A Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorub… (NCT05673785) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in Chinese Participants With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL)
China52 participantsStarted 2023-02-10
Plain-language summary
This study will use a combination of Brentuximab vedotin with CHP to treat adult Chinese participants with CD30+ PTCL.
The main aims of the study are to evaluate:
* Side effect from the A+CHP
* Check how much A+CHP stays in their blood over time. This will help Takeda to work out the best dose to give people in the future.
* If A+CHP improves outcome of newly diagnosed CD30+ PTCL
Brentuximab vedotin will be given through vein on Day 1 of each 21-day cycle. Cyclophosphamide and doxorubicin will be given through vein. Prednisone will be given orally daily on Days 1 through 5.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants must have newly diagnosed CD30+ PTCL, per the Revised European American Lymphoma 2016 World Health Organization (WHO) classification, by local assessment. Tumor specimen must be submitted before enrollment for subsequent central pathology review to confirm histology (and anaplastic lymphoma kinase (ALK) status, if applicable), and CD30 expression. Eligible histologies include:
. ALK-positive systemic anaplastic large cell lymphoma (sALCL) with an International Prognostic Index (IPI) score of ≥2.
. ALK-negative sALCL.
. PTCL- not otherwise specified (NOS).
. Angioimmunoblastic T-cell lymphoma (AITL).
. Enteropathy associated T-cell lymphoma (EATL).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for CD30-positive peripheral T-cell lymphoma in Chinese participants — can you confirm whether my diagnosis and CD30 status would have made me eligible for a study like this, and what that means for my treatment options now?
2The trial is in Phase 2, which means researchers are still building evidence on how well this works and how safe it is — how does that level of uncertainty compare to what we already know about standard treatments for my type of lymphoma?
3The study is combining brentuximab vedotin with cyclophosphamide, doxorubicin, and prednisone — are any of these drugs already part of what you're considering for my treatment, and what are the key risks I should understand about this combination?
4Since the trial is actively measuring treatment-related side effects, abnormal lab results, and blood pressure changes as primary outcomes, what does that tell us about the safety profile doctors are still trying to establish for this regimen?
5The trial is no longer recruiting, so I can't enroll — but based on what this study is testing, are there similar approved treatments or other open trials using brentuximab vedotin for CD30-positive T-cell lymphoma that might be worth exploring for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Response Rate (ORR) by Independent Review Facility (IRF) Assessment Per Revised Response Criteria for Malignant Lymphoma
Timeframe: Up to approximately 7 months
2
Percentage of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE)
Timeframe: Up to approximately 7 months
3
Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements
Timeframe: Up to approximately 7 months
4
Number of Participants With Abnormal Changes From Baseline in Vital Sign Measurements (Blood Pressure)
. Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2.
Exclusion criteria
. Systemic anticancer therapy, including traditional Chinese medicine with antitumor indication for disease under study before the first dose of study drugs.
. Major surgery within 28 days before the first dose of study drug.
. Known human immunodeficiency virus (HIV)-positive status.
. Known hepatitis B virus (HBV) surface antigen (HBsAg) seropositivity or active hepatitis C virus infection.
. Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
. Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug:
. Left-ventricular ejection fraction \<45%.
. Myocardial infarction within 6 months of enrollment.