Diffuse Large B-cell LymphomaPhase 3NCT03213977
R-DA-EDOCH Versus R-CEOP90, With/Without Upfront Auto-HSCT in Young Patients With High-risk DLBCL
A Phase 3 study testing R-DA-EPOCH and R-CEOP90 in people with Diffuse Large B-cell Lymphoma, run by Fujian Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- R-DA-EPOCH and R-CEOP90
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 475 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2017to 13 Jul 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- R-DA-EPOCH, R-CEOP90
- Keywords
- DLBCL, R-DA-EPOCH, R-CEOP90, auto-HSCT
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-DA-EPOCHDrug
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.
R-CEOP90Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm I:R-DA-EPOCH | Active comparator | Protocol involves 6 cycles. Patients with complete remission or partial remission undergo auto-HSCT after 6 cycles. Receives: 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. Receives: Drug: R-CEOP90 |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Time to disease progression is calculated in months from day of enrollment in the study until disease progression, as appropriate
Measured: Two-year survival
Secondary outcomes (3)
complete response
(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)
Measured: 6 cycles
overall survival
Survival time is calculated in months from day of enrollment in the study until death, as appropriate
Measured: Two-year survival
Incidence of Treatment-Emergent Adverse Events
Adverse Events (AEs) occurring during the protocol-specified reporting period are documented.
Measured: During the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start10 Jul 2017
- Primary completion13 Jul 2023
- Study completion13 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 475 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianda Hu, Fujian Medical University
- Investigators
- Jianda Hu, Prof., Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213977
- Sponsor's protocol ID
- DLBCL-005
- Status last verified
- Mar 2024
- First submitted
- 3 Jul 2017
- Last updated
- 27 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03213977
- Acronym / sponsor ID
- DLBCL-005
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- DLBCL, R-DA-EPOCH, R-CEOP90, auto-HSCT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 475 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 13 Jul 2023 (actual)
- Study completion
- 13 Jul 2024 (estimated)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I:R-DA-EPOCH | Active comparator | Drug: R-DA-EPOCHProtocol involves 6 cycles. Patients with complete remission or partial remission undergo auto-HSCT after 6 cycles. |
| Arm II:R-CEOP90 | Experimental | Drug: R-CEOP90Protocol involves 6 cycles. Patients with complete remission or partial remission undergo auto-HSCT after 6 cycles. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R-DA-EPOCHR-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. | Drug | Arm I:R-DA-EPOCH |
| R-CEOP90R-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. | Drug | Arm II:R-CEOP90 |
Primary outcome
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
3 secondary outcomes
complete response
Time frame: 6 cycles
overall survival
Time frame: Two-year survival
Incidence of Treatment-Emergent Adverse Events
Time frame: During the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianda Hu, Prof. principal investigator
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing R-DA-EPOCH and R-CEOP90 in people with Diffuse Large B-cell Lymphoma, run by Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: Two-year survival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.