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Chidamide Plus DICE Regimen for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)

Primary Purpose

B-cell Non-Hodgkin's Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Chidamide plus DICE Regimen

About this trial

This is an interventional treatment trial for B-cell Non-Hodgkin's Lymphoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, transformed indolent lymphoma, and other subtypes that investigators consider to be appropriate to be enrolled;
Patients must have received at least one systemic treatment (including chemotherapy), but did not achieve remission or had relapse after remission;
At least one measurable lesion;
Age18-65 years, male or female; ECOG performance status 0-1;
Without bone marrow involvement. Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥100 × 109/L, Hb ≥ 90g/L;.
Life expectancy no less than 3 months;
Not received chemotherapy, targeted medicine or stem cell transplantation 4 weeks before enrollment;
Patients have signed the Informed Consent Form.
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Exclusion Criteria:

Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures.
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;
pericardial effusion ≥10mm sum of echo-free spaces by echocardiography;
Patients have undergone organ transplantation;
Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment.
Patients with active hemorrhage.
Patients with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction.
Patients with active infection, or with continuous fever within 14 days prior to enrollment.
Patients with active infection of HBV, HCV or HIV;
Had major organ surgery within 6 weeks prior to enrollment.
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).
Patients with mental disorders or those do not have the ability to consent.
Patients with drug abuse, long term alcoholism that may impact the results of the trial.
Patients who have central nervous system involvements;
Non-appropriate patients for the trial according to the judgment of the investigators.
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Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chidamide plus DICE regimen

Arm Description

Chidamide combined with DICE (Dexamethasone, Ifosfamide, Cisplatin and Etoposide) regimen

Outcomes

Primary Outcome Measures

objective response rate（ORR）

the total proportion of patients with complete response（CR or CRu）and partial response（PR）

Secondary Outcome Measures

progression-free survival（PFS）

Time from treatment until disease progression or death

events-free survival（EFS）

Time from treatment to disease progression, death, or discontinuation of treatment for any reason

overall survival（OS）

Time from treatment until death from any cause

Full Information

NCT ID

NCT03105596

First Posted

April 4, 2017

Last Updated

April 9, 2017

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT03105596

Brief Title

Chidamide Plus DICE Regimen for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)

Official Title

Study of Chidamide Plus DICE Regimen for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

April 11, 2017 (Anticipated)

Primary Completion Date

September 30, 2018 (Anticipated)

Study Completion Date

September 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide combined with DICE (Dexamethasone, Ifosfamide, Cisplatin and Etoposide) in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma (NHL).

Detailed 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 combined with DICE in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma (NHL).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

B-cell Non-Hodgkin's Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chidamide plus DICE regimen

Arm Type

Experimental

Arm Description

Chidamide combined with DICE (Dexamethasone, Ifosfamide, Cisplatin and Etoposide) regimen

Intervention Type

Drug

Intervention Name(s)

Chidamide plus DICE Regimen

Intervention Description

Chidamide 20mg orally d1, 4, 8, 11, 15, 18; Dexamethasone 10mg，ivg, d1-4; ifosfamide 1g/m2, ivg, d1-4, given over 4 hours; Mesna 0.4g, 0,4,8,12 hours during Ifosfamide transfusion, ivg, d1-4; Cisplatin 25mg/m2, ivg, d1-4; Etoposide 60mg/m2, ivg. d1-4.

Primary Outcome Measure Information:

Title

objective response rate（ORR）

Description

the total proportion of patients with complete response（CR or CRu）and partial response（PR）

Time Frame

every 6 weeks until 2 years

Secondary Outcome Measure Information:

Title

progression-free survival（PFS）

Description

Time from treatment until disease progression or death

Time Frame

2 years

Title

events-free survival（EFS）

Description

Time from treatment to disease progression, death, or discontinuation of treatment for any reason

Time Frame

2 years

Title

overall survival（OS）

Description

Time from treatment until death from any cause

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, transformed indolent lymphoma, and other subtypes that investigators consider to be appropriate to be enrolled; Patients must have received at least one systemic treatment (including chemotherapy), but did not achieve remission or had relapse after remission; At least one measurable lesion; Age18-65 years, male or female; ECOG performance status 0-1; Without bone marrow involvement. Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥100 × 109/L, Hb ≥ 90g/L;. Life expectancy no less than 3 months; Not received chemotherapy, targeted medicine or stem cell transplantation 4 weeks before enrollment; Patients have signed the Informed Consent Form. - Exclusion Criteria: Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures. 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; pericardial effusion ≥10mm sum of echo-free spaces by echocardiography; Patients have undergone organ transplantation; Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment. Patients with active hemorrhage. Patients with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction. Patients with active infection, or with continuous fever within 14 days prior to enrollment. Patients with active infection of HBV, HCV or HIV; Had major organ surgery within 6 weeks prior to enrollment. 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). Patients with mental disorders or those do not have the ability to consent. Patients with drug abuse, long term alcoholism that may impact the results of the trial. Patients who have central nervous system involvements; Non-appropriate patients for the trial according to the judgment of the investigators. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jun Zhu, MD

Phone

+86-10-88196596

zj@bjcancer.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Zhu, MD

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Chidamide Plus DICE Regimen for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)

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