New chemo cocktail aims to treat rare lymphoma without heart damage
NCT ID NCT07535762
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests a new chemotherapy combination called CAOP for elderly patients (65+) with untreated peripheral T-cell lymphoma, a rare blood cancer. The standard treatment often causes heart damage, but this regimen replaces the heart-toxic drug with a safer one. The study will enroll 36 participants to see if the combo can achieve complete remission with fewer side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- aclarubicin, cyclophosphamide, vincristine, and prednisone (CAOP regimen)
- What this could lead to
- If successful, this could offer a safer and effective chemotherapy option for elderly patients with peripheral T-cell lymphoma, potentially improving survival without severe heart damage.
- What could go wrong
- This is a small, early-phase trial with only 36 participants, so results may not apply to all patients. The drug combination may still cause side effects or fail to improve outcomes compared to standard treatments.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 36 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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65 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 ≥ 65 years at enrollment 3. ECOG performance status score ≤ 2 4. Able to comply with the research visit plan and other protocol requirements 5. Patients with histologically confirmed peripheral T-cell lymphoma (PTCL) who have not previously received treatment The following subtypes as defined by the World Health Organization (WHO) classification (2022) are eligible, with Ann Arbor stage I-IV, and pathological immunohistochemical CD30 negative: 1. Peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS) 2. Nodal T-follicular helper cell lymphoma (TFH) 3. Anaplastic large cell lymphoma, ALK-negative (ALCL) 6. Life expectancy ≥ 3 months 7. Hematological, renal, and hepatic function all meet the requirements: 1. Absolute neutrophil count (ANC) ≥ 1,500/μL 2. Platelet count ≥ 100,000/μL 3. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) for the institution (except for patients with Gilbert's syndrome) 4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; if liver involvement is known, then ≤ 5.0 × ULN 5. Serum creatinine ≤ 1.5 × ULN, or creatinine clearance \> 50 mL/min calculated by the Cockcroft-Gault formula Exclusion Criteria: 1. Mental illness, disability, or social circumstances that may affect participant safety, ability to provide informed consent, or poor adherence 2. Other types of lymphoma 3. Previous immunotherapy or chemotherapy for PTCL, excluding those who used corticosteroids (≤8 days) prior to enrollment 4. Previous radiotherapy for PTCL, excluding those confined to a single lymph node region 5. Pathological immunohistochemistry showing CD30 positivity and/or ALK positivity 6. Patients planning to receive autologous or allogeneic transplantation as first-line consolidation therapy 7. Confirmed central nervous system/meningeal involvement 8. Significant uncontrolled comorbidities or infections, specifically: 1. Uncontrolled infection requiring intravenous antibiotics 2. Clinically significant heart disease (NYHA Class III or IV), unstable angina 3. History of angioplasty, stent implantation, or myocardial infarction within the past 6 months 4. Uncontrolled hypertension (systolic blood pressure \>160 mmHg) despite using two antihypertensive medications. (or diastolic blood pressure \>100 mmHg, measured twice consecutively, one week apart) 5. Clinically significant cardiac arrhythmias 6. Uncontrolled diabetes 9. Known or detected positive for human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV-1), hepatitis B, or hepatitis C. 10. Patients diagnosed with malignancy within the past two years. However, the following are excluded: 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 within the past two years, provided there is currently no evidence of active disease.
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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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