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A Phase II Open Label Study of Brentuximab Vedotin in Combination with CHEP in Patients with Previously Untreated CD30-expressing Peripheral T-cell Lymphomas (PTCL)
EU CTIS ID: 2024-511567-28-01
What this study is testing
Primary Objective To assess efficacy (based on Lugano 2014 criteria) of brentuximab vedotin in combination with CHEP. Key Secondary Objective To assess safety and tolerability of brentuximab vedotin in combination with CHEP.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age >18 years 2. Written informed consent 3. Histologically confirmed diagnosis of CD30-expressing PTCL. The following histological subtypes according to the Revised European-American Lymphoma World Health Organization (WHO) 2016 classification are eligible: a. Systemic anaplastic large cell lymphoma (ALCL) ALK+ with age-adjusted international prognostic index (aaIPI) ≥1 b. Systemic anaplastic large cell lymphoma (ALCL) ALK- c. Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) d. Angioimmunoblastic T-cell lymphoma (AITL) e. Adult T-cell leukaemia/lymphoma (ATLL; acute and lymphoma types only, must be positive for human T cell leukaemia virus 1) f. Enteropathy-associated T-cell lymphoma (EATL) g. Hepatosplenic T-cell lymphoma h. Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITCL) i. Indolent T-cell lymphoproliferative disorder (T-LPD) of the gastrointestinal (GI) tract j. Follicular T-cell lymphoma k. Nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype 4. Positive CD30 expression by local pathology assessment. 5. Patients must have at least one measurable disease site. The lesion must be fluorodeoxyglucose (FDG)-avid by PET and must have a greatest transverse diameter of ≥1.5 cm and greatest perpendicular diameter of ≥1.0 cm by CT, as assessed by the site radiologist. 6. Eastern Cooperative Oncology Group (ECOG, Appendix B) performance status of 0 to 1 7. Patient must be autologous stem cell transplant (ASCT)-eligible 8. Patient must be appropriate candidate for treatment with anthracyclines 9. Patient must have the following laboratory criteria at screening: a. Absolute neutrophil count (ANC) ≥ 1.0 x 109/L (unless secondary to bone marrow involvement by PTCL) b. Platelet count ≥ 50 x 109/L (unless secondary to bone marrow involvement by PTCL) c. Total serum bilirubin < 1.5 × upper limit of normal (ULN) unless secondary to Gilbert’s syndrome or documented liver involvement by lymphoma. Patients with Gilbert’s syndrome or documented liver involvement by lymphoma may be included if their total bilirubin is ≤3 × ULN d. Alanine transaminase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤3 × ULN, or <5 × ULN in cases of documented liver involvement by lymphoma e. Serum creatinine clearance must be >50 mL/minute/1.73m2 either measured or calculated using a standard Cockcroft and Gault formula (Cockroft and Gault, 1976, Appendix A). 10. Females of childbearing potential (FCBP) must not be pregnant or breastfeeding and must agree to use two effective contraception methods (at least one highly-effective method and one additional acceptable (barrier) method, see Appendix G) each time engaging in sexual activity with a male during the study treatment and for 12 months following the last dose of treatment. FCBP must refrain from donating oocyte during the course of study or for 12 months following the last dose of treatment, whichever is longer. 11. Male participants must agree to use condom each time they have sex with a woman of childbearing potential during the study treatment and for 6 months following the last dose of treatment. In addition to the use of condom by male participants, their female partners who are of childbearing potential must use one highly effective contraception method (see Appendix G) at the same time. Male participants must refrain from donating sperm during the study participation or for 6 months following the last dose of treatment, whichever is longer. 12. In the opinion of investigator, the patient must: a. be able to understand, give written informed consent, and comply with all study-related procedures, medication use, and evaluations b. not have a history of noncompliance in relation to medical regimens or be considered potentially unreliable and/or uncooperative
You likely can't join if
- Patients must be excluded from participating in this clinical trial if they meet any of the following criteria: 1. Current diagnosis of any following lymphomas: a. Primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas. Cutaneous ALCL with extracutaneous tumour spread beyond locoregional lymph nodes is eligible (previous single-agent treatment to address cutaneous and locoregional disease is permissible) b. Mycosis fungoides (MF), including transformed MF c. PTCL CD30-negative 2. History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), such as carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer. 3. History of progressive multifocal leukoencephalopathy (PML). 4. Known central nervous system (CNS) lymphoma involvement 5. Prior treatment with brentuximab vedotin. 6. Baseline peripheral neuropathy ≥Grade 2 (per the NCI CTCAE, Version 5.0) 7. Left ventricular ejection fraction (LVEF) of < 45% or history of myocardial infarction ≤6 months, or symptomatic cardiac disease (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias) or prior treatment with anthracyclines. 8. Any uncontrolled Grade 3 or higher (per the National Cancer Institute’s Common Terminology Criteria for Adverse Events, NCI CTCAE Version 5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment. 9. Known human immunodeficiency virus (HIV) infection, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection. 10. History of hypersensitivity to any component of CHEP, to compounds of similar biological or chemical composition as brentuximab vedotin, and/or the excipients contained in any of the drug formulations of study treatment. 11. Females who are pregnant or breastfeeding 12. Planned CNS prophylaxis with intravenous high-dose methotrexate. 13. Vaccination with live vaccine within 30 days prior to study treatment 14. Any contraindication for brentuximab vedotin, cyclophosphamide, doxorubicin, etoposide or prednisone according to the respective SmPCs. 15. Severe hepatic or renal impairment.
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.