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

Phase 2

• Conditions: Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
• Interventions: Drug: Chidamide

• Registration Number: NCT03245905
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-10
• Study Start: 2017-08-20
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-12
• Last Update Posted: 2021-03-16
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chidamide	Chidamide	Chidamide should be given at a fixed time with fixed dosage

Primary Outcome Measures

Name	Time	Method
objective response rate（ORR）	every 6 weeks until 2 years after last patient's enrollment	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 Outcome Measures

Name	Time	Method
overall survival（OS）	every 6 weeks until 2 years after last patient's enrollment	Time from randomization to death for any reason Time from randomization to death for any reason Time from randomization to death for any reason Time from randomization to death for any reason
progression-free survival（PFS）	every 6 weeks until 2 years after last patient's enrollment	The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death
Percentage of Participants With Adverse Events (AEs)	Up to 36 months	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Trial Locations

Locations (1)

Department of Medical Oncology, Sun Yat-sen University Cancer Center,; 🇨🇳 Guangzhou, Guangdong, China