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

NCT03105596 | Unknown Phase 2

• 1 other identifier: Chidamide plus DICE
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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).

Conditions

B-cell Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• objective response rate（ORR）

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

  every 6 weeks until 2 years

Secondary Outcomes (3)

• progression-free survival（PFS）

  2 years

• events-free survival（EFS）

  2 years

• overall survival（OS）

  2 years

Study Arms (1)

Chidamide plus DICE regimen

EXPERIMENTAL

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

Drug: Chidamide plus DICE Regimen

Interventions

Chidamide plus DICE Regimen 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.

Chidamide plus DICE regimen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jun Zhu, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Zhu, MD

CONTACT

+86-10-88196596; zj@bjcancer.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 10, 2017
• Study Start: April 11, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2019
• Last Updated: April 11, 2017

Record last verified: 2017-04