Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory B-NHL

NCT ID: NCT03245905

Last Updated: 2021-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-20
• Study Completion Date: 2021-12-31

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.

Conditions

Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chidamide

Chidamide should be given at a fixed time with fixed dosage

Group Type: EXPERIMENTAL

Chidamide

Intervention Type: DRUG

Chidamide 30mg orally BIW. Treatment cycles are repeated every 3 weeks.The maximum duration of treatment is 2 years.

Interventions

Chidamide

Chidamide 30mg orally BIW. Treatment cycles are repeated every 3 weeks.The maximum duration of treatment is 2 years.

Intervention Type: DRUG

Other Intervention Names

epidaza

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Huiqiang Huang

Chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Medical Oncology, Sun Yat-sen University Cancer Center,

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huiqiang Huang, Professor

Role: CONTACT

huanghq@sysucc.org.cn

+86 020 87343350

Facility Contacts

HuiQiang Huang

Role: primary

huanghq@sysucc.org.cn

86-020-87343350

Other Identifiers

CSIIT-B09

Identifier Type: -

Identifier Source: org_study_id