Back to resultsChiCGB vs BEAM in High-risk or R/R Lymphomas
Primary Purpose
Lymphoma, Large B-Cell, Diffuse, Lymphoma, T-Cell
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Chidamide
Cladribine
Gemcitabine
Busulfan
Carmustine
Etoposide
Cytarabine
Melphalan
Autologous hematopoietic stem cell transplant
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Large B-Cell, Diffuse
Eligibility Criteria
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
Sites / Locations
- People's Hospital of Deyang City
- Chengdu Third People's Hospital
- West China Hospital, Sichuan UniversityRecruiting
- Chengdu First People's HospitalRecruiting
- PLA Western Theater Command General HospitalRecruiting
- Dazhou Central Hospital
- Southwest Medical UniversityRecruiting
- Central Hospital of Mianyang CityRecruiting
- Affiliated Hospital of North Sichuan Medical College
- Zigong First People's HospitalRecruiting
- Guangyuan Central HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ChiCGB
BEAM
Arm Description
Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation.
Treated with BCNU, etoposide, cytarabine and melphalan (BEAM) therapy followed by autologous hematopoietic stem cell transplantation.
Outcomes
Primary Outcome Measures
Progression free survival (PFS)
Progression free survival of this group of patients at the end of 2 year
Secondary Outcome Measures
Overall survival (OS)
Overall survival of this group of patients at the end of 2 year
100 day adverse events (AE)
non-hematologic adverse events @ Day +100
100 day complete response (CR) rate
Complete response @ Day +100
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05466318
Brief Title
ChiCGB vs BEAM in High-risk or R/R Lymphomas
Official Title
ChiCGB Versus BEAM With Autologous Stem-Cell Transplantation in High-risk Hodgkin and Non-Hodgkin Lymphoma - A Prospective, Multi-centered, Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Large B-Cell, Diffuse, Lymphoma, T-Cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
306 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ChiCGB
Arm Type
Experimental
Arm Description
Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation.
Arm Title
BEAM
Arm Type
Active Comparator
Arm Description
Treated with BCNU, etoposide, cytarabine and melphalan (BEAM) therapy followed by autologous hematopoietic stem cell transplantation.
Intervention Type
Drug
Intervention Name(s)
Chidamide
Intervention Description
30 mg oral twice weekly for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Cladribine
Intervention Description
6 mg/m2 intravenously once daily @ Day -7 ~ -3
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
2500 mg/m2 intravenously @ Day -7, -3
Intervention Type
Drug
Intervention Name(s)
Busulfan
Intervention Description
3.2 mg/kg intravenously once daily @ Day -7 ~ -4
Intervention Type
Drug
Intervention Name(s)
Carmustine
Intervention Description
300 mg/m2 intravenously @ Day -8
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
200 mg/m2 intravenously once daily @ Day -7 ~ -4
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Description
400 mg/m2 intravenously once daily @ Day -7 ~ -4
Intervention Type
Drug
Intervention Name(s)
Melphalan
Intervention Description
140 mg/m2 intravenously @ Day -3
Intervention Type
Procedure
Intervention Name(s)
Autologous hematopoietic stem cell transplant
Intervention Description
autologous hematopoietic stem cells infusion after ChiCGB or BEAM chemotherapy
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
Progression free survival of this group of patients at the end of 2 year
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Overall survival of this group of patients at the end of 2 year
Time Frame
2 years
Title
100 day adverse events (AE)
Description
non-hematologic adverse events @ Day +100
Time Frame
100 days from transplant
Title
100 day complete response (CR) rate
Description
Complete response @ Day +100
Time Frame
100 days from transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
People's Hospital of Deyang City
City
Deyang
State/Province
Deyang
ZIP/Postal Code
618000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Zhou, MD
Phone
86-0838-2418820
Email
JieZhou@163.com
Facility Name
Chengdu Third People's Hospital
City
Chendu
State/Province
Sichuan
ZIP/Postal Code
610015
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Tan, MD
Phone
86-28-84446038
Email
JingT@sina.com
Facility Name
West China Hospital, Sichuan University
City
Chendu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Ji, MD
Phone
86-28-85422373
Email
jijie@wchscu.cn
Facility Name
Chengdu First People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaiji Zhang, MD
Phone
+86 028-85311726
Email
kaijiZ@163.com
Facility Name
PLA Western Theater Command General Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610083
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hai Yi, MD
Phone
86-028-86570211
Email
HaiYiCD@163.com
Facility Name
Dazhou Central Hospital
City
Dazhou
State/Province
Sichuan
ZIP/Postal Code
635000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaqiong Li, MD
Phone
86-0818-2371651
Email
yqli@163.com
Facility Name
Southwest Medical University
City
Luzhou
State/Province
Sichuan
ZIP/Postal Code
646000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongyun Xing, MD
Phone
86-0830-3161222
Email
hyxing@gmail.com
Facility Name
Central Hospital of Mianyang City
City
Mianyang
State/Province
Sichuan
ZIP/Postal Code
621000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Xu, MD
Phone
+86 816 222 2566
Email
DrFangX@163.com
Facility Name
Affiliated Hospital of North Sichuan Medical College
City
Nanchong
State/Province
Sichuan
ZIP/Postal Code
637000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingli Zou, MD
Phone
86-0817-2239379
Email
XingliZ@sina.com
Facility Name
Zigong First People's Hospital
City
Zigong
State/Province
Sichuan
ZIP/Postal Code
643011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Xiao, MD
Phone
+86 813 210 0694
Email
xiaojian@163.com
Facility Name
Guangyuan Central Hospital
City
Guangyuan
State/Province
Sihcuan
ZIP/Postal Code
628099
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Yuan, MD
Phone
86-0839-3611120
Email
dryingyuan@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Release after the publication of results of this trial
IPD Sharing Time Frame
after the publication of results of this trial
Learn more about this trial
ChiCGB vs BEAM in High-risk or R/R Lymphomas
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