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New chemo cocktail aims to treat rare lymphoma without heart damage

NCT ID NCT07535762

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

65 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

    Shanghai, China

  • Ruijin Hospital Wuxi Branch

    Wuxi, China

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