Clinical trial NCT03213977: R-DA-EDOCH Versus R-CEOP90, With/Without Upfront Auto-HSCT in Young Patients With High-risk DLBCL
Official title: A Multicenter,Randomized, Controlled (Comparative), Open, Prospective Study Evaluating an Efficacy of R-DA-EPOCH and R-CEOP90, With or Without Upfront Auto-HSCT，in Newly Diagnosed Young Patients With High-risk DLBCL
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Diffuse Large B-cell Lymphoma
Keywords: DLBCL, R-DA-EPOCH, R-CEOP90, auto-HSCT
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 475
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: progression-free survival
timeFrame: Two-year survival
Secondary outcomes:
measure: complete response
timeFrame: 6 cycles
measure: overall survival
timeFrame: Two-year survival
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: During the treatment
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Jianda Hu, Prof.
role: PRINCIPAL_INVESTIGATOR
References: