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New treatment option for Peripheral T-cell Lymphoma
Official title Sintilimab Combined With Chidamide in Treating Peripheral T Cell Lymphoma
ClinicalTrials.gov ID: NCT04512534
What this study is testing
What is PD-1 antibody+ HDAC inhibitor?
PD-1 antibody+ HDAC inhibitor is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for peripheral t-cell lymphoma.
Also referred to as Sintilimab, Chidamide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-center, single-arm, phase 2 study to evaluate the efficacy and safety of Anti-PD-1 antibody(Sintilimab) plus HDAC inhibitor(Chidamide) in patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age range from 18 to 75 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Pathologically confirmed relapsed/refractory Peripheral T-cell lymphoma (Including PTCL-NOS, AITL, anaplastic large cell lymphoma（ALTL）, excluding...
- At least one two-dimensional measurable lesion with a length diameter of at least 1.5cm and vertical diameter of at least 1.0cm (measured by CT or...
- Adequate medullary hematopoiesis function ( WBC≥3.5×109/L, ANC≥1.5×109/L, PLT≥80×109/L, HB≥90g/L. If the peripheral blood indicators demonstrate...
You likely can't join if
- Patients allergic of any drug in this regimen;
- Previous treatment with anti-PD-1 antibody combined with HDAC inhibitor (Patients only received single agent of treatment regime or sequentially...
- Patients with clinically significant heart disease, including severe cardiac insufficiency: New York Heart Disease Association (NYHA) grade IV...
- Patients who have received grade II or above surgery within 3 weeks before enrollment;
- History of other malignancy within the past 5 years (except for 1. basal cell carcinoma of the skin and 2. carcinoma in situ of the cervix and 3...
- Patients who had received other antitumor therapy (including corticosteroid therapy, immunotherapy) or participated in other clinical studies within...
See the full eligibility criteria
- Age range from 18 to 75 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Pathologically confirmed relapsed/refractory Peripheral T-cell lymphoma (Including PTCL-NOS, AITL, anaplastic large cell lymphoma（ALTL）, excluding Nature Killer（NK）/T cell lymphoma);
- At least one two-dimensional measurable lesion with a length diameter of at least 1.5cm and vertical diameter of at least 1.0cm (measured by CT or MRI);
- Adequate medullary hematopoiesis function ( WBC≥3.5×109/L, ANC≥1.5×109/L, PLT≥80×109/L, HB≥90g/L. If the peripheral blood indicators demonstrate abnormal due to bone marrow or spleen invasion by lymphoma, Enrollment...
- Adequate hepatic function (total serum bilirubin, ALT and AST≤1.5 times of upper limit of normal);
- Adequate renal function (serum creatinine≤1.5 times the upper limit of normal, creatinine clearence≥50ml/min);
- Echocardiography or radionuclide cardia functional test, LVEF≥50%;
- Patients of child-bearing period agree to use appropriate contraception. The serum pregnancy test of women in childbearing period was negative within 2 weeks before enrollment.
- Willingness to provide pathological tissue specimens (20 pieces of wax or paraffin tissue sections);
- Expectation survival time over 3 months;
- Willingness to provide written informed consent.
- Patients allergic of any drug in this regimen;
- Previous treatment with anti-PD-1 antibody combined with HDAC inhibitor (Patients only received single agent of treatment regime or sequentially received anti-PD-1 and HDAC inhibitor are allowed to enroll);
- Patients with clinically significant heart disease, including severe cardiac insufficiency: New York Heart Disease Association (NYHA) grade IV cardiac insufficiency, unstable angina. And myocardial infarction...
- Patients who have received grade II or above surgery within 3 weeks before enrollment;
- History of other malignancy within the past 5 years (except for 1. basal cell carcinoma of the skin and 2. carcinoma in situ of the cervix and 3. patients who had received treatment for the purpose of cure and had not...
- Patients who had received other antitumor therapy (including corticosteroid therapy, immunotherapy) or participated in other clinical studies within 4 weeks before the start of the enrollment (if patients received...
- Patients with significant coagulation abnormality;
- Patients with autoimmune diseases requiring treatment or with a history of syndrome requiring systemic use of steroid immunosuppressive agents, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis...
- Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interfere with results interpretation, including uncontrolled diabetes, or pulmonary disease (a history of interstitial pneumonia...
- Evidence of central nervous system disease;
- Patients who received the live vaccine within 4 weeks of the start of the enrollment;
- Patients with hepatitis B (HBV HBsAg positive and HBV-DNA≥105), hepatitis C (HCV) infection (HCV antibody positive and HCV-RNA detectable); And people with other acquired or congenital immune deficiency diseases...
- Pregnant or lactating women;
- Patients who have had previous organ transplants (except autologous hematopoietic stem cell transplants);
- Severe or uncontrolled infections;
- Patients with history of severe neurological or psychiatric illness, including dementia or epilepsy;
- Patients with drug abuse, medical, psychological or social conditions that may interfere with the study results or the assessment of the study results;
- Patients are unsuitable for the enrollment according to investigator's judgement.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.