Combining Chidamide with BEAM for T-cell Lymphoma Treatment

Efficacy and Safety of Chidamide Combined With BEAM(Carmustine, Etoposide Cytarabine and Melphalan) Pretreatment in Autologous Transplantation for T-cell Lymphoma: a Single-center, Single-arm Clinical Study

This study is testing if adding Chidamide to the BEAM treatment can help improve outcomes for patients with T-cell lymphoma who are getting a stem cell transplant.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05367856 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the efficacy and safety of Chidamide in combination with the BEAM pretreatment regimen for patients undergoing autologous stem cell transplantation (ASCT) for T-cell lymphoma. T-cell lymphoma is an aggressive form of non-Hodgkin lymphoma that often has poor outcomes with standard treatments. The study aims to improve survival rates by assessing this new treatment approach in a single-center, single-arm design. Participants will be monitored for treatment response and safety outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with confirmed T-cell lymphoma who have achieved a complete or partial response after first-line treatment.

Not a fit: Patients with certain types of T-cell lymphoma, specifically those with ALK+ anaplastic cell lymphoma and those with serious organ dysfunction, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates for patients with T-cell lymphoma undergoing ASCT.

How similar studies have performed: Previous studies have shown promising results with Chidamide in similar contexts, indicating potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

1. According to world Health Organization (WHO) classification of disease, T cell lymphoma (excepted IPI 0-1 point ALK+ anaplastic cell lymphoma) was confirmed by histology, CR or PR after first-line treatment;
2. 18≤ age ≤65 years old, male or female;
3. ECOG score 0-1;
4. No serious organic lesions in the main organs, meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment) :

   * White blood cell count ≥3.0×109/L, absolute neutrophil count ≥1.5×109/L, Hemoglobin ≥90g/L, platelet ≥75×109/L;

     * Total bilirubin ≤1.5× upper normal value (ULN);

       * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× upper normal value (ULN);

         * Creatinine clearance was 44-133 mmol/L;
5. No cardiac dysfunction;
6. Life expectancy over 3 months;
7. The subject or his/her legal representative must provide written informed consent prior to conducting a special study examination or procedure.

Exclusion Criteria:

1. Central nervous system lymphoma was excluded;
2. Suffering from serious complications or severe infection;
3. A history of other malignant tumors within 5 years, excluding early tumors treated for curative purposes;
4. Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.;
5. HBsAg, HCV or HIV positive. Positive HBV and HCV serology is allowed, but DNA/RNA testing must be negative;
6. Laboratory test value during screening;

   ① Neutrophils \<1.5×109/L; Platelet \<75×109/L;

   ② Bilirubin was 1.5 times higher than the normal upper limit, transaminase was 2.5 times higher than the normal upper limit;

   ③ The creatinine level is higher than 1.5 times the upper limit of normal value;
7. Left ventricular ejection fraction ≦ 50%;
8. Other concurrent and uncontrolled medical conditions considered by the investigator would affect the patient's participation in the study;
9. Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol;
10. Pregnant or lactating women;
11. The researcher judged that the patients were not suitable for this study.

Where this trial is running

Shanghai, Shanghai

• Ruijin Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Weili Zhao

Conditions T Cell Lymphoma; T cell lymphoma; Autologous Stem Cell Transplantation; Chidamide; BEAM