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New treatment option for CD30+ Peripheral T-cell Lymphoma
Official title Chidamide Combined With Brentuximab Vedotin Regimen for CD30+ PTCL Patients
ClinicalTrials.gov ID: NCT07074457
What this study is testing
What is Induction therapy-3 cycles of BvC (Brentuximab vedotin plus Chidamide)?
Induction therapy-3 cycles of BvC (Brentuximab vedotin plus Chidamide) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cd30+ peripheral t-cell lymphoma.
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
- To evaluate the efficacy and safety of chidamide combined with brentuximab vedotin regimen for CD30 positive PTCL patients who are unfit for chemotherapy.
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 ≥70 years or age \< 70 years and unfit for chemotherapy, male or female not limited;
- Patients must have the capacity to understand and willingly provide written informed consent;
- ECOG score 0-3 points;
- Expected lifespan\>3 months;
- Patients with CD30+ peripheral T-cell lymphoma (PTCL) confirmed by histopathology/cytology using the 2022 World Health Organization (WHO)...
You likely can't join if
- Patients with R/R disease previously used chidamide and brentuximab vedotin or received any other anti-tumor therapy within 4 weeks.
- Patients enrolled in another clinical study within 4 weeks;
- HIV infection and/or active hepatitis B or C;
- Uncontrolled active infections;
- Severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine\>3 times the upper limit of normal);
- Existence of organic heart disease or severe arrhythmia, leading to clinical symptoms or abnormal heart function (NYHA functional class ≥ 2);
See the full eligibility criteria
- Age ≥70 years or age \< 70 years and unfit for chemotherapy, male or female not limited;
- Patients must have the capacity to understand and willingly provide written informed consent;
- ECOG score 0-3 points;
- Expected lifespan\>3 months;
- Patients with CD30+ peripheral T-cell lymphoma (PTCL) confirmed by histopathology/cytology using the 2022 World Health Organization (WHO) Classification of Diseases;
- Measurable lesions with a short diameter of ≥15mm defined by PET/CT.
- R/R PTCL: patients with at least previous first-line treatment failure and no prior exposure to chidamide and brentuximab vedotin.
- Patients are unfit for chemotherapy after evaluation or are not considered for chemotherapy for other reasons;
- Any non-hematological toxicity, except hair loss, associated with prior treatment in patients with R/R disease, as per NCI CTCAE version 5.0, must be managed and resolved to at least grade 1;
- Appropriate organ function: Cardiac function: ejection fraction ≥ 50%, asymptomatic arrhythmia; Liver function: alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal, total...
- Adequate bone marrow reserve is defined as: Hemoglobin ≥ 9g/dL, Platelet count ≥ 70 × 10 \^ 9/L, The absolute value of neutrophils is ≥ 1.0 × 10 \^ 9/L, If accompanied by bone marrow invasion, platelet count ≥ 50 × 10...
- people with fertility or potential for fertility must be willing to undergo contraception from the date of registration in this study until the study follow-up period;
- Patients with good compliance.
- Patients with R/R disease previously used chidamide and brentuximab vedotin or received any other anti-tumor therapy within 4 weeks.
- Patients enrolled in another clinical study within 4 weeks;
- HIV infection and/or active hepatitis B or C;
- Uncontrolled active infections;
- Severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine\>3 times the upper limit of normal);
- Existence of organic heart disease or severe arrhythmia, leading to clinical symptoms or abnormal heart function (NYHA functional class ≥ 2);
- Simultaneously present other tumors that require treatment or intervention;
- Previous or current history of vascular embolism;
- Pregnant or lactating women;
- In a state of severe immune suppression;
- Other psychological conditions that hinder patients from participating in research or signing informed consent forms.
- Patients are unlikely to complete all protocol study visits and procedures or do not meet the requirements for study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, 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 Suzhou, Jiangsu, 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.