Diffuse Large B-cell LymphomaPhase 2NCT01278602
R-ESHAP Followed by Autologous Transplantation for Refractory or Relapsed Diffused Large B-cell Lymphoma
A Phase 2 study testing R-ESHAP in people with Diffuse Large B-cell Lymphoma, run by Fudan University at 1 site in China.
Trial summary
The aim of study is to prove R-ESHAP regimen followed by autologous stem cell transplantation as salvage treatment in patients with refractory or relapsed diffuse large B-cell lymphoma is effective. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- R-ESHAP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Dec 2010to Feb 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: 18-65 years old
- Histological confirmed diffuse large B-cell lymphoma
- Refractory or first relapsed disease
- Prior anthracycline exposure
- Measurable disease
- ECOG performance status 0-1
Show all 11Show fewer
- Life expectancy of more than 3 months
- Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧90g/L
- Liver function: total bilirubin, ALT and AST <1.5×UNL
- Renal function: Cr<1.5×UNL, CCR≧50ml/min
- No contraindication for transplantation
Who cannot join
- Evidence of CNS and bone marrow involvement
- More than 1 type of chemotherapy regimens exposure
- High level of HBV DNA
- Contraindication of high-dose methylprednisolone
- Pregnant or lactating women
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- History of allergic reaction/hypersensitivity to rituximab
- Significant active infection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Ye Guo, MD, pattrick_guo@msn.com
Ye Guo, MD
About this study
Official title: A Multi-center Phase II Study of R-ESHAP Followed by Autologous Transplantation as Salvage Treatment for Patients With Refractory or Relapsed Diffuse Large B-cell Lymphoma.
The aim of study is to prove R-ESHAP regimen followed by autologous stem cell transplantation as salvage treatment in patients with refractory or relapsed diffuse large B-cell lymphoma is effective.
Read the detailed description
The standard treatment in patients with refractory or relapsed diffuse large B-cell lymphoma is salvage chemotherapy followed by autologous transplantation for responsive patients. However, the standard of salvage chemotherapy remains uncertain. This study is to evaluate the efficacy and safety of R-ESHAP regimen in a multi-center basis.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- R-ESHAP
- Keywords
- Diffuse large B-cell lymphoma, Chemotherapy, R-ESHAP, Autologous stem cell transplantation
- 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-ESHAPDrug
Also called Mabthera
Rituximab 375mg/m2 at day 0, Meththylprednisolone 500mg IV at days 1 to 5, Etoposide 40mg/m2 at days 1 to 4, Cisplatin 25mg/m2 at days 1 to 4, Cytarabine 2000mg/m2 at day 5. Frequence of cycles: every 3 weeks. Numbers of cycles: 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| R-ESHAP | Experimental | Rituximab 375mg/m2 at day 0, Meththylprednisolone 500mg IV at days 1 to 5, Etoposide 40mg/m2 at days 1 to 4, Cisplatin 25mg/m2 at days 1 to 4, Cytarabine 2000mg/m2 at day 5. Frequence of cycles: every 3 weeks. Numbers of cycles: 3 cycles. Receives: Drug: R-ESHAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: 6 weeks
Secondary outcomes (2)
3-year progression-free survival rate
Measured: 3 years
3-y overall survival rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2013 (estimated)
- Study completionFeb 2014 (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.
- 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
- 50 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
- NCT01278602
- Sponsor's protocol ID
- LMTG 11-01
- Status last verified
- Mar 2013
- First submitted
- 18 Jan 2011
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Phase II Study of R-ESHAP Followed by Autologous Transplantation as Salvage Treatment for Patients With Refractory or Relapsed Diffuse Large B-cell Lymphoma.
- ClinicalTrials.gov ID
- NCT01278602
- Acronym / sponsor ID
- LMTG 11-01
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- Diffuse large B-cell lymphoma, Chemotherapy, R-ESHAP, Autologous stem cell transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 19 Jan 2011 (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 study is to prove R-ESHAP regimen followed by autologous stem cell transplantation as salvage treatment in patients with refractory or relapsed diffuse large B-cell lymphoma is effective.
Detailed description
The standard treatment in patients with refractory or relapsed diffuse large B-cell lymphoma is salvage chemotherapy followed by autologous transplantation for responsive patients. However, the standard of salvage chemotherapy remains uncertain. This study is to evaluate the efficacy and safety of R-ESHAP regimen in a multi-center basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R-ESHAP | Experimental | Drug: R-ESHAPRituximab 375mg/m2 at day 0, Meththylprednisolone 500mg IV at days 1 to 5, Etoposide 40mg/m2 at days 1 to 4, Cisplatin 25mg/m2 at days 1 to 4, Cytarabine 2000mg/m2 at day 5. Frequence of cycles: every 3 weeks. Numbers of cycles: 3 cycles. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age range: 18-65 years old
- Histological confirmed diffuse large B-cell lymphoma
- Refractory or first relapsed disease
- Prior anthracycline exposure
- Measurable disease
Key exclusion criteria (8 listed)
- Evidence of CNS and bone marrow involvement
- More than 1 type of chemotherapy regimens exposure
- High level of HBV DNA
- Contraindication of high-dose methylprednisolone
- Pregnant or lactating women
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-ESHAPAlso: MabtheraRituximab 375mg/m2 at day 0, Meththylprednisolone 500mg IV at days 1 to 5, Etoposide 40mg/m2 at days 1 to 4, Cisplatin 25mg/m2 at days 1 to 4, Cytarabine 2000mg/m2 at day 5. Frequence of cycles: every 3 weeks. Numbers of cycles: 3 cycles. | Drug | R-ESHAP |
Primary outcome
Overall response rate
Time frame: 6 weeks
2 secondary outcomes
3-year progression-free survival rate
Time frame: 3 years
3-y overall survival rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
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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 R-ESHAP 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 11 inclusion and 8 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 5 Mar 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: 6 weeks). 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 5 Mar 2013; AzTrials last refreshed its copy on 7 Nov 2026.