Status:
UNKNOWN
Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory B-NHL
Lead Sponsor:
Sun Yat-sen University
Conditions:
Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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).
Detailed Description
Patients with relapsed /refractory aggressive B cell lymphoma usually have a poor prognosis. These patients cannot be treated successfully or tolered with the conventional chemotherapy. Epigenetic cha...
Eligibility Criteria
Inclusion
- 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;
- Patients achieved CR or PR in previous cytotoxic chemotherapy, and relapsed later than 6 months after remission;
- 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;
- At least one measurable lesion with a longest diameter \>1.5cm or a short axis \>1.0cm;
- Age18-75 years;
- ECOG performance status 0-2;
- Life expectancy no less than 3 months;
- 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;
- LVEF ≥ 50% by echocardiography;
- Contraception during and 4 weeks after the study for patients at child bearing age;
- Patients have signed the Informed Consent Form.
Exclusion
- Patients received Chidamide treatment within 6 months prior to enrollment;
- Patients with Burkitt Lymphoma, B-lymphoblastic lymphoma, central nervous system lymphoma and HIV-Associated Lymphoma;
- Patients with a "currently active" second malignancy;
- Patients not recovered from non-hematologic toxicities within 4 weeks prior to enrollment due to chemotherapy, radiation and immunotherapy;
- Patients receiving or received corticosteroids within 2 weeks prior to enrollment;
- Patients with cumulative life time dose of Doxorubicin \> 450mg/m2;
- Patients who have been treated with any investigational drug within 4 weeks prior to enrollment;
- Women during pregnancy or lactation;
- Patients with active infection, medical conditions, or mental disorders;
- Patients with active infection of HBV, HCV or HIV;
- 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;
- Patients with drug abuse, long term alcoholism that may impact the results of the trial;
- Non-appropriate patients for the trial according to the judgment of the investigators.
Key Trial Info
Start Date :
August 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03245905
Start Date
August 20 2017
End Date
December 31 2021
Last Update
March 16 2021
Active Locations (1)
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1
Department of Medical Oncology, Sun Yat-sen University Cancer Center,
Guangzhou, Guangdong, China, 510060