Clinical trial · Interventional
Efficacy and Safety of Chidamide Combined With BEAM Pretreatment Regimen in Autologous Transplantation for T-cell Lymphoma
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
NCT05367856CI-TRIAL-00061140unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This single-center, single-arm clinical study will evaluate the efficacy and safety of Chidamide combined with BEAM Pretreatment Regimen in ASCT treatment of TCL patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| T Cell Lymphoma | T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide combined with BEAM | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chi-BEAM
- description
- Patients in this arm will receive Chidamide Combined With BEAM(Carmustine, Etoposide Cytarabine and Melphalan) as Pretreatment Regimen of ASCT.
- interventionNames
- Drug: Chidamide combined with BEAM
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- Baseline up to data cut-off (up to approximately 2 years)
- description
- Progression-free survival was defined as the time from the date of ASCT until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from an cause, whichever occurred first.
Secondary outcomes (4)
- measure
- Overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.References
Publications (0)
Data not yet available
No reference posted for this study.