Back to resultsR-DA-EDOCH Versus R-CEOP90, With/Without Upfront Auto-HSCT in Young Patients With Intermediate/High-risk DLBCL
Primary Purpose
Diffuse Large B-cell Lymphoma
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
R-DA-EPOCH
R-DA-EPOCH + auto-HSCT
R-CEOP90
R-CEOP90 + auto-HSCT
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Large B-cell Lymphoma focused on measuring DLBCL, R-DA-EPOCH, R-CEOP90, auto-HSCT
Eligibility Criteria
Inclusion Criteria:
- Age 16-60 years
- Newly diagnosed DLBCL
- No previous treatment with chemotherapy and/or radiation therapy of DLBCL
- Presence of 2 or more signs of unfavorable prognosis (IPI 2-4)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Life expectancy of ≥ 6 months
- Adequate hematological function
- Offer informed consent
Exclusion Criteria:
- Transformation of mature cell lymphomas in DLBCL
- Pretreated DLBCL
- HIV-associated DLBCL
- Concomitant other cancer
- Congestive heart failure, unstable angina, severe cardiac arrhythmias and conduction disturbances, myocardial infarction
- Renal insufficiency (serum creatinine greater than 0.2 mmol/L) (except cases with specific kidney infiltration, urinary tract compression by tumor conglomerate or presence of uric acid nephropathy due to massive cytolysis syndrome)
- Liver failure (except cases with liver tumor infiltration), acute hepatitis or active phase of chronic hepatitis B or C with serum bilirubin greater than 1.5 standards, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 3 standards, prothrombin index less than 70%
- Severe pneumonia (except cases with specific lungs infiltration), accompanied by respiratory failure (dyspnea > 30 in min., hypoxemia less than 70 mm Hg, when it is impossible to compensate situation in 2-3 days)
- Life-threatening bleeding (gastrointestinal, intracranial), with exception of bleeding due to tumor infiltration of organs (stomach, intestines, uterus, etc.) and disseminated intravascular coagulation due to underlying disease complications after their successful conservative treatment
- Severe mental disorders (delusions, severe depressive syndrome and other manifestations of productive symptoms) not related with specific infiltration of central nervous system
- Decompensated diabetes
- Pregnancy
Sites / Locations
- Fujian Medical University Union HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
Arm I:R-DA-EPOCH
Arm II:R-DA-EPOCH + auto-HSCT
Arm III:R-CEOP90
Arm IV:R-CEOP90 + auto-HSCT
Arm Description
Protocol involves 6 cycles.
Protocol involves 6 cycles. Patients with complete remission or partial remission undergo auto-HSCT after 6 cycles.
Protocol involves 6 cycles.
Protocol involves 6 cycles. Patients with complete remission or partial remission undergo auto-HSCT after 6 cycles.
Outcomes
Primary Outcome Measures
disease-free survival
Time to disease progression is calculated in months from day of enrollment in the study until disease progression, as appropriate
Secondary Outcome Measures
complete response
(physical examination, standard blood tests, including assessment of LDH level, thoracic and abdominal computerized tomography (together with any other anatomic site, as clinically indicated), bone marrow biopsy in case of bone marrow involvement and 18F-fludeoxyglucose positron emission tomography (18FDG-PET) (not mandatory) in case of residual measurable disease at the end of the chemoimmunotherapy)
overall survival
Survival time is calculated in months from day of enrollment in the study until death, as appropriate
Incidence of Treatment-Emergent Adverse Events
Adverse Events (AEs) occurring during the protocol-specified reporting period are documented.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03213977
Brief Title
R-DA-EDOCH Versus R-CEOP90, With/Without Upfront Auto-HSCT in Young Patients With Intermediate/High-risk DLBCL
Official Title
A Multicenter,Randomized, Controlled (Comparative), Open, Prospective Study Evaluating an Efficacy of R-DA-EPOCH and R-CEOP90, With or Without Upfront Auto-HSCT，in Newly Diagnosed Young Patients With Intermediate/High-risk DLBCL
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
July 13, 2023 (Actual)
Study Completion Date
July 13, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical 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
Patients initially are randomized into 4 arms:
Arm I: R-DA-EPOCH; Arm II: R-DA-EPOCH + auto-SCT; Arm III: R-CEOP90; Arm IV: R-CEOP90 + auto-SCT.
Patients who achieved complete remission (CR) or partial remission (PR) after 6 cycles of R-DA-EPOCH or R-CEOP 90, continue to have 2 more cycles for consolidation in each arm (Arm I and Arm III), or undergo stem cell harvest and auto-HSCT following standard institutional protocols. (Arm II and Arm IV).
The overall purpose of the study is to determine if R-CEOP90 followed by auto-HSCT has similar efficacy compared to that with R-DA-EPOCH.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-cell Lymphoma
Keywords
DLBCL, R-DA-EPOCH, R-CEOP90, auto-HSCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
Randomized
Enrollment
475 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I:R-DA-EPOCH
Arm Type
Experimental
Arm Description
Protocol involves 6 cycles.
Arm Title
Arm II:R-DA-EPOCH + auto-HSCT
Arm Type
Experimental
Arm Description
Protocol involves 6 cycles. Patients with complete remission or partial remission undergo auto-HSCT after 6 cycles.
Arm Title
Arm III:R-CEOP90
Arm Type
Active Comparator
Arm Description
Protocol involves 6 cycles.
Arm Title
Arm IV:R-CEOP90 + auto-HSCT
Arm Type
Active Comparator
Arm Description
Protocol involves 6 cycles. Patients with complete remission or partial remission undergo auto-HSCT after 6 cycles.
Intervention Type
Drug
Intervention Name(s)
R-DA-EPOCH
Intervention Description
R-DA-EPOCH-21 treatment without auto-SCT for DLBCL patients age between 16 to 60 years with intermediate and high risk for IPI.
Intervention Type
Drug
Intervention Name(s)
R-DA-EPOCH + auto-HSCT
Intervention Description
R-DA-EPOCH-21 treatment with auto-SCT for DLBCL patients age between 16 to 60 years with intermediate and high risk for IPI.
Intervention Type
Drug
Intervention Name(s)
R-CEOP90
Intervention Description
R-CEOP90 treatment without auto-SCT for DLBCL patients age between 16 to 60 years with intermediate and high risk for IPI.
Intervention Type
Drug
Intervention Name(s)
R-CEOP90 + auto-HSCT
Intervention Description
R-CEOP90 treatment with auto-SCT for DLBCL patients age between 16 to 60 years with intermediate and high risk for IPI.
Primary Outcome Measure Information:
Title
disease-free survival
Description
Time to disease progression is calculated in months from day of enrollment in the study until disease progression, as appropriate
Time Frame
Two-year survival
Secondary Outcome Measure Information:
Title
complete response
Description
(physical examination, standard blood tests, including assessment of LDH level, thoracic and abdominal computerized tomography (together with any other anatomic site, as clinically indicated), bone marrow biopsy in case of bone marrow involvement and 18F-fludeoxyglucose positron emission tomography (18FDG-PET) (not mandatory) in case of residual measurable disease at the end of the chemoimmunotherapy)
Time Frame
168 day
Title
overall survival
Description
Survival time is calculated in months from day of enrollment in the study until death, as appropriate
Time Frame
Two-year survival
Title
Incidence of Treatment-Emergent Adverse Events
Description
Adverse Events (AEs) occurring during the protocol-specified reporting period are documented.
Time Frame
Up tp study day 240
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 16-60 years
Newly diagnosed DLBCL
No previous treatment with chemotherapy and/or radiation therapy of DLBCL
Presence of 2 or more signs of unfavorable prognosis: aaIPI≥2 or aaIPI=1 with Bulk (≥7.5cm)
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Life expectancy of ≥ 6 months
Adequate hematological function
Offer informed consent
Exclusion Criteria:
Transformation of mature cell lymphomas in DLBCL
Pretreated DLBCL
HIV-associated DLBCL
Concomitant other cancer
Congestive heart failure, unstable angina, severe cardiac arrhythmias and conduction disturbances, myocardial infarction
Renal insufficiency (serum creatinine greater than 0.2 mmol/L) (except cases with specific kidney infiltration, urinary tract compression by tumor conglomerate or presence of uric acid nephropathy due to massive cytolysis syndrome)
Liver failure (except cases with liver tumor infiltration), acute hepatitis or active phase of chronic hepatitis B or C with serum bilirubin greater than 1.5 standards, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 3 standards, prothrombin index less than 70%
Severe pneumonia (except cases with specific lungs infiltration), accompanied by respiratory failure (dyspnea > 30 in min., hypoxemia less than 70 mm Hg, when it is impossible to compensate situation in 2-3 days)
Life-threatening bleeding (gastrointestinal, intracranial), with exception of bleeding due to tumor infiltration of organs (stomach, intestines, uterus, etc.) and disseminated intravascular coagulation due to underlying disease complications after their successful conservative treatment
Severe mental disorders (delusions, severe depressive syndrome and other manifestations of productive symptoms) not related with specific infiltration of central nervous system
Decompensated diabetes
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianda Hu, Prof.
Phone
86-13959169016
Email
drjiandahu@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Yang, Prof.
Phone
86-13950210357
Email
yang.hopeting@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianda Hu, Prof.
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianda Hu, Prof.
Phone
86-13959169016
Email
drjiandahu@163.com
First Name & Middle Initial & Last Name & Degree
Ting Yang, Prof.
Phone
86-13950210357
Email
yang.hopeting@gmail.com
First Name & Middle Initial & Last Name & Degree
Jianda Hu, Prof.
12. IPD Sharing Statement
Learn more about this trial
R-DA-EDOCH Versus R-CEOP90, With/Without Upfront Auto-HSCT in Young Patients With Intermediate/High-risk DLBCL
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