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

NCT03213977 | Active Not Recruiting Phase 3

• 1 other identifier: DLBCL-005
• Study Type: interventional
• Target: 475
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Large B-cell Lymphoma

Keywords

DLBCL, R-DA-EPOCH, R-CEOP90, auto-HSCT

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  Time to disease progression is calculated in months from day of enrollment in the study until disease progression, as appropriate

  Two-year survival

Secondary Outcomes (3)

• complete response

  6 cycles

• overall survival

  Two-year survival

• Incidence of Treatment-Emergent Adverse Events

  During the treatment

Study Arms (2)

Arm I:R-DA-EPOCH

ACTIVE COMPARATOR

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

Drug: R-DA-EPOCH

Arm II:R-CEOP90

EXPERIMENTAL

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

Drug: R-CEOP90

Interventions

R-DA-EPOCH 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 I:R-DA-EPOCH

R-CEOP90 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.

Arm II:R-CEOP90

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jianda Hu, Prof.

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 11, 2017
• Study Start: July 10, 2017
• Primary Completion: July 13, 2023
• Study Completion: July 13, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

CN (1)