Chidamide Combined With Clad/Gem/Bu With AutoSCT in R/R Diffuse Large B Cell Lymphoma

NCT03151876 | Unknown Phase 2

• 1 other identifier: ChiCGB-DLBCL
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 18

Brief Summary

The goal of this clinical research study is to evaluate effectiveness and safety of ChiCGB regimen( chidamide, cladribine, gemcitabine and busulfan). Busulfan are designed to kill cancer cells by binding to DNA (the genetic material of cells), which may cause cancer cells to die. Gemcitabine and cladribine are designed to disrupt the growth of cancer cells, which may cause cancer cells to die. It may help to increase the effect of busulfan on cancer cells by not allowing these cells to repair the DNA damage caused by busulfan. Chidamide is designed to open up the DNA and allow greater access to drugs that bind to DNA, such as cladribine, gemcitabine, busulfan.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• Event free survival

  2 years

Secondary Outcomes (3)

• Overall survival

  2 years

• Complete remission

  3 month after autologous hematopoietic stem cell transplantation

• Adverse events

  2 years

Study Arms (1)

ChiCGB

EXPERIMENTAL

Experimental: ChiCGB Chidamide administered orally on D-7, -4, 0,+3 Cladribine administered at 10mg on D-6 to D-2 Gemcitabine administered at 2500 mg/m2 on days -6 and -2. Busulfan administered at 3.2 mg/kg (adjusted ideal body weight) on days -6 to -3. Dexamethasone 10 mg by vein daily from day -6 to day -1. Caphosol oral rinses 30 mL four times a day used from day -8. Interventions: Drug: Chidamide Drug: Cladribine Drug: Gemcitabine Drug: Busulfan Drug: Dexamethasone Procedure: Stem Cell Transplant

Drug: Chidamide; Drug: Cladribine; Drug: gemcitabine; Drug: Busulfan; Procedure: Autologous hematopoietic stem cell transplantation

Interventions

Chidamide DRUG

30 mg oral twice weekly for 2 weeks

ChiCGB

Cladribine DRUG

6 mg/m2 intravenously daily for 5 days

ChiCGB

gemcitabine DRUG

2500 mg/m2 intravenously twice weekly for 1 week

ChiCGB

Busulfan DRUG

3.2 mg/kg intravenously daily for 4 days

ChiCGB

Autologous hematopoietic stem cell transplantation PROCEDURE

autologous hematopoietic stem cells infusion after ChiCGB chemotherapy

ChiCGB

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with primary refractory or recurrent diffuse large B cell lymphoma that do not qualify for treatment protocols of higher priority.
• Relapsed patients should respond to 2nd or 3rd line salvage chemotherapy and attain at least PR before recruitment.
• Adequate renal function, as defined by estimated serum creatinine clearance \>/=50 ml/min and/or serum creatinine \</= 1.8 mg/dL.
• \. Adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) \</= 3 x upper limit of normal; serum bilirubin and alkaline phosphatase \</= 2 x upper limit of normal.
• \. Adequate pulmonary function with forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) \>/= 50% of expected corrected for hemoglobin.
• \. Adequate cardiac function with left ventricular ejection fraction \>/= 50%. No uncontrolled arrhythmias or symptomatic cardiac disease.
• \. Performance status 0-1. 10. Negative Beta diffusing capacity of lung for carbon monoxide (HCG) text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization

You may not qualify if:

• Central nervous system lymphoma
• Patients relapsed after ASCT
• Bone marrow was involved by lymphoma
• Patients with active hepatitis B or C(HBV DNA \>/=10,000 copies/mL).
• Active infection requiring parenteral antibiotics
• HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal cluster of differentiation 4 (CD4) counts
• Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.
• Patients with a cQT longer than 500 ms

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (18)

Beijing cancer hospital

Beijing, Beijing Municipality, 100142, China

NOT YET RECRUITING

Peking university third hospital

Beijing, Beijing Municipality, 100191, China

NOT YET RECRUITING

The first affiliated hospital of Chongqing medical university

Chongqing, Chongqing Municipality, 400016, China

NOT YET RECRUITING

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

General Hospital of Lanzhou military command

Lanzhou, Gansu, 730070, China

NOT YET RECRUITING

Henan cancer hospital

Zhengzhou, Henan, 450008, China

NOT YET RECRUITING

The first affiliated hospital of Zhengzhou university

Zhengzhou, Henan, 450052, China

NOT YET RECRUITING

Tongji Hospital

Wuhan, Hubei, 430030, China

NOT YET RECRUITING

Jiangsu province hospital

Nanjing, Jiangsu, 210029, China

NOT YET RECRUITING

Rui jin hospital Shanghai jiao tong University

Shanghai, Shanghai Municipality, 200025, China

NOT YET RECRUITING

Tong Ren Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Shan Xi Da Yi Hospital

Taiyuan, Shanxi, 030032, China

NOT YET RECRUITING

Tangdu Hospital

Xi’an, Shanxi, 710038, China

NOT YET RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

RECRUITING

Affiliated Hospital of Southwest Medical University

Nanchong, Sichuan, 646000, China

RECRUITING

Blood diseases hospital, Chinese academy of medica

Tianjin, Tianjing, 300020, China

NOT YET RECRUITING

The first affiliated hospital of Xinjiang medical Universtiy

Ürümqi, Xinjiang, 830054, China

NOT YET RECRUITING

Kunming General Hospital of Chengdu Military Area

Kunming, Yunnan, 650032, China

NOT YET RECRUITING

Related Publications (1)

• Ji J, Liu Z, Kuang P, Dong T, Chen X, Li J, Zhang C, Liu J, Zhang L, Shen K, Liu T. A new conditioning regimen with chidamide, cladribine, gemcitabine and busulfan significantly improve the outcome of high-risk or relapsed/refractory non-Hodgkin's lymphomas. Int J Cancer. 2021 Dec 15;149(12):2075-2082. doi: 10.1002/ijc.33761. Epub 2021 Aug 25.

  PMID: 34398971 DERIVED

MeSH Terms

Conditions

Lymphoma

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Cladribine; Gemcitabine; Busulfan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Ting Liu, MD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Ji, MD

CONTACT

86-28-85422370; JieJi@scu.edu.cn

Ting Liu, MD

CONTACT

86-28-85422373; liuting@scu.edu.cn

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: Clinical Professor

Model Details: ChiCGB

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 12, 2017
• Study Start: June 12, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: July 18, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (18)