Clinical trial NCT03245905: Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory B-NHL
Official title: Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 changes in B-cell lymphoma. Thus, epigenetic agents may offer potential improvment of clinical outcomes. Chidamide is a new type of oral histone deacetylase inhibitor. Our exploratory research found that Chidamide was effect in some relapsed /refractory B cell lymphoma patients

. Thus, we will evaluate the efficacy and safety of Chidamide in the patients with aggressive relapsed refractory B cell lymphoma failed from second line chemotherapy.

Eligibility criteria: 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.

Primary outcomes:
measure: objective response rate（ORR）
timeFrame: every 6 weeks until 2 years after last patient's enrollment
Secondary outcomes:
measure: progression-free survival（PFS）
timeFrame: every 6 weeks until 2 years after last patient's enrollment
measure: overall survival（OS）
timeFrame: every 6 weeks until 2 years after last patient's enrollment
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Medical Oncology, Sun Yat-sen University Cancer Center,
state: Guangdong
Study officials:
References: