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

Phase 3

Active, not recruiting

• Conditions: Diffuse Large B-cell Lymphoma
• Interventions: Drug: R-DA-EPOCH; Drug: R-CEOP90

• Registration Number: NCT03213977
• Lead Sponsor: Fujian Medical University

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.

Study Timeline

• Study First Submitted: 2017-07-03
• Study First Submitted QC: 2017-07-07
• Study Start: 2017-07-10
• Study First Posted: 2017-07-11
• Primary Completion: 2023-07-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Study Completion: 2024-07-13

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 475

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm I:R-DA-EPOCH	R-DA-EPOCH	Protocol involves 6 cycles. Patients with complete remission or partial remission undergo auto-HSCT after 6 cycles.
Arm II:R-CEOP90	R-CEOP90	Protocol involves 6 cycles. Patients with complete remission or partial remission undergo auto-HSCT after 6 cycles.

Primary Outcome Measures

Name	Time	Method
progression-free survival	Two-year survival	Time to disease progression is calculated in months from day of enrollment in the study until disease progression, as appropriate

Secondary Outcome Measures

Name	Time	Method
complete response	6 cycles	(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	Two-year survival	Survival time is calculated in months from day of enrollment in the study until death, as appropriate
Incidence of Treatment-Emergent Adverse Events	During the treatment	Adverse Events (AEs) occurring during the protocol-specified reporting period are documented.

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China