Lymphoma, Non-HodgkinPhase 2NCT00367497
Safety and Efficacy Study of Salvage Chemotherapy (R-ESHAP) to Treat Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
A Phase 2 study testing Rituximab, Etoposide, Methylprednisolone, Cytarabine, Cisplatin in people with Lymphoma, Non-Hodgkin, run by Keio University at 1 site in Japan.
Trial summary
Aggressive non-Hodgkin's lymphoma is difficult to handle once it relapses or becomes refractory to chemotherapy. Various second or third line chemotherapies, which are called salvage chemotherapy, were developed without promising results. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- Rituximab, Etoposide, Methylprednisolone, Cytarabine, Cisplatin
- How many people
- 5 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2005to Nov 2007
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of aggressive non-Hodgkin's lymphoma
- Refractory to the first line chemotherapy or relapsed
- Expression of CD20 on lymphoma cells
- Measurable lesions on imaging studies
Who cannot join
- Blood cell counts not reaching to 3,000/microliter for white blood cells, 7 g/dl for hemoglobin, and 50,000/microliter for platelets without transfusion at the time of registration
- Circulating lymphoma cells equal to or more than 25,000/microliter
- Hepatic dysfunction
- Renal insufficiency
- Cardiac dysfunction or arrhythmia
- Sever infection (bacterial, viral)
Show all 9Show fewer
- CNS involvement
- Other malignancies
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Rituximab and ESHAP (Etoposide, Methylprednisolone, Cytarabine, and Cisplatin) in Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
Aggressive non-Hodgkin's lymphoma is difficult to handle once it relapses or becomes refractory to chemotherapy. Various second or third line chemotherapies, which are called salvage chemotherapy, were developed without promising results. Improvement in efficacy by adding relatively new agent, rituximab, to chemotherapy is now widely accepted in non-Hodgkin's lymphoma. This study will test the safety and efficacy of adding rituximab to existing salvage chemotherapy, ESHAP (R-ESHAP). Our aim is also to proceed to high-dose chemotherapy with autologous hematopoietic stem cell transplantation after successful R-ESHAP therapy.
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- Rituximab, Etoposide, Methylprednisolone, Cytarabine, Cisplatin
- Keywords
- aggressive non-Hodgkin's lymphoma, salvage chemotherapy, rituximab
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab, Etoposide, Methylprednisolone, Cytarabine, CisplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response
Secondary outcomes (5)
Complete response
Safety
Overall survival
Progression free survival
Effectiveness of peripheral blood stem cell collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2006 (estimated)
- Study startAug 2005
- Study completionNov 2007
Why it stopped: The stopping rule was applied because of low response rates.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keio University
- Sponsor type
- University, hospital or other
- Investigators
- Norihiro Awaya, MD, PhD, Principal investigator, Keio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367497
- Sponsor's protocol ID
- 17-40
- Status last verified
- Nov 2007
- First submitted
- 22 Aug 2006
- Last updated
- 20 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Rituximab and ESHAP (Etoposide, Methylprednisolone, Cytarabine, and Cisplatin) in Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00367497
- Acronym / sponsor ID
- 17-40
- Conditions
- Lymphoma, Non-Hodgkin
- Keywords
- aggressive non-Hodgkin's lymphoma, salvage chemotherapy, rituximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The stopping rule was applied because of low response rates.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Keio UniversityUniversity, hospital or other
- Study start
- Aug 2005
- Study completion
- Nov 2007 (actual)
- First posted
- 23 Aug 2006 (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.
Aggressive non-Hodgkin's lymphoma is difficult to handle once it relapses or becomes refractory to chemotherapy. Various second or third line chemotherapies, which are called salvage chemotherapy, were developed without promising results. Improvement in efficacy by adding relatively new agent, rituximab, to chemotherapy is now widely accepted in non-Hodgkin's lymphoma. This study will test the safety and efficacy of adding rituximab to existing salvage chemotherapy, ESHAP (R-ESHAP). Our aim is also to proceed to high-dose chemotherapy with autologous hematopoietic stem cell transplantation after successful R-ESHAP therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of aggressive non-Hodgkin's lymphoma
- Refractory to the first line chemotherapy or relapsed
- Expression of CD20 on lymphoma cells
- Measurable lesions on imaging studies
Key exclusion criteria (9 listed)
- Blood cell counts not reaching to 3,000/microliter for white blood cells, 7 g/dl for hemoglobin, and 50,000/microliter for platelets without transfusion at the time of registration
- Circulating lymphoma cells equal to or more than 25,000/microliter
- Hepatic dysfunction
- Renal insufficiency
- Cardiac dysfunction or arrhythmia
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, Etoposide, Methylprednisolone, Cytarabine, Cisplatin | Drug | – |
Primary outcome
Overall response
5 secondary outcomes
Complete response
Safety
Overall survival
Progression free survival
Effectiveness of peripheral blood stem cell collection
Results and safety
The study was stopped early (reason given: The stopping rule was applied because of low response rates.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2007.
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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.
Norihiro Awaya, MD, PhD principal investigator
Keio 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, Etoposide, Methylprednisolone, Cytarabine, Cisplatin in people with Lymphoma, Non-Hodgkin, run by Keio University at 1 site in Japan.
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 4 inclusion and 9 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 Nov 2007. 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 Japan. 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: The stopping rule was applied because of low response rates.). 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?
Overall response. 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 Nov 2007.