Diffuse Large B Cell LymphomaPhase 3NCT02767674
Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
A Phase 3 study testing Rituximab, Gemcitabine and Oxaliplatin in people with Diffuse Large B Cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University at 6 sites in China.
Trial summary
The purpose of this study is to investigate efficacy and safety of R-GemOx Versus R-miniCHOP as first-line treatment of elderly patients with Diffuse large B cell lymphoma Read more about this study
- Who is it for?
- Ages 70 to 90 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Rituximab, Gemcitabine and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 6 sitesChina
- Study dates
- May 2016to Dec 2020
- Phase
- Phase 3
- 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 70 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically confirmed diffuse large B cell lymphoma（With exception of Primary mediastinal large B cell lymphoma、Primary central nervous system lymphoma、HIV-related lymphoma);
- New-diagnosed and untreated;
- Age older than 80 years or older than 70 years with ECOG PS ≥ 2;
- Ann Arbor stage I to stage IV disease;
- 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 and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level, unless these abnormalities were related to the lymphoma;
- Poor bone-marrow reserve, defined as neutrophil count less than 1.5×10⁹/L or platelet count less than 75×10⁹/L, unless caused by bone marrow infiltration;
- Presence of Grade III nervous toxicity with two weeks;
- New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome、acute heart failure、severe ventricular arrhythmia
- Positive HIV, syphilis,HCV, or HBV virus load(HBV DNA)> 1×10'4copies/ml;
- CNS or meningeal involvement;
Show all 13Show fewer
- Concomitant malignancy other than aggressive B cell lymphoma and need to Treat, with the exception of non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma,or history of cancer more than 5 years;
- Concomitant with other hematologic diseases(such as leukemia, hemophilia primary myelofibrosis) which investigator it unsuitable to be enrolled into this clinical trial;
- Active and severe infectious diseases;
- Major surgery within three weeks;
- Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment.
- In any conditions which investigator considered ineligible for this study.
- Known sensitivity or allergy to investigational Product.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
QiLu Hospital of Shandong University
Jinan, Shandong, 250012
Luqun Wang, M.D., Ph.D.
- Recruiting
Shandong Province Hospital
Jinan, Shandong, 250021
Xin Wang, M.D., Ph.D.
- Recruiting
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Nanjing, Jiangsu, 21002
Huayuan Zhu, M.D., Ph.D., +86 68136034, huayuan.zhu@hotmail.com
Wei Xu, M.D., Ph.D.
- Recruiting
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Weili Zhao, M.D., Ph.D.
- Recruiting
Sudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200433
Ye Guo, M.D., Ph.D.
- Recruiting
Tongji Medical College of HUST
Wuhan, Hubei, 430030
Jianfeng Zou
About this study
Official title: Phase III,Randomized Controlled Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
The purpose of this study is to investigate efficacy and safety of R-GemOx Versus R-miniCHOP as first-line treatment of elderly patients with Diffuse large B cell lymphoma
Read the detailed description
Gemcitabine and Oxaliplatin(GemOx) shows effective activity in patients with relapsed diffuse large-cell lymphoma and other solid tumors. Our Previous study showed that two-weekly regimen of rituximab combined with GemOx regimen acheived comparable response rate to R-miniCHOP.The investigators therefore design this open-label,phase III and random trial to compared the safety and efficacy of R-Gemox versus R-miniCHOP as first-line treatment of elderly patients with diffuse large B cell lymphoma.
Primary Outcome Measures:
- 2-year overall survival rate
Secondary Outcome Measures:
- 2-year progression free survival rate
- overall response rate
- safety and toxicity Enrollment:258 Study Start Date: June 2016 Primary Completion Date: June 2019
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Rituximab, Gemcitabine, Oxaliplatin, Cyclophosphamide, Epirubicin Injectable Product
- Keywords
- R-Gemox, R-miniCHOP, elderly patients with 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.
RituximabDrug
375 mg/m2 IVD day0
GemcitabineDrug
Gemcitabine 1 g/m2 IVD day 1
OxaliplatinDrug
Oxaliplatin 100 mg/m2 IVD day1
CyclophosphamideDrug
Cyclophosphamide 400 mg/m2 IVD d1
Epirubicin Injectable ProductDrug
Epirubicin 35 mg/m2 IVD d1
VindesineDrug
Vindesine 2 mg IVP d1
PrednisoneDrug
Prednisone 40mg/m2 PO d1-5
| Study group | Role | What they receive |
|---|---|---|
| R-GemOx | Experimental | Rituximab: 375 mg/m2 IV day0, Gemcitabine 1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1(every 14 days) Receives: Drug: Rituximab; Drug: Gemcitabine; Drug: Oxaliplatin |
| R-miniCHOP | Active comparator | Rituximab, 375 mg/m2 IV d0 Cyclophosphamide 400 mg/m2 IV d1 Epirubicin 35 mg/m2 IV d1 vindesine 2 mg IVP d1 Prednisone 40mg/m2 PO d1-5(every 21 days a cycle) Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Epirubicin Injectable Product; Drug: Vindesine; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year overall survival rate
from the date of inclusion to date of death, irrespective of cause
Measured: One year
Secondary outcomes (2)
2-year progression free survival rate
from date of inclusion to date of progression, relapse, or death from any causePFS：from date of inclusion to date of progression, relapse, or death from any cause
Measured: One year
overall response rate
overall response rate after treated by R-GemOx or R-miniCHOP overall response rate after treated by R-GemOx or R-miniCHOP regimen
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 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 Of Nanjing Medical University(JiangSu Province Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767674
- Sponsor's protocol ID
- JSPH-002
- Status last verified
- Jan 2019
- First submitted
- 7 May 2016
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Reyes F, Lederlin P, Gisselbrecht C. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jan 24;346(4):235-42. doi: 10.1056/NEJMoa011795.
PubMed 11807147Oyama T, Yamamoto K, Asano N, Oshiro A, Suzuki R, Kagami Y, Morishima Y, Takeuchi K, Izumo T, Mori S, Ohshima K, Suzumiya J, Nakamura N, Abe M, Ichimura K, Sato Y, Yoshino T, Naoe T, Shimoyama Y, Kamiya Y, Kinoshita T, Nakamura S. Age-related EBV-associated B-cell lymphoproliferative disorders constitute a distinct clinicopathologic group: a study of 96 patients. Clin Cancer Res. 2007 Sep 1;13(17):5124-32. doi: 10.1158/1078-0432.CCR-06-2823.
PubMed 17785567Peyrade F, Jardin F, Thieblemont C, Thyss A, Emile JF, Castaigne S, Coiffier B, Haioun C, Bologna S, Fitoussi O, Lepeu G, Fruchart C, Bordessoule D, Blanc M, Delarue R, Janvier M, Salles B, Andre M, Fournier M, Gaulard P, Tilly H; Groupe d'Etude des Lymphomes de l'Adulte (GELA) investigators. Attenuated immunochemotherapy regimen (R-miniCHOP) in elderly patients older than 80 years with diffuse large B-cell lymphoma: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2011 May;12(5):460-8. doi: 10.1016/S1470-2045(11)70069-9. Epub 2011 Apr 7.
PubMed 21482186Lopez 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 18005385Cabanillas F. Rituximab in DLBCL: 6 years on. Lancet Oncol. 2011 Oct;12(11):984-5. doi: 10.1016/S1470-2045(11)70251-0. Epub 2011 Sep 21. No abstract available.
PubMed 21940215Park S, Lee J, Ko YH, Han A, Jun HJ, Lee SC, Hwang IG, Park YH, Ahn JS, Jung CW, Kim K, Ahn YC, Kang WK, Park K, Kim WS. The impact of Epstein-Barr virus status on clinical outcome in diffuse large B-cell lymphoma. Blood. 2007 Aug 1;110(3):972-8. doi: 10.1182/blood-2007-01-067769. Epub 2007 Mar 30.
PubMed 17400912
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III,Randomized Controlled Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT02767674
- Acronym / sponsor ID
- JSPH-002
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- R-Gemox, R-miniCHOP, elderly patients with diffuse large B cell lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 May 2016 (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 R-GemOx Versus R-miniCHOP as first-line treatment of elderly patients with Diffuse large B cell lymphoma
Detailed description
Gemcitabine and Oxaliplatin(GemOx) shows effective activity in patients with relapsed diffuse large-cell lymphoma and other solid tumors. Our Previous study showed that two-weekly regimen of rituximab combined with GemOx regimen acheived comparable response rate to R-miniCHOP.The investigators therefore design this open-label,phase III and random trial to compared the safety and efficacy of R-Gemox versus R-miniCHOP as first-line treatment of elderly patients with diffuse large B cell lymphoma.
Primary Outcome Measures:
- 2-year overall survival rate
Secondary Outcome Measures:
- 2-year progression free survival rate
- overall response rate
- safety and toxicity Enrollment:258 Study Start Date: June 2016 Primary Completion Date: June 2019
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R-GemOx | Experimental | Drug: Rituximab, Drug: Gemcitabine, Drug: OxaliplatinRituximab: 375 mg/m2 IV day0, Gemcitabine 1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1(every 14 days) |
| R-miniCHOP | Active comparator | Drug: Rituximab, Drug: Cyclophosphamide, Drug: Epirubicin Injectable Product, Drug: Vindesine, Drug: PrednisoneRituximab, 375 mg/m2 IV d0 Cyclophosphamide 400 mg/m2 IV d1 Epirubicin 35 mg/m2 IV d1 vindesine 2 mg IVP d1 Prednisone 40mg/m2 PO d1-5(every 21 days a cycle) |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed diffuse large B cell lymphoma（With exception of Primary mediastinal large B cell lymphoma、Primary central nervous system lymphoma、HIV-related lymphoma);
- New-diagnosed and untreated;
- Age older than 80 years or older than 70 years with ECOG PS ≥ 2;
- Ann Arbor stage I to stage IV disease;
- Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.
Key exclusion criteria (13 listed)
- Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level, unless these abnormalities were related to the lymphoma;
- Poor bone-marrow reserve, defined as neutrophil count less than 1.5×10⁹/L or platelet count less than 75×10⁹/L, unless caused by bone marrow infiltration;
- Presence of Grade III nervous toxicity with two weeks;
- New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome、acute heart failure、severe ventricular arrhythmia
- Positive HIV, syphilis,HCV, or HBV virus load(HBV DNA)> 1×10'4copies/ml;
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 |
|---|---|---|
| Rituximab375 mg/m2 IVD day0 | Drug | R-GemOx, R-miniCHOP |
| GemcitabineGemcitabine 1 g/m2 IVD day 1 | Drug | R-GemOx |
| OxaliplatinOxaliplatin 100 mg/m2 IVD day1 | Drug | R-GemOx |
| CyclophosphamideCyclophosphamide 400 mg/m2 IVD d1 | Drug | R-miniCHOP |
| Epirubicin Injectable ProductEpirubicin 35 mg/m2 IVD d1 | Drug | R-miniCHOP |
| VindesineVindesine 2 mg IVP d1 | Drug | R-miniCHOP |
| PrednisonePrednisone 40mg/m2 PO d1-5 | Drug | R-miniCHOP |
Primary outcome
2-year overall survival rate
Time frame: One year
from the date of inclusion to date of death, irrespective of cause
2 secondary outcomes
2-year progression free survival rate
Time frame: One year
overall response rate
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Results publication: PubMed 11807147Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Reyes F, Lederlin P, Gisselbrecht C. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jan 24;346(4):235-42. doi: 10.1056/NEJMoa011795.
- Results publication: PubMed 17785567Oyama T, Yamamoto K, Asano N, Oshiro A, Suzuki R, Kagami Y, Morishima Y, Takeuchi K, Izumo T, Mori S, Ohshima K, Suzumiya J, Nakamura N, Abe M, Ichimura K, Sato Y, Yoshino T, Naoe T, Shimoyama Y, Kamiya Y, Kinoshita T, Nakamura S. Age-related EBV-associated B-cell lymphoproliferative disorders constitute a distinct clinicopathologic group: a study of 96 patients. Clin Cancer Res. 2007 Sep 1;13(17):5124-32. doi: 10.1158/1078-0432.CCR-06-2823.
- Results publication: PubMed 21482186Peyrade F, Jardin F, Thieblemont C, Thyss A, Emile JF, Castaigne S, Coiffier B, Haioun C, Bologna S, Fitoussi O, Lepeu G, Fruchart C, Bordessoule D, Blanc M, Delarue R, Janvier M, Salles B, Andre M, Fournier M, Gaulard P, Tilly H; Groupe d'Etude des Lymphomes de l'Adulte (GELA) investigators. Attenuated immunochemotherapy regimen (R-miniCHOP) in elderly patients older than 80 years with diffuse large B-cell lymphoma: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2011 May;12(5):460-8. doi: 10.1016/S1470-2045(11)70069-9. Epub 2011 Apr 7.
- Results publication: 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.
- Results publication: PubMed 21940215Cabanillas F. Rituximab in DLBCL: 6 years on. Lancet Oncol. 2011 Oct;12(11):984-5. doi: 10.1016/S1470-2045(11)70251-0. Epub 2011 Sep 21. No abstract available.
- Results publication: PubMed 17400912Park S, Lee J, Ko YH, Han A, Jun HJ, Lee SC, Hwang IG, Park YH, Ahn JS, Jung CW, Kim K, Ahn YC, Kang WK, Park K, Kim WS. The impact of Epstein-Barr virus status on clinical outcome in diffuse large B-cell lymphoma. Blood. 2007 Aug 1;110(3):972-8. doi: 10.1182/blood-2007-01-067769. Epub 2007 Mar 30.
- Individual participant dataSharing planned: Yes
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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 Of Nanjing Medical University(JiangSu Province Hospital)
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rituximab, Gemcitabine and Oxaliplatin in people with Diffuse Large B Cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University at 6 sites 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 13 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 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Huayuan Zhu, M.D., Ph.D. (+86 68136034, huayuan.zhu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year overall survival rate (time frame: One year). 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 NCT02767674, which also lists 6 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 3 Jan 2019.