Efficacy and Safety of Brentuximab Vedotin Combined With Lisaftoclax in CD30+ Cutaneous T-cell Ly… (NCT07717580) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy and Safety of Brentuximab Vedotin Combined With Lisaftoclax in CD30+ Cutaneous T-cell Lymphoma (CTCL)
China46 participantsStarted 2026-07-31
Plain-language summary
This is a prospective, single-center, open-label, randomized, controlled phase II clinical trial. The main purpose of this study is to evaluate the efficacy and safety of combining brentuximab vedotin (an anti-CD30 antibody-drug conjugate, ADC) with lisaftoclax (APG-2575, a novel B-cell lymphoma 2 (BCL-2) inhibitor) in patients with CD30-positive cutaneous T-cell lymphoma (CTCL), specifically including mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL).
Previous studies suggest that the overexpression of the anti-apoptotic protein BCL-2 may contribute to brentuximab vedotin resistance in CTCL. Researchers hypothesize that adding a highly selective BCL-2 inhibitor (lisaftoclax) can reverse this drug resistance, enhance tumor cell apoptosis, and improve clinical outcomes.
In this study, approximately 46 eligible patients will be randomly assigned in a 1:1 ratio to one of two treatment arms:
Monotherapy arm (control): Patients will receive brentuximab vedotin intravenously at a dose of 1.8 mg/kg every 3 weeks for a total of 16 cycles.
Combination arm (experimental): Patients will receive the same brentuximab vedotin regimen. Additionally, starting from the 6th cycle, patients will receive oral lisaftoclax. To mitigate the risk of tumor lysis syndrome (TLS), a daily dose ramp-up will be implemented in the first cycle of lisaftoclax. Subsequently, lisaftoclax will be administered at a targeted dose of 600 mg daily on days 1 to 10 of each 21-day cycle, for a total of 9 combination cycles.
The primary endpoint of the study is the objective response rate (ORR) evaluated at the end of the 16 cycles. Secondary endpoints include the improvement of skin lesions (evaluated by modified severity-weighted assessment tool (mSWAT) score), pruritus relief (visual analog scale (VAS) score), and the incidence of adverse events (AEs). Independent, blinded assessors will be utilized to evaluate the clinical responses to reduce bias.
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
. Age greater than or equal to 18 years.
. Confirmed diagnosis of mycosis fungoides (MF) or primary cutaneous anaplastic large cell lymphoma (pcALCL).
. CD30 positive confirmed by skin biopsy (at least 2 lesion biopsies for MF patients, and at least 1 lesion biopsy for pcALCL patients). CD30 positivity is defined as greater than or equal to 10% of target lymphocytes showing CD30 membrane, cytoplasmic, and/or Golgi-like staining, with a staining intensity higher than the background staining of the corresponding negative control.
. Prior treatment requirements:
. Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to 2.
. Adequate hepatic, renal, and hematopoietic function.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Objective Response Rate (ORR)
Timeframe: At the end of 16 treatment cycles (up to approximately 48 weeks)
. Females of childbearing potential must be willing to use highly effective methods of contraception during the study and for 6 months after the last dose of study drug; or must be postmenopausal for greater than or equal to 1 year, or surgically sterile.
. Males, even if surgically sterilized (i.e., post-vasectomy), must agree to use highly effective methods of contraception during the study and for 6 months after the last dose of study drug.
Exclusion criteria
. Concomitant diagnosis of systemic anaplastic large cell lymphoma (sALCL), other non-Hodgkin lymphomas (except lymphomatoid papulosis), Sézary syndrome, or stage B2 disease.
. Active central nervous system (CNS) involvement of lymphoma.
. Prior treatment with chemotherapy, allogeneic or autologous stem cell transplantation.
. Prior treatment with brentuximab vedotin or any B-cell lymphoma 2 (BCL-2) inhibitors.
. Receipt of corticosteroids for cutaneous T-cell lymphoma (CTCL) or skin-directed therapies within 3 weeks prior to the first dose of study drug.
. Receipt of antibody-directed therapy, immunoglobulin therapy, or other monoclonal antibodies within 12 weeks prior to the first dose of study drug.
. History of other primary malignancies not in complete remission for greater than or equal to 3 years (exceptions: adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer, squamous intraepithelial lesions, or localized prostate cancer with no evidence of recurrence based on prostate-specific antigen (PSA) levels).
. Presence of severe organ dysfunction or history of major organ diseases, including: