Cutaneous T-Cell Lymphoma/Mycosis FungoidesPhase 2BV-LISA-CTCLNCT07717580
Efficacy and Safety of Brentuximab Vedotin Combined With Lisaftoclax in CD30+ Cutaneous T-cell Lymphoma (CTCL)
A Phase 2 study testing Brentuximab Vedotin (Bv) and Lisaftoclax (APG-2575) in people with Cutaneous T-Cell Lymphoma/Mycosis Fungoides and Primary Cutaneous Anaplastic Large Cell Lymphoma, run by Peking University First Hospital at 1 site in China.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T-Cell Lymphoma/Mycosis Fungoides, Primary Cutaneous Anaplastic Large Cell Lymphoma
- What is being tested?
- Brentuximab Vedotin (Bv) and Lisaftoclax (APG-2575)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2026to 30 Dec 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- pcALCL: Must have received ≥ 1 prior systemic therapy or radiotherapy.
- MF: Must have received ≥ 1 prior systemic therapy.
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- Note: Patients must be chemotherapy-naïve.
- Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to 2.
- Adequate hepatic, renal, and hematopoietic function.
- 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.
- No cognitive or communication barriers; capable of understanding and willing to sign a written informed consent form (ICF), and willing to comply with the study visits and procedures.
- Good venous access for required blood sampling.
Who cannot join
- 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.
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- 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:
- Cardiac: Left ventricular ejection fraction (LVEF) less than 50%; unstable angina; acute myocardial infarction within the past 6 months; New York Heart Association (NYHA) class III-IV congestive heart failure; clinically significant arrhythmias.
- Renal: Creatinine clearance ≤ 50 mL/min.
- Hepatic: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase > 3 × Upper Limit of Normal (ULN), or Total Bilirubin > 1.5 × ULN.
- Active liver or biliary disease (exceptions: Gilbert's syndrome, asymptomatic gallstones, liver involvement by lymphoma, or stable chronic liver disease assessed by the investigator).
- History of severe cerebrovascular disease within the past 6 months, or current presence of symptomatic/sequelae cerebrovascular events.
- History of pancreatitis or high-risk factors for pancreatitis.
- Uncontrolled systemic bacterial, fungal, viral, or other severe infections.
- Positive test for Human Immunodeficiency Virus (HIV) or Hepatitis B virus (positive HBsAg or HBcAb).
- Known hypersensitivity to recombinant proteins, murine proteins, or any excipients of the study drugs.
- Female patients who are pregnant, lactating, or planning to become pregnant within 6 months.
- Presence of severe concurrent medical/psychiatric conditions that may compromise patient safety or compliance, or interfere with informed consent, study participation, or interpretation of results.
- Any other conditions that, in the opinion of the investigator, make the patient unsuitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: A Phase II, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Brentuximab Vedotin Combined With Lisaftoclax in Patients With CD30-positive Cutaneous T-cell Lymphoma (CTCL)
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.
Read more
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.
- Conditions
- Cutaneous T-Cell Lymphoma/Mycosis Fungoides, Primary Cutaneous Anaplastic Large Cell Lymphoma
- Being tested
- Brentuximab Vedotin (Bv), Lisaftoclax (APG-2575)
- Medical subject headings
- Mycosis Fungoides, Lymphoma, Primary Cutaneous Anaplastic Large Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab Vedotin (Bv)Drug
Patients will receive brentuximab vedotin intravenously at a dose of 1.8 mg/kg every 3 weeks for a total of 16 cycles.
Lisaftoclax (APG-2575)Drug
Patients will receive Brentuximab Vedotin (1.8 mg/kg, IV, q3w, 16 cycles). Starting from cycle 6, oral Lisaftoclax will be added (600 mg daily on days 1-10 of each 21-day cycle, for 9 cycles, with a daily dose ramp-up in the first cycle).
| Study group | Role | What they receive |
|---|---|---|
| Brentuximab Vedotin Monotherapy | Active comparator | Patients will receive Brentuximab Vedotin intravenously at a dose of 1.8 mg/kg every 3 weeks for a total of 16 cycles. Receives: Drug: Brentuximab Vedotin (Bv) |
| Brentuximab Vedotin + Lisaftoclax | Experimental | Patients will receive brentuximab vedotin at 1.8 mg/kg intravenously every 3 weeks for 16 cycles. Starting from cycle 6, oral lisaftoclax will be added at 600 mg daily on days 1-10 of each 21-day cycle for 9 cycles, with a daily dose ramp-up during the first cycle of lisaftoclax administration. Lisaftoclax is provided by Ascentage Pharma. Receives: Drug: Brentuximab Vedotin (Bv); Drug: Lisaftoclax (APG-2575) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The percentage of participants who achieve a complete response (CR) or partial response (PR) at the end of the treatment, evaluated by independent blinded assessors based on clinical skin assessments and radiological imaging.
Measured: At the end of 16 treatment cycles (up to approximately 48 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T-Cell Lymphoma/Mycosis FungoidesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ascentage Pharma
- Responsible party
- Principal investigator, Yang WANG, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717580
- Sponsor's protocol ID
- CTCL001
- Other IDs
- 82425050
- Acronym
- BV-LISA-CTCL
- Status last verified
- Jun 2026
- First submitted
- 16 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data including baseline characteristics, efficacy and safety outcome data will be shared after study completion and primary publication.