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

Fujian Medical University

Status and phase: Active, not recruiting; Phase 3

Conditions: Diffuse Large B-cell Lymphoma

Treatments: Drug: R-DA-EPOCH; Drug: R-CEOP90

Study type: Interventional

Funder types: Other

Identifiers

NCT03213977

DLBCL-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 475 estimated patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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475 participants in 2 patient groups

Arm I:R-DA-EPOCH

Active Comparator group

Description:

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

Treatment:

Drug: R-DA-EPOCH

Arm II:R-CEOP90

Experimental group

Description:

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

Treatment:

Drug: R-CEOP90