Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
306 participants
INTERVENTIONAL
2022-07-01
2025-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Chidamide Combined With Clad/Gem/Bu With AutoSCT in High Risk Hodgkin & Non-Hodgkin Lymphoma
NCT03602131
Chidamide Combined With Clad/Gem/Bu With AutoSCT in R/R Diffuse Large B Cell Lymphoma
NCT03151876
Efficacy and Safety of Chi-BEAC Combining With Auto-HSCT to Treat Aggressive Lymphoma Subjects
NCT03629873
Zevalin/BEAM/Rituximab vs BEAM/Rituximab With or Without Rituximab in Autologous Stem Cell Transplantation
NCT00591630
A Study of ASCT Bridging CART Cell Therapy in Relapsed/Refractory B-cell Lymphoma
NCT04923789
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ChiCGB
Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation.
Chidamide
30 mg oral twice weekly for 2 weeks
Cladribine
6 mg/m2 intravenously once daily @ Day -7 \~ -3
Gemcitabine
2500 mg/m2 intravenously @ Day -7, -3
Busulfan
3.2 mg/kg intravenously once daily @ Day -7 \~ -4
Autologous hematopoietic stem cell transplant
autologous hematopoietic stem cells infusion after ChiCGB or BEAM chemotherapy
BEAM
Treated with BCNU, etoposide, cytarabine and melphalan (BEAM) therapy followed by autologous hematopoietic stem cell transplantation.
Carmustine
300 mg/m2 intravenously @ Day -8
Etoposide
200 mg/m2 intravenously once daily @ Day -7 \~ -4
Cytarabine
400 mg/m2 intravenously once daily @ Day -7 \~ -4
Melphalan
140 mg/m2 intravenously @ Day -3
Autologous hematopoietic stem cell transplant
autologous hematopoietic stem cells infusion after ChiCGB or BEAM chemotherapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Chidamide
30 mg oral twice weekly for 2 weeks
Cladribine
6 mg/m2 intravenously once daily @ Day -7 \~ -3
Gemcitabine
2500 mg/m2 intravenously @ Day -7, -3
Busulfan
3.2 mg/kg intravenously once daily @ Day -7 \~ -4
Carmustine
300 mg/m2 intravenously @ Day -8
Etoposide
200 mg/m2 intravenously once daily @ Day -7 \~ -4
Cytarabine
400 mg/m2 intravenously once daily @ Day -7 \~ -4
Melphalan
140 mg/m2 intravenously @ Day -3
Autologous hematopoietic stem cell transplant
autologous hematopoietic stem cells infusion after ChiCGB or BEAM chemotherapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Relapsed patients should respond to 2nd or 3rd line salvage chemotherapy and attain at least partial response 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 the 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
Exclusion Criteria
* Patients relapsed after autologous stem cell transplantation
* 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 a 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 corrected QT interval(QTc) longer than 500 ms
16 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sichuan University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jie Ji
Principle Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
People's Hospital of Deyang City
Deyang, Deyang, China
Chengdu Third People's Hospital
Chengdu, Sichuan, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Chengdu First People's Hospital
Chengdu, Sichuan, China
PLA Western Theater Command General Hospital
Chengdu, Sichuan, China
Dazhou Central Hospital
Dazhou, Sichuan, China
Southwest Medical University
Luzhou, Sichuan, China
Central Hospital of Mianyang City
Mianyang, Sichuan, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China
Zigong First People's Hospital
Zigong, Sichuan, China
Guangyuan Central Hospital
Guangyuan, Sihcuan, China
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ChiCGB 2.0
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.