Diffuse Large B-cell LymphomaPhase 2NCT01914718
Dose-adjusted EPOCH-R in MYC Positive DLBCL
A Phase 2 study testing DA-EPOCH-R in people with Diffuse Large B-cell Lymphoma, run by Fudan University at 1 site in China.
Trial summary
The aim of this study is to evaluate the efficacy and toxicity of dose-adjusted EPOCH-R in patients with MYC positive diffuse large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- DA-EPOCH-R
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Dec 2017
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously untreated MYC positive diffuse large B-cell lymphoma
- Age range 18-70 years old
- Eastern Cooperative Oncology Group performance status 0-2
- Life expectancy of more than 3 months
- Adequate organ function
Who cannot join
- Primary or secondary central nervous system involvement
- Previous serious cardiac disease
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Pregnant or lactating women
- Serious uncontrolled diseases and intercurrent infection
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Dose-adjusted EPOCH-R in Patients With Diffuse Large B-cell Lymphoma: a Phase II Study
The aim of this study is to evaluate the efficacy and toxicity of dose-adjusted EPOCH-R in patients with MYC positive diffuse large B-cell lymphoma.
Read the detailed description
The prognosis of MYC positive diffuse large B-cell lymphoma (DLBCL) is very poor even treated with R-CHOP regimen. Recently, dose-adjusted EPOCH-R was shown to be effective in patients with DLBCL and relapsed/refractory Burkitt lymphoma. The aim of this study is to evaluate the efficacy and toxicity of dose-adjusted EPOCH-R in patients with MYC positive diffuse large B-cell lymphoma.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- DA-EPOCH-R
- Keywords
- DLBCL, DA-EPOCH-R
- 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.
DA-EPOCH-RDrug
Also called mabthera
rituximab 375mg/m2 IV day 0, etoposide 50mg/m2/d CIV days 1-4, doxorubicin 10mg/m2/d CIV days 1-4, vincristine 0.4mg/m2/d CIV days 1-4, cyclophosphamide 750mg/m2 IV day 5, prednisone 50mg PO days 1-5 twice per day
| Study group | Role | What they receive |
|---|---|---|
| DA-EPOCH-R | Experimental | rituximab 375mg/m2 IV day 0, etoposide 50mg/m2/d CIV days 1-4, doxorubicin 10mg/m2/d CIV days 1-4, vincristine 0.4mg/m2/d CIV days 1-4, cyclophosphamide 750mg/m2 IV day 5, prednisone 50mg PO days 1-5 twice per day Receives: Drug: DA-EPOCH-R |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year progression-free survival
Measured: 3 years
Secondary outcomes (3)
Objective response rate
Measured: 4 months
3-year overall survival
Measured: 3 years
Toxicity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Poor accrual of eligible patients
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.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ye Guo, Fudan University
- Investigators
- Ye Guo, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914718
- Sponsor's protocol ID
- LMTG 13-02
- Status last verified
- Aug 2014
- First submitted
- 2 Mar 2013
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-adjusted EPOCH-R in Patients With Diffuse Large B-cell Lymphoma: a Phase II Study
- ClinicalTrials.gov ID
- NCT01914718
- Acronym / sponsor ID
- LMTG 13-02
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- DLBCL, DA-EPOCH-R
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual of eligible patients
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 Aug 2013 (estimated)
- 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.
The aim of this study is to evaluate the efficacy and toxicity of dose-adjusted EPOCH-R in patients with MYC positive diffuse large B-cell lymphoma.
Detailed description
The prognosis of MYC positive diffuse large B-cell lymphoma (DLBCL) is very poor even treated with R-CHOP regimen. Recently, dose-adjusted EPOCH-R was shown to be effective in patients with DLBCL and relapsed/refractory Burkitt lymphoma. The aim of this study is to evaluate the efficacy and toxicity of dose-adjusted EPOCH-R in patients with MYC positive diffuse large B-cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DA-EPOCH-R | Experimental | Drug: DA-EPOCH-Rrituximab 375mg/m2 IV day 0, etoposide 50mg/m2/d CIV days 1-4, doxorubicin 10mg/m2/d CIV days 1-4, vincristine 0.4mg/m2/d CIV days 1-4, cyclophosphamide 750mg/m2 IV day 5, prednisone 50mg PO days 1-5 twice per day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Previously untreated MYC positive diffuse large B-cell lymphoma
- Age range 18-70 years old
- Eastern Cooperative Oncology Group performance status 0-2
- Life expectancy of more than 3 months
- Adequate organ function
Key exclusion criteria (5 listed)
- Primary or secondary central nervous system involvement
- Previous serious cardiac disease
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Pregnant or lactating women
- Serious uncontrolled diseases and intercurrent infection
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 |
|---|---|---|
| DA-EPOCH-RAlso: mabtherarituximab 375mg/m2 IV day 0, etoposide 50mg/m2/d CIV days 1-4, doxorubicin 10mg/m2/d CIV days 1-4, vincristine 0.4mg/m2/d CIV days 1-4, cyclophosphamide 750mg/m2 IV day 5, prednisone 50mg PO days 1-5 twice per day | Drug | DA-EPOCH-R |
Primary outcome
3-year progression-free survival
Time frame: 3 years
3 secondary outcomes
Objective response rate
Time frame: 4 months
3-year overall survival
Time frame: 3 years
Toxicity
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Poor accrual of eligible patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
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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.
Ye Guo, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DA-EPOCH-R in people with Diffuse Large B-cell Lymphoma, run by Fudan 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 20 Aug 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor accrual of eligible patients). 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?
3-year progression-free survival (time frame: 3 years). 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 20 Aug 2014.