be controlled by oral hypoglycemic drugs and insulin therapy.
- History of active bleeding within 3 months prior to screening.
- History of mental illness or psychotropic substance abuse or dependence.
- Pregnant or lactating women.
- Other conditions considered inappropriate for participation in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021
Xingtong Wang, PHD
About this study
Official title: An Open, Single Center, Non-randomized, Single Arm Clinical Study of Evaluating the Efficacy of Selinexor in the Maintenance Treatment of Peripheral T-cell Lymphomas (PTCL)
To evaluate the efficacy and safety of Selinexor maintenance therapy in PTCL patients who achieved complete response from frontline treatment, and to analyze the relationship between gene mutation in PTCL and disease prognosis and clinical features by using Next-generation sequencing (NGS) detection.
- Being tested
- Selinexor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelinexorDrug
XPO1 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Low risk group | Experimental | 10 patients. Selinexor 60mg QW Oral 21days/cycle Receives: Drug: Selinexor |
| Medium/High risk group | Experimental | 10 patients. Selinexor 60mg QW Oral with Chemotherapy 21days/cycle Receives: Drug: Selinexor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival rate of 1 year (1y PFS rate)
progression-free survival rate, defined as the proportion of patients who have not experience PFS events after one year from the date of start of selinexor treatment. PFS events is defined as the first documentation of relapse or progressive disease, death due to any cause, or receipt of subsequent systemic chemotherapy to treat residual or progressive peripheral T-cell lymphoma as determined by the investigator, whichever came first.
Measured: 1 year from the start of selinexor treatment
Secondary outcomes (1)
Progression Free Survival (PFS)
progression-free survival, defined as the time from the date of start of selinexor treatment to the date of first documentation of relapse or progressive disease, death due to any cause, or receipt of subsequent systemic chemotherapy to treat residual or progressive peripheral T-cell lymphoma as determined by the investigator, whichever came first.
Measured: from the date of start of selinexor to the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start1 Jun 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTCL Patients Who Achieved Complete Response From Frontline TreatmentStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ou Bai, MD/PHD, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822050
- Sponsor's protocol ID
- PTCL-001
- Status last verified
- Aug 2023
- First submitted
- 30 Mar 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single Center, Non-randomized, Single Arm Clinical Study of Evaluating the Efficacy of Selinexor in the Maintenance Treatment of Peripheral T-cell Lymphomas (PTCL)
- ClinicalTrials.gov ID
- NCT05822050
- Acronym / sponsor ID
- PTCL-001
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of Selinexor maintenance therapy in PTCL patients who achieved complete response from frontline treatment, and to analyze the relationship between gene mutation in PTCL and disease prognosis and clinical features by using Next-generation sequencing (NGS) detection.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low risk group | Experimental | Drug: Selinexor10 patients. Selinexor 60mg QW Oral 21days/cycle |
| Medium/High risk group | Experimental | Drug: Selinexor10 patients. Selinexor 60mg QW Oral with Chemotherapy 21days/cycle |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients fully understand the study, voluntarily participate and sign the informed consent (ICF);
- Age range from 18 to 85 years old (including upper and lower limits);
- ECOG (Eastern Cooperative Oncology Group) score 0 ~ 2;
- PTCL confirmed by histopathology falls into one of the following subtypes according to the WHO classification standard revised in 2016:1) Peripheral T-cell lymphoma non-specific type (PTCL-NOS) 2) vascular immunoblastic T-cell lymphoma (AITL) 3) ALK+ systemic anaplastic large T-cell lymphoma (ALK+ALCL) 4) Alk-systemic anaplastic large T-cell lymphoma (ALK-AlCl) 5) extranasal NK/ T-cell lymphoma (NK/TCL)6) Other subtypes of PTCL that the researchers considered suitable for inclusion.
- Subjects achieved complete remission by radiographic assessment at mid-stage.
Key exclusion criteria (15 listed)
- Patients with leukemic PTCL (such as adult T-cell leukemia/lymphoma, etc.), or lymphoma leukemia stage (bone marrow examination lymphoma cell proportion ≥20%), or central nervous system (CNS) involvement, or complicated hemophagocytic syndrome.
- Allergic history to similar drugs and excipients of the study drug.
- Participated in other clinical studies and used the study drug within 4 weeks prior to the first administration of the study drug.
- The toxic reactions of previous antitumor therapy have not recovered, and there are still more than grade 1 toxic reactions, except hair loss and pigmentation.
- Impaired heart function or significant heart disease, including but not limited to: 1) myocardial infarction, congestive heart failure, viral myocarditis in the 6 months prior to screening;Heart disease with symptoms that require therapeutic intervention, such as unstable angina, arrhythmia, etc.;2) Cardiac function grade Ⅱ to Ⅳ (New York College of Cardiology Cardiac Function Grade NYHA);3) Echocardiographic examination of cardiac ejection fraction (EF) below 50% or below the lower limit of laboratory test value;
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 |
|---|---|---|
| SelinexorXPO1 inhibitor | Drug | Low risk group, Medium/High risk group |
Primary outcome
Progression Free Survival rate of 1 year (1y PFS rate)
Time frame: 1 year from the start of selinexor treatment
progression-free survival rate, defined as the proportion of patients who have not experience PFS events after one year from the date of start of selinexor treatment. PFS events is defined as the first documentation of relapse or progressive disease, death due to any cause, or receipt of subsequent systemic chemotherapy to treat residual or progressive peripheral T-cell lymphoma as determined by the investigator, whichever came first.
1 secondary outcome
Progression Free Survival (PFS)
Time frame: from the date of start of selinexor to the end of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Selinexor in people with PTCL Patients Who Achieved Complete Response From Frontline Treatment, run by The First Hospital of Jilin University at 1 site in China.
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 9 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xingtong wang, doctor (13596459561, hitony-tt-123@123.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival rate of 1 year (1y PFS rate) (time frame: 1 year from the start of selinexor treatment). 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 3 Aug 2023.