BridgeMD
New treatment option for Relapsed/Refractory PTCLT With at Least One Line of Prior Systemic...
Official title SHR2554 Clinical Study of Chidamide in the Treatment of T-cell Lymphoma
ClinicalTrials.gov ID: NCT06122389
What this study is testing
What is SHR2554; Chidamide analog tablets?
SHR2554; Chidamide analog tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for relapsed/refractory ptclt with at least one line of prior systemic therapy.
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 study was designed to compare the efficacy and safety of SHR2554 with Chidamide in patients with relapsed/refractory PTCL.
- Phase 3: a large, late-stage study
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 70
You may be able to join if
- Age 18-70 years old (including 18 and 70 years old), gender is not limited;
- Histologically confirmed T-cell lymphoma;
- ECOG physical status must be 0 or 1;
- Life expectancy ≥12 weeks;
- For relapsed refractory patients who have received ≥ first-line treatment, at least one prior treatment is adequate;
You likely can't join if
- Have been treated with compounds with the same mechanism;
- Accompanied by central nervous system infiltration;
- Received autologous stem cell transplantation within 60 days before signing the agreement, and received allogeneic stem cell transplantation within...
- Major surgery or severe trauma occurred 4 weeks before the first dose of study drug administration;
- Received anti-tumor treatment within 4 weeks before the first dose of the study drug, and received Chinese medicine treatment with anti-tumor effect...
- Active phase of HBV or HCV infection;
See the full eligibility criteria
- Age 18-70 years old (including 18 and 70 years old), gender is not limited;
- Histologically confirmed T-cell lymphoma;
- ECOG physical status must be 0 or 1;
- Life expectancy ≥12 weeks;
- For relapsed refractory patients who have received ≥ first-line treatment, at least one prior treatment is adequate;
- Have not received histone deacetylase inhibitors;
- Have measurable lesions;
- Bone marrow function is basically normal;
- Liver and kidney function is basically normal;
- Blood coagulation function is basically normal;
- Female people with a possibility of becoming pregnant must undergo a blood pregnancy test prior to the first dose, with a negative result, and be willing to use a highly effective method of contraception for 90 days...
- The subject has recovered from the toxic effects of the last treatment before the first dosing;
- The subject personally signs and dates the informed consent to show that the subject has been fully informed of all the circumstances related to the clinical trial;
- people are willing and able to comply with visit schedules, dosing schedules, laboratory examinations, and other clinical trial procedures.
- Have been treated with compounds with the same mechanism;
- Accompanied by central nervous system infiltration;
- Received autologous stem cell transplantation within 60 days before signing the agreement, and received allogeneic stem cell transplantation within 90 days;
- Major surgery or severe trauma occurred 4 weeks before the first dose of study drug administration;
- Received anti-tumor treatment within 4 weeks before the first dose of the study drug, and received Chinese medicine treatment with anti-tumor effect within 2 weeks before the first dose of the study drug; Receiving...
- Active phase of HBV or HCV infection;
- A history of immunodeficiency, including HIV seropositive, or other acquired or congenital immunodeficiency diseases;
- Active infection or unexplained fever \> 38.5°C within 2 weeks of initial dosing;
- A history of clinically severe cardiovascular disease;
- Abnormal electrocardiogram (ECG) examination;
- Cerebrovascular accident or transient ischemic attack occurred within 6 months before entering the study;
- Have other malignancies within 5 years prior to screening, other than adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, ductal carcinoma...
- The subject has another serious/severe acute or chronic illness or mental illness, including recent (within the past year) or current suicidal ideation or behavior, or laboratory abnormalities that may increase the...
- The people are the staff of the research center directly related to this clinical trial or their family members, or the subordinates of this trial although not directly related to this trial, or the staff employed by...
- Pregnant and lactating women;
- The subject is unable to swallow, or has a history of active gastrointestinal inflammation, chronic diarrhea, known diverticulosis, or a history of gastrectomy or gastric banding that affects drug absorption;
- The subject is taking a known medium or strong CYP inducer;
- In the judgment of the investigator, objective conditions (including the subject's psychological state, family relationship, social factors or geographical factors) make the subject unable to complete the planned study...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing 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.