Diffuse Large B-cell LymphomaPhase 2NCT01670370
Trial of R-GemOx Regimen in Previously Untreated Elderly Patients With DLBCL.
A Phase 2 study testing R-GemOx in people with Diffuse Large B-cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
The purpose of this study is to investigate efficacy and safety of GemOx(Gemcitabine and Oxaliplatin) combination with rituximab(R) as first-line treatment of elderly patients with DLBCL Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- R-GemOx
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Dec 2019
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed CD20-positive DLBCL (The germinal center B-cell like (GCB) / non-GCB subtype was determined by immunohistochemistry in paraffin-embedded tissue using CD10, BCL6 and MUM1 protein markers based on Hans's algorithm);
- New-diagnosed and untreated;
- Age older than 70 years or older than 60 years with ECOG PS ≥2;
- Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- Poor hepatic or renal function, defined as total serum bilirubin, transaminases or creatinine over two times of the upper limit of normal concentration;
- Poor cardiac function greater than Grade II according to New York Heart Association Functional Classification;
- Presence of Grade III nervous toxicity over two weeks;
- Hepatitis B virus (HBV) load (HBV DNA) more than 1×105 copies/ml;
- Concomitant malignancy other than DLBCL requiring treatment;
- Concomitant with other hematologic diseases (such as leukemia, hemophilia, primary myelofibrosis) which is unsuitable to be enrolled into this clinical trial;
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- Contraindication to any drug in this regimen;
- Active and severe infectious diseases, such as severe pheumonia or septicaemia;
- Major surgery within three weeks;
- Any medical, psychological or social conditions which might interfere with the investigators' assessment
- In any conditions which investigator considered ineligible for this study.
About this study
Official title: A Prospective, Single-arm, Open-label, Phase 2 Study to Evaluate Efficacy and Safety of R-GemOx Regimen as First-line Treatment in Elderly Patients With Diffuse Large B-cell Lymphoma (DLBCL).
The purpose of this study is to investigate efficacy and safety of GemOx(Gemcitabine and Oxaliplatin) combination with rituximab(R) as first-line treatment of elderly patients with DLBCL
Read the detailed description
Previous studies showed that the combination of rituximab, gemcitabine and oxaliplatin (R-GemOx) achieved high efficacy with a low toxicity profile in relapsed and refractory DLBCL. This regimen might be considered a putative treatment option for elderly patients. To our knowledge, the efficacy and safety of R-GemOx when given as first-line therapy in elderly patients with DLBCL remains unknown. The investigators therefore developed a two-weekly regimen of rituximab combined with GemOx regimen as first line treatment in elderly DLBCL and investigate its efficacy and safety.
Primary Outcome Measures:
- overall response rate
Secondary Outcome Measures:
- progression free survival
- overall survival
- safety and toxicity
Enrollment: 60 Study Start Date: August 2012 Primary Completion Date: Dec 2015
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- R-GemOx
- Keywords
- Rituximab, Gemcitabine, Oxaliplatin, Diffuse large B-cell lymphoma
- 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-GemOxDrug
Also called Rituximab, Gemcitabine, Oxaliplatin
Rituximab Gemcitabine Oxaliplatin
| Study group | Role | What they receive |
|---|---|---|
| Rituximab+Gemcitabine+oxaliplatin (R-GemOx) | Experimental | Rituximab: 375 mg/m2 IV day1, Gemcitabine 1g/m2 IV day 2, oxaliplatin 100mg/m2 IV day2(every 14 days) Receives: Drug: R-GemOx |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
overall response rate after 3 cycles and at the end of R-GemOx regimen.
Measured: at the end of 3 cycles and 6 cycles of R-GemOx regimen(each cycle is 14 days)
Secondary outcomes (3)
progression free survival
from date of inclusion to date of progression, relapse from response, or death from any cause or last follow-up.
Measured: Two-year
overall survival
from the date of inclusion to date of death, irrespective of cause or last follow-up.
Measured: Two-year
The incidence and severity of adverse events
All the treatment related adverse events was evaluated according to common terminology criteria adverse events(CTCAE) version 4.0
Measured: Up to 30 days following the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2015
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WEI XU, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- WEI XU, M.D., Ph.D., Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670370
- Sponsor's protocol ID
- JSPH-001
- Status last verified
- Feb 2019
- First submitted
- 7 Aug 2012
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lopez A, Gutierrez A, Palacios A, Blancas I, Navarrete M, Morey M, Perello A, Alarcon J, Martinez J, Rodriguez J. GEMOX-R regimen is a highly effective salvage regimen in patients with refractory/relapsing diffuse large-cell lymphoma: a phase II study. Eur J Haematol. 2008 Feb;80(2):127-32. doi: 10.1111/j.1600-0609.2007.00996.x. Epub 2007 Nov 20.
PubMed 18005385Meriggi F, Zaniboni A. Gemox: a widely useful therapy against solid tumors-review and personal experience. J Chemother. 2010 Oct;22(5):298-303. doi: 10.1179/joc.2010.22.5.298.
PubMed 21123151Shen QD, Zhu HY, Wang L, Fan L, Liang JH, Cao L, Wu W, Xia Y, Li JY, Xu W. Gemcitabine-oxaliplatin plus rituximab (R-GemOx) as first-line treatment in elderly patients with diffuse large B-cell lymphoma: a single-arm, open-label, phase 2 trial. Lancet Haematol. 2018 Jun;5(6):e261-e269. doi: 10.1016/S2352-3026(18)30054-1. Epub 2018 May 8.
PubMed 29752199
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Open-label, Phase 2 Study to Evaluate Efficacy and Safety of R-GemOx Regimen as First-line Treatment in Elderly Patients With Diffuse Large B-cell Lymphoma (DLBCL).
- ClinicalTrials.gov ID
- NCT01670370
- Acronym / sponsor ID
- JSPH-001
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- Rituximab, Gemcitabine, Oxaliplatin, Diffuse large B-cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 22 Aug 2012 (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 investigate efficacy and safety of GemOx(Gemcitabine and Oxaliplatin) combination with rituximab(R) as first-line treatment of elderly patients with DLBCL
Detailed description
Previous studies showed that the combination of rituximab, gemcitabine and oxaliplatin (R-GemOx) achieved high efficacy with a low toxicity profile in relapsed and refractory DLBCL. This regimen might be considered a putative treatment option for elderly patients. To our knowledge, the efficacy and safety of R-GemOx when given as first-line therapy in elderly patients with DLBCL remains unknown. The investigators therefore developed a two-weekly regimen of rituximab combined with GemOx regimen as first line treatment in elderly DLBCL and investigate its efficacy and safety.
Primary Outcome Measures:
- overall response rate
Secondary Outcome Measures:
- progression free survival
- overall survival
- safety and toxicity
Enrollment: 60 Study Start Date: August 2012 Primary Completion Date: Dec 2015
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab+Gemcitabine+oxaliplatin (R-GemOx) | Experimental | Drug: R-GemOxRituximab: 375 mg/m2 IV day1, Gemcitabine 1g/m2 IV day 2, oxaliplatin 100mg/m2 IV day2(every 14 days) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed CD20-positive DLBCL (The germinal center B-cell like (GCB) / non-GCB subtype was determined by immunohistochemistry in paraffin-embedded tissue using CD10, BCL6 and MUM1 protein markers based on Hans's algorithm);
- New-diagnosed and untreated;
- Age older than 70 years or older than 60 years with ECOG PS ≥2;
- Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.
Key exclusion criteria (11 listed)
- Poor hepatic or renal function, defined as total serum bilirubin, transaminases or creatinine over two times of the upper limit of normal concentration;
- Poor cardiac function greater than Grade II according to New York Heart Association Functional Classification;
- Presence of Grade III nervous toxicity over two weeks;
- Hepatitis B virus (HBV) load (HBV DNA) more than 1×105 copies/ml;
- Concomitant malignancy other than DLBCL requiring treatment;
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-GemOxAlso: Rituximab, Gemcitabine, OxaliplatinRituximab Gemcitabine Oxaliplatin | Drug | Rituximab+Gemcitabine+oxaliplatin (R-GemOx) |
Primary outcome
overall response rate
Time frame: at the end of 3 cycles and 6 cycles of R-GemOx regimen(each cycle is 14 days)
overall response rate after 3 cycles and at the end of R-GemOx regimen.
3 secondary outcomes
progression free survival
Time frame: Two-year
overall survival
Time frame: Two-year
The incidence and severity of adverse events
Time frame: Up to 30 days following the last dose of study drug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Background: PubMed 18005385Lopez A, Gutierrez A, Palacios A, Blancas I, Navarrete M, Morey M, Perello A, Alarcon J, Martinez J, Rodriguez J. GEMOX-R regimen is a highly effective salvage regimen in patients with refractory/relapsing diffuse large-cell lymphoma: a phase II study. Eur J Haematol. 2008 Feb;80(2):127-32. doi: 10.1111/j.1600-0609.2007.00996.x. Epub 2007 Nov 20.
- Background: PubMed 21123151Meriggi F, Zaniboni A. Gemox: a widely useful therapy against solid tumors-review and personal experience. J Chemother. 2010 Oct;22(5):298-303. doi: 10.1179/joc.2010.22.5.298.
- Derived from this study: PubMed 29752199Shen QD, Zhu HY, Wang L, Fan L, Liang JH, Cao L, Wu W, Xia Y, Li JY, Xu W. Gemcitabine-oxaliplatin plus rituximab (R-GemOx) as first-line treatment in elderly patients with diffuse large B-cell lymphoma: a single-arm, open-label, phase 2 trial. Lancet Haematol. 2018 Jun;5(6):e261-e269. doi: 10.1016/S2352-3026(18)30054-1. Epub 2018 May 8.
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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.
WEI XU, M.D., Ph.D. principal investigator
The First Affiliated Hospital with Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing R-GemOx in people with Diffuse Large B-cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University.
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 11 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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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 rate (time frame: at the end of 3 cycles and 6 cycles of R-GemOx regimen(each cycle is 14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01670370, which also lists 3 linked publications.
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 15 Feb 2019.