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

NCT ID: NCT03105596

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-11
• Study Completion Date: 2019-09-30

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).

Conditions

B-cell Non-Hodgkin's Lymphoma

Study Design

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

Study Groups

Chidamide plus DICE regimen

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

Group Type: EXPERIMENTAL

Chidamide plus DICE Regimen

Intervention Type: DRUG

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.

Interventions

Chidamide plus DICE Regimen

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.

Intervention Type: DRUG

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, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, transformed indolent lymphoma, and other subtypes that investigators consider to be appropriate to be enrolled;

2. Patients must have received at least one systemic treatment (including chemotherapy), but did not achieve remission or had relapse after remission;

3. At least one measurable lesion;

4. Age18-65 years, male or female; ECOG performance status 0-1;

5. Without bone marrow involvement. Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥100 × 109/L, Hb ≥ 90g/L;.

6. Life expectancy no less than 3 months;

7. Not received chemotherapy, targeted medicine or stem cell transplantation 4 weeks before enrollment;

8. Patients have signed the Informed Consent Form.

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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 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. Patients with active infection of HBV, HCV or HIV;

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

11. 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).

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

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

14. Patients who have central nervous system involvements;

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

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Jun Zhu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Central Contacts

Jun Zhu, MD

Role: CONTACT

zj@bjcancer.org

+86-10-88196596

Other Identifiers

Chidamide plus DICE

Identifier Type: -

Identifier Source: org_study_id