R-DA-EDOCH Versus R-CEOP90, With/Without Upfront Auto-HSCT in Young Patients With High-risk DLBCL

NCT ID: NCT03213977

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 475 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-10
• Study Completion Date: 2024-07-13

Brief Summary

Patients initially are randomized into 2 arms:

Arm I: R-DA-EPOCH; Arm II: R-CEOP90;

Patients who achieved complete remission (CR) or partial remission (PR) after 6 cycles of R-DA-EPOCH (Arm I) or R-CEOP90 (Arm II), continue to have 2 more cycles for consolidation in each arm, or undergo stem cell harvest and auto-HSCT following standard institutional protocols.

Detailed Description

Patients initially are randomized into 2 arms:

Arm I: R-DA-EPOCH; Arm II: R-CEOP90;

Patients who achieved complete remission (CR) or partial remission (PR) after 6 cycles of R-DA-EPOCH (Arm I) or R-CEOP90 (Arm II), continue to have 2 more cycles for consolidation in each arm, or undergo stem cell harvest and auto-HSCT following standard institutional protocols.

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.

Conditions

Diffuse Large B-cell Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I:R-DA-EPOCH

Protocol involves 6 cycles. Patients with complete remission or partial remission undergo auto-HSCT after 6 cycles.

Group Type: ACTIVE_COMPARATOR

R-DA-EPOCH

Intervention Type: DRUG

R-DA-EPOCH-21 treatment for DLBCL patients between 16 to 60 years with high risk. Patients who meet the criteria for ASCT after reaching CR or PR will undergo ASCT, while those who do not meet the criteria or refuse to undergo ASCT, will continue with 2 cycles of immunochemotherapy.

Arm II:R-CEOP90

Protocol involves 6 cycles. Patients with complete remission or partial remission undergo auto-HSCT after 6 cycles.

Group Type: EXPERIMENTAL

R-CEOP90

Intervention Type: DRUG

R-CEOP90 treatment for DLBCL patients between 16 to 60 years with high risk. Patients who meet the criteria for ASCT after reaching CR or PR will undergo ASCT, while those who do not meet the criteria or refuse to undergo ASCT, will continue with 2 cycles of immunochemotherapy.

Interventions

R-DA-EPOCH

R-DA-EPOCH-21 treatment for DLBCL patients between 16 to 60 years with high risk. Patients who meet the criteria for ASCT after reaching CR or PR will undergo ASCT, while those who do not meet the criteria or refuse to undergo ASCT, will continue with 2 cycles of immunochemotherapy.

Intervention Type: DRUG

R-CEOP90

R-CEOP90 treatment for DLBCL patients between 16 to 60 years with high risk. Patients who meet the criteria for ASCT after reaching CR or PR will undergo ASCT, while those who do not meet the criteria or refuse to undergo ASCT, will continue with 2 cycles of immunochemotherapy.

Intervention Type: DRUG

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jianda Hu

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianda Hu, Prof.

Role: PRINCIPAL_INVESTIGATOR

Fujian Medical University Union Hospital

Locations

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Countries

China

Other Identifiers

DLBCL-005

Identifier Type: -

Identifier Source: org_study_id