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New treatment option for Peripheral T-cell Lymphoma
Official title Bendamustine Combined With Chidamide and Lenalidomide for Relapsed and Refractory PTCL Patients
ClinicalTrials.gov ID: NCT07072221
What this study is testing
What is BCL regimen?
BCL regimen is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for 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 bendamustine combined with chidamide and lenalidomide in R/R PTCL patients.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years, 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 peripheral T-cell lymphoma (PTCL) confirmed by histopathology/cytology using the 2022 World Health Organization (WHO) Classification of...
You likely can't join if
- Patients with R/R disease previously used chidamide, lenalidomide and bendamustine, 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 ≥18 years, 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 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, lenalidomide and bendamustine;
- 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, lenalidomide and bendamustine, 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 and older. 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.