Clinical trial · Interventional
Chidamide Maintenance After Autologous Hematopoietic Stem Cell Transplantation for Relapsed, Refractory or High-risk Lymphoma
Chidamide Maintenance Treatment After Autologous Hematopoietic Stem Cell Transplantation in Patients With Relapsed, Refractory or High-risk Lymphoma : a Prospective, Multi-centric, Single Arm, Open Label Phase II Clinical Trial
NCT03611231CI-TRIAL-00034101unknownPhase 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)
Chidamide Maintenance Treatment After Autologous Hematopoietic Stem Cell Transplantation in Patients With Relapsed, Refractory or High-risk Lymphoma : a Prospective, Multi-centric, Single Arm, Open Label Phase II Clinical Trial
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 |
|---|---|---|---|
| Experimental Tumor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- chidamide
- interventionNames
- Drug: Chidamide
Primary outcomes (1)
- measure
- progression-free survival(PFS)
- timeFrame
- up to 2 years
- description
- Time from treatment until disease progression or death
Secondary outcomes (2)
- measure
- overall survival(OS)
- timeFrame
- up to 2 years
- description
- Time from treatment until death from any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with B-NHL,NK/T-NHL and HL were confirmed by histopathology examination had received autologous hematopoietic stem cell transplantation (including secondary transplantation). Transplantation interval was 6-8 weeks before in the study. The first diagnostic risk classification or pre-transplant disease status of each type of lymphoma is as follows: 1)B-NHL: patients who are at high risk according to the corresponding international prognostic index in the first diagnosis(IPI\>3 /aa IPI \>2 /FLIPI\>3); Patients must have received at least one first-line induction therapy but did not achieve CR or had relapse after CR; 2)NK/T-NHL: Including all patients, unlimited risk classification and pre-transplant disease status; 3)HL: Patients must have received at least one first-line induction therapy 2. Age 18-70 years, male or female; 3. ECOG performance status 0-1; 4. Organ function should fit the following : Renal function with serum creatinine \< 160μmol/L; Liver function with Total bilirubin ≤2 times of normal maximum, ALT and AST≤3 times of normal maximum. Adequate pulmonary function with forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) ≥ 50% of expected corrected for hemoglobin. Adequate cardiac function with left ventricular ejection fraction ≥ 50%. No symptomatic cardiac disease; 5. Blood routine test: absolute neutrophil count ≥1.5×109/L, platelet ≥75×109/L, Hb ≥ 90g/L; 6. Life expectancy no less than 3 months; 7. Patients willing to sign the Informed Consent Form. Exclusion Criteria: 1. Patients relapsed after ASCT 2. Patients with HBsAg positive or HBcAb positive patients also detected HBV-DNA copy number positive; 3. Patients with active HCV infection; 4. Patients with active HIV infection; 5. Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue disease, severe infectious diseases and others; 6. Patients with liver cirrhosis or evidence of liver fibrosis; 7. Patients with a QTc longer than 500 ms; 8. Patients with mental disorders or those do not have the ability to consent; 9. Patients with drug abuse, long term alcoholism that may impact the results of the trial; 10. Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures; 11. Non-appropriate patients for the trial according to the judgment of the investigators;
References
Publications (0)
Data not yet available
No reference posted for this study.