LymphomaPhase 2NCT00568815
Rituximab Combined With ESHAP in Patients With Relapse or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
A Phase 2 study testing Rituximab combined with ESHAP in people with Lymphoma, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and toxicity of Rituximab combined with ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin) in the patients with diffuse large B cell lymphoma (DLBCL). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphoma
- What is being tested?
- Rituximab combined with ESHAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- Apr 2007to Dec 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range 18-70 years old
- Histological confirmed diffuse large B cell lymphoma
- ECOG performance status no more than 2
- Life expectancy of more than 3 months
- Relapse or refractory after the first-line chemotherapy of DLBCL
- No evidence of bone marrow involvement
- Normal laboratory values: hemoglobin > 8.0g/dl, neutrophil > 1.5×109/L, platelet > 80×109/L, serum creatine < 1× upper limitation of normal(ULN), serum bilirubin < 1× ULN, ALT and AST < 1.5× ULN
Who cannot join
- Pregnant or lactating women
- Serious uncontrolled diseases and intercurrent infection
- The evidence of CNS metastasis and bone marrow involvement
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Phase II Study of Rituximab Combined With ESHAP in Patients With Relapse or Refractory DLBCL
The purpose of this study is to evaluate the efficacy and toxicity of Rituximab combined with ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin) in the patients with diffuse large B cell lymphoma (DLBCL).
Read the detailed description
The salvage therapy in the patients with DLBCL is still controversial. The investigators conducted this study to evaluate the efficacy and tolerability of Rituximab combined with ESHAP in the patients with DLBCL. The patients enrolled were defined to be relapsed or refractory after the first-line chemotherapy like CHOP or other CHOP-like regimens.
- Conditions
- Lymphoma
- Being tested
- Rituximab combined with ESHAP
- Keywords
- DLBCL, Rituximab, ESHAP, Efficacy, Toxicity
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab combined with ESHAPDrug
Also called R-ESHAP
Rituximab 375mg/m2 d1, VP-16 40mg/m2 d1-4, Ara-C 2g/m2 d5, DDP 25mg/m2 d1-4, Met 500mg/m2 d1-5
| Study group | Role | What they receive |
|---|---|---|
| Chemo | Experimental | Not described Receives: Drug: Rituximab combined with ESHAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: 6 weeks
Secondary outcomes (1)
Toxicities
Measured: every cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study startApr 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ye Guo, Fudan University
- Investigators
- Biyun Wang, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568815
- Sponsor's protocol ID
- ESHAP-DLBCL
- Status last verified
- Feb 2012
- First submitted
- 5 Dec 2007
- Last updated
- 20 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Rituximab Combined With ESHAP in Patients With Relapse or Refractory DLBCL
- ClinicalTrials.gov ID
- NCT00568815
- Acronym / sponsor ID
- ESHAP-DLBCL
- Conditions
- Lymphoma
- Keywords
- DLBCL, Rituximab, ESHAP, Efficacy, Toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Dec 2007 (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 purpose of this study is to evaluate the efficacy and toxicity of Rituximab combined with ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin) in the patients with diffuse large B cell lymphoma (DLBCL).
Detailed description
The salvage therapy in the patients with DLBCL is still controversial. The investigators conducted this study to evaluate the efficacy and tolerability of Rituximab combined with ESHAP in the patients with DLBCL. The patients enrolled were defined to be relapsed or refractory after the first-line chemotherapy like CHOP or other CHOP-like regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemo | Experimental | Drug: Rituximab combined with ESHAP |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age range 18-70 years old
- Histological confirmed diffuse large B cell lymphoma
- ECOG performance status no more than 2
- Life expectancy of more than 3 months
- Relapse or refractory after the first-line chemotherapy of DLBCL
Key exclusion criteria (5 listed)
- Pregnant or lactating women
- Serious uncontrolled diseases and intercurrent infection
- The evidence of CNS metastasis and bone marrow involvement
- 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
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 |
|---|---|---|
| Rituximab combined with ESHAPAlso: R-ESHAPRituximab 375mg/m2 d1, VP-16 40mg/m2 d1-4, Ara-C 2g/m2 d5, DDP 25mg/m2 d1-4, Met 500mg/m2 d1-5 | Drug | Chemo |
Primary outcome
Response rate
Time frame: 6 weeks
1 secondary outcome
Toxicities
Time frame: every cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2012.
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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.
Biyun Wang, M.D. 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 Rituximab combined with ESHAP in people with 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 7 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: finished, as of the sponsor's last update on 20 Feb 2012. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 20 Feb 2012.