Clinical trial · Interventional
Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory B-NHL
Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
NCT03245905CI-TRIAL-00050671unknownPhase 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 is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide as a single-agent treatment in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma (NHL).
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 |
|---|---|---|---|
| Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (NHL) | Non-Hodgkin Lymphoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chidamide
- description
- Chidamide should be given at a fixed time with fixed dosage
- interventionNames
- Drug: Chidamide
Primary outcomes (1)
- measure
- objective response rate(ORR)
- timeFrame
- every 6 weeks until 2 years after last patient's enrollment
- description
- Overall response was determined on the basis of investigator assessments according to lymphoma response to immunomodulatory therapy criteria (LYRIC) for Malignant Lymphoma, 2016. Tumor assessments were performed with CT/MRI with or without PET.
Secondary outcomes (3)
- measure
- progression-free survival(PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosed as B-cell Non-Hodgkin's Lymphoma (NHL) according to "2008 WHO classification of tumors of haematopoietic and lymphoid tissues", including Diffuse Large B-Cell Lymphoma (DLBCL), Mantle Cell Lymphoma (MCL), transformed indolent lymphoma (TL), and other subtypes that investigators consider to be appropriate to be enrolled; 2. Patients achieved CR or PR in previous cytotoxic chemotherapy, and relapsed later than 6 months after remission; 3. Patients with DLBCL, FL grade3, MALT, LPL and SLL received at least two chemotherapy regimens, and Patients with FL grade1-2 received at least three chemotherapy regimens; 4. At least one measurable lesion with a longest diameter \>1.5cm or a short axis \>1.0cm; 5. Age18-75 years; 6. ECOG performance status 0-2; 7. Life expectancy no less than 3 months; 8. Functions within 7 days prior to enrollment: Blood routine test: Hb ≥ 80g/L, absolute neutrophil count ≥1.5 × 109/L, platelet ≥60 × 109/L; Total bilirubin ≤ 1.5 times of normal maximum, ALT/AST≤ 2.5 times of normal maximum, for patients with liver metastasis ALT/AST≤ 5 times of normal maximum; serum creatinin≤1.5 times of normal maximum or CCr≥ 60ml/min; 9. LVEF ≥ 50% by echocardiography; 10. Contraception during and 4 weeks after the study for patients at child bearing age; 11. Patients have signed the Informed Consent Form. Exclusion Criteria: 1. Patients received Chidamide treatment within 6 months prior to enrollment; 2. Patients with Burkitt Lymphoma, B-lymphoblastic lymphoma, central nervous system lymphoma and HIV-Associated Lymphoma; 3. Patients with a "currently active" second malignancy; 4. Patients not recovered from non-hematologic toxicities within 4 weeks prior to enrollment due to chemotherapy, radiation and immunotherapy; 5. Patients receiving or received corticosteroids within 2 weeks prior to enrollment; 6. Patients with cumulative life time dose of Doxorubicin \> 450mg/m2; 7. Patients who have been treated with any investigational drug within 4 weeks prior to enrollment; 8. Women during pregnancy or lactation; 9. Patients with active infection, medical conditions, or mental disorders; 10. Patients with active infection of HBV, HCV or HIV; 11. Congestive heart failure (NYHA grade III/IV), myocardial infarction within 6 months, QTc elongation with clinical significance (≥480ms), hypertension BP≥150/100 mmHg and symptomatic coronary heart disease that require treatment; 12. Patients with drug abuse, long term alcoholism that may impact the results of the trial; 13. 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.