Diffuse Large B-cell Lymphoma
Conditions
Keywords
DLBCL, R-DA-EPOCH, R-CEOP90, auto-HSCT
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.
Interventions
DRUGR-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.
DRUGR-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.
Sponsors
Fujian Medical University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed