Can a Five-Drug combo tame a tough lymphoma without standard chemo?
NCT ID NCT07746245
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether a combination of five drugs—chidamide, azacitidine, prednisone, cyclophosphamide, and thalidomide—can help people with peripheral T-cell lymphoma (PTCL) who are unable to tolerate standard chemotherapy. The study will enroll 58 adults with PTCL, including those who are newly diagnosed or have relapsed/refractory disease. Participants will receive the drug combo in 21-day cycles for up to 6 cycles, followed by a maintenance phase. The main goal is to see how many patients achieve a complete or partial response to the treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of chidamide, azacitidine, prednisone, cyclophosphamide, and thalidomide
- What this could lead to
- If successful, this could offer a new treatment option for people with peripheral T-cell lymphoma who cannot tolerate standard chemotherapy, potentially helping to control the disease.
- What could go wrong
- This is an early-phase, single-arm study without a comparison group, so results may not be definitive. The drug combination may cause side effects, and it's unclear if it will be more effective than existing options.
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 58 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2029
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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18 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\. Patients with histopathologically confirmed peripheral T-cell lymphoma (PTCL), with exclusion of NK/T-cell lymphoma. * 2\. Patients who are treatment-naïve or have relapsed/refractory disease. * 3\. Patients who are intolerant to standard chemotherapy regimens for various reasons, including those aged ≥75 years, or those aged \<75 years but deemed by the investigator to be unsuitable for or unable to tolerate chemotherapy. * 4\. Patients aged ≥18 years, male or female. * 5\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3. * 6\. Absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥50×10⁹/L, and hemoglobin ≥70 g/L. * 7\. Estimated life expectancy ≥3 months. * 8\. Voluntary signing of written informed consent. Exclusion Criteria: * 1\. Pregnant or lactating women, or fertile patients of childbearing potential who are unwilling to adopt contraceptive measures. * 2\. Patients with chronic heart failure of New York Heart Association (NYHA) functional class III or IV; or those with a history of any of the following cardiac conditions within 6 months: acute coronary syndrome; acute heart failure (NYHA functional class III or IV); or significant ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, or sudden cardiac death after resuscitation). * 3\. Hepatic dysfunction (total bilirubin \>1.5× the upper limit of normal \[ULN\]; alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\] \>2.0× ULN, or \>5× ULN in patients with hepatic involvement); or renal dysfunction (serum creatinine \>1.5× ULN). * 4\. Confirmed central nervous system (CNS) involvement by lymphoma. * 5\. Receipt of prior myelosuppressive symptomatic treatment within 7 days before enrollment. * 6\. Active hemorrhage/bleeding. * 7\. Patients with acquired immunodeficiency syndrome (AIDS), syphilis, or active hepatitis B (HBV DNA \>1×10⁵ copies/mL) or hepatitis C. * 8\. Receipt of grade II or higher surgery within 3 weeks prior to treatment. * 9\. Psychiatric disorders or inability to provide informed consent. * 10\. Patients deemed by the investigator to be unsuitable for participation in this trial. * 11\. Known allergy to any component of the investigational drug.
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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
1 site. 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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The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
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