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

March 26, 2024 updated by: Jianda Hu, Fujian Medical University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

475

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I:R-DA-EPOCH
Protocol involves 6 cycles. Patients with complete remission or partial remission undergo auto-HSCT after 6 cycles.
Drug: R-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.
Experimental: Arm II:R-CEOP90
Protocol involves 6 cycles. Patients with complete remission or partial remission undergo auto-HSCT after 6 cycles.
Drug: R-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival
Time Frame: Two-year 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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University

Investigators

  • Principal Investigator: Jianda Hu, Prof., Fujian Medical University Union Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2017

Primary Completion (Actual)

July 13, 2023

Study Completion (Estimated)

July 13, 2024

Study Registration Dates

First Submitted

July 3, 2017

First Submitted That Met QC Criteria

July 7, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DLBCL-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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