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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05466318
Other study ID # ChiCGB 2.0
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date July 1, 2022
Est. completion date December 30, 2025

Study information

Verified date July 2022
Source Sichuan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

High-dose chemotherapy (HDT) with autologous stem cell transplantation (ASCT) plays a vital role in treating high-risked or relapsed/refractory lymphoma. Our previous study showed chidamide combined with cladribine, gemcitabine, and busulfan (ChiCGB) as conditioning therapy improved the survival of these patients. So we designed this trial to verify if ChiCGB were better than BCNU, etoposide, cytarabine, and melphalan (BEAM). Patients with diffuse large B cell or extra-nodal NK/T cell Lymphoma who consent to this study will be randomized into the trial group who receive ChiCGB or the control group whom receive BEAM. Patients will be followed for up to 2 years after the hematopoietic cell transplantation (HCT).


Recruitment information / eligibility

Status Recruiting
Enrollment 306
Est. completion date December 30, 2025
Est. primary completion date December 30, 2025
Accepts healthy volunteers No
Gender All
Age group 16 Years to 65 Years
Eligibility Inclusion Criteria: - Patients with primary refractory or recurrent diffuse large B cell lymphoma or extra-nodal NK/T 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 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: - Central nervous system lymphoma - 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

Study Design


Intervention

Drug:
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
Procedure:
Autologous hematopoietic stem cell transplant
autologous hematopoietic stem cells infusion after ChiCGB or BEAM chemotherapy

Locations

Country Name City State
China Chengdu Third People's Hospital Chendu Sichuan
China West China Hospital, Sichuan University Chendu 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 People's Hospital of Deyang City Deyang Deyang
China Guangyuan Central Hospital Guangyuan Sihcuan
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

Sponsors (1)

Lead Sponsor Collaborator
Sichuan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression free survival (PFS) Progression free survival of this group of patients at the end of 2 year 2 years
Secondary Overall survival (OS) Overall survival of this group of patients at the end of 2 year 2 years
Secondary 100 day adverse events (AE) non-hematologic adverse events @ Day +100 100 days from transplant
Secondary 100 day complete response (CR) rate Complete response @ Day +100 100 days from transplant
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