Chidamide for Patients With Relapse or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma

Experimental Clinical Trial

Official title:

Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03410004
• Other study ID #: CSIIT-B07
• Status: Not yet recruiting
• Phase: Phase 2
• First received: January 12, 2018
• Last updated: January 23, 2018
• Start date: January 25, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: January 2018
• Source: Chinese Academy of Medical Sciences
• Contact: Yuankai Shi, Dr.
• Phone: 010-67781331
• Email: syuankai[@]cicams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study of Chidamide as a single-agent treatment for patients with relapse or refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL)

Description:

Chidamide，a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide as a single-agent treatment in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL). Moreover, the aim was to study the correlation of clinical efficacy to mutation of certain genes as well.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Diagnosed as Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL) according to "2016 WHO classification of tumors of haematopoietic and lymphoid tissues";

2. Patients must have received systemic treatment (including chemotherapy or Hematopoietic stem cell transplantation), but did not achieve remission or had relapse after remission;

3. At least one measurable lesion;

4. Age 18-75 years, male or female;

5. ECOG performance status 0-1;

6. Without bone marrow involvement. Blood routine test: absolute neutrophil count =1.5 × 109/L, platelet =80 × 109/L, Hb = 90g/L;.

7. Life expectancy no less than 3 months;

8. Not received chemotherapy, targeted medicine or stem cell transplantation 3 weeks before enrollment;

9. Patients have signed the Informed Consent Form.

Exclusion Criteria:

1. Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures.

2. QTc elongation with clinical significance ( male? 450ms, female? 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment;

3. pericardial effusion =10mm sum of echo-free spaces by echocardiography;

4. Patients have undergone organ transplantation;

5. Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment.

6. Patients with active hemorrhage.

7. Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction.

8. Patients with active infection, or with continuous fever within 14 days prior to enrollment.

9. Had major organ surgery within 6 weeks prior to enrollment.

10. Impaired liver function ( Total bilirubin ? 1.5 times of normal maximum, ALT/AST? 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST ? 5 times of normal maximum), impaired renal function (serum creatinin? 1.5 times of normal maximum).

11. Patients with mental disorders or those do not have the ability to consent.

12. Patients with drug abuse, long term alcoholism that may impact the results of the trial.

13. Patients who have central nervous system involvements;

14. Non-appropriate patients for the trial according to the judgment of the investigators.

Related Conditions & MeSH terms

• Experimental
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Follicular
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Chidamide
Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate(ORR)	the total proportion of patients with complete response(CR or CRu)and partial response(PR)	up to 2 years
Secondary	Disease Control Rate (DCR)	the total proportion of patients with complete response(CR or CRu), partial response(PR)and Stable Disease(SD)	up to 2 years
Secondary	progression-free survival(PFS)	Time from treatment until disease progression or death	2 years
Secondary	overall survival(OS)	Time from treatment until death from any cause	2 years