New drug cocktail aims to tackle tough skin cancer
NCT ID NCT07535710
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of four chemotherapy drugs (aclarubicin, cyclophosphamide, vincristine, and prednisone) in people with cutaneous T-cell lymphoma that has come back or not responded to prior treatment. The trial has two phases: first, finding the safest dose of aclarubicin, and second, measuring how many patients see their tumors shrink. About 37 adults aged 60 and older will take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Aclarubicin (a type of chemotherapy) combined with cyclophosphamide, vincristine, and prednisone
- What this could lead to
- If successful, this could provide a new chemotherapy option for patients with cutaneous T-cell lymphoma that has stopped responding to other treatments.
- What could go wrong
- This is an early-phase trial with only 37 participants, so results may not apply to everyone. The drug combination may cause side effects or not work as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 37 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Understand and voluntarily sign the informed consent form 2. Age ≥ 60 years at enrollment 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 4. Histologically confirmed primary cutaneous T-cell lymphoma (CTCL) or Sézary syndrome (SS) (according to the fifth edition of the WHO Classification of Tumors of the Hematopoietic and Lymphoid System) 5. Stage II-B, III, or IV (referring to the Olsen criteria of the International Society for Cancer Research (ISCL)/USCC/EORTC, 2022) 6. Patients who have failed at least one systemic therapy; psoralen combined with ultraviolet radiation therapy (PUVA) is not considered a systemic therapy 7. All clinically significant toxicities caused by previous anticancer therapy have resolved to ≤ Grade 1 (according to NCI-CTCAE v5.0 criteria) 8. Hematological, renal, and liver function tests meet the following requirements: 1. Absolute neutrophil count (ANC) ≥ 1,500 cells/μL 2. Platelet count ≥ 100,000 cells/μL 3. For patients with known bone marrow involvement, ANC ≥ 1,000 cells/μL and platelets ≥ 75,000 cells/μL 4. Total bilirubin ≤ 1.5 times the institutional upper limit of normal (ULN) (except for patients with Gilbert syndrome) 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; if liver involvement is known in C TCL, ≤ 5.0 × ULN 6. Serum creatinine ≤ 1.5 × ULN, or creatinine clearance calculated by the Cockcroft-Gault formula \> 50 mL/min Exclusion Criteria: 1. Patients diagnosed with a malignancy within the past two years. Exclude the following situation: non-melanoma skin cancer, melanoma in situ, localized prostate cancer (current PSA \<0.1 ng/mL), treated thyroid cancer; or cervical carcinoma in situ or breast ductal/lobular carcinoma in situ diagnosed within the past two years, as long as there is no current evidence of active disease. 2. Clinical evidence of central nervous system (CNS) infiltration. 3. Large cell transformation (LCT). Patients with a history of LCT but no current invasive disease and no evidence of LCT on skin or lymph node pathology may be enrolled. 4. Psychiatric illness, disability, or social circumstances that may affect the subject's safety, ability to provide informed consent, or poor compliance. 5. Patients with significant uncontrolled comorbidities or infections, as follows: 1. Uncontrolled infection requiring intravenous antibiotics 2. Clinically significant heart disease (New York Heart Association class III or IV), unstable angina 3. History of angioplasty, stent implantation, or myocardial infarction within 6 months 4. Uncontrolled hypertension despite treatment with two antihypertensive medications (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg, measured on two consecutive occasions, one week apart) 5. Clinically significant arrhythmias 6. Uncontrolled diabetes mellitus 6. Known or tested positive for human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV-1), hepatitis B, or hepatitis C. 7. Active herpes simplex or herpes zoster. Patients who have started antiviral prophylaxis ≥30 days prior to the pretreatment visit, have no signs of active infection, and whose last active infection occurred more than 6 months ago may be enrolled and must continue taking prescribed medications during the study. 8. Known active autoimmune disease (e.g., Graves' disease, systemic lupus erythematosus, rheumatoid arthritis, Crohn's disease, psoriasis). 9. Allergic reaction to study medications. 10. History of allogeneic transplantation. 11. Pregnancy (confirmed by β-hCG) or lactation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai
Shanghai, China
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Ruijin Hospital Wuxi Branch
Wuxi, China
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