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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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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
Are there results?: Not yet: the study is under way

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

Other trials in China

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)

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.

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 groups in NCT07717580
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.

31 Jul 202630 Dec 2028

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.
More trials run by Peking University First HospitalThe sponsor's other registered studies.
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)

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.

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
Mycosis Fungoides, Lymphomatoid Papulosis
Not yet recruitingPhase 2
Golidocitinib in Patients With Mycosis Fungoides/Sézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia
Mycosis Fungoides/Sezary Syndrome, T-cell Large Granular Lymphocytic Leukemia
RecruitingObservational study
A Prospective, US-based Study Assessing Mogamulizumab-associated Rash in Patients Diagnosed With Mycosis Fungoides or Sezary Syndrome and Treated With Standard of Care Mogamulizumab
Recurrent Mycosis Fungoides, Recurrent Sezary Syndrome
Active, not recruitingPhase 1
Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome
Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8

All Cutaneous T-Cell Lymphoma/Mycosis Fungoides trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT07717580
Acronym / sponsor ID: BV-LISA-CTCL / CTCL001
Conditions: Cutaneous T-Cell Lymphoma/Mycosis Fungoides, Primary Cutaneous Anaplastic Large Cell Lymphoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 46 participants (estimated)
Lead sponsor: Peking University First HospitalUniversity, hospital or other
Collaborators: Ascentage Pharma
Study start: 31 Jul 2026 (estimated)
Primary completion: 30 Dec 2028 (estimated)
Study completion: 30 Dec 2028 (estimated)
First posted: 21 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Brentuximab Vedotin Monotherapy	Active comparator	Drug: Brentuximab Vedotin (Bv)Patients will receive Brentuximab Vedotin intravenously at a dose of 1.8 mg/kg every 3 weeks for a total of 16 cycles.
Brentuximab Vedotin + Lisaftoclax	Experimental	Drug: Brentuximab Vedotin (Bv), Drug: Lisaftoclax (APG-2575)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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.

Key exclusion criteria (20 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Brentuximab Vedotin (Bv)Patients will receive brentuximab vedotin intravenously at a dose of 1.8 mg/kg every 3 weeks for a total of 16 cycles.	Drug	Brentuximab Vedotin + Lisaftoclax, Brentuximab Vedotin Monotherapy
Lisaftoclax (APG-2575)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).	Drug	Brentuximab Vedotin + Lisaftoclax

Primary outcome

Objective Response Rate (ORR)
Time frame: At the end of 16 treatment cycles (up to approximately 48 weeks)
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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
Individual participant dataSharing planned: Yes. De-identified individual participant data including baseline characteristics, efficacy and safety outcome data will be shared after study completion and primary publication.

Related trials for Cutaneous T-Cell Lymphoma/Mycosis Fungoides

RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
Mycosis Fungoides, Lymphomatoid Papulosis
Not yet recruitingPhase 2
Golidocitinib in Patients With Mycosis Fungoides/Sézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia
Mycosis Fungoides/Sezary Syndrome, T-cell Large Granular Lymphocytic Leukemia
RecruitingObservational study
A Prospective, US-based Study Assessing Mogamulizumab-associated Rash in Patients Diagnosed With Mycosis Fungoides or Sezary Syndrome and Treated With Standard of Care Mogamulizumab
Recurrent Mycosis Fungoides, Recurrent Sezary Syndrome
Active, not recruitingPhase 1
Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome
Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: At the end of 16 treatment cycles (up to approximately 48 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07717580.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.