Diffuse, Large B-Cell, LymphomaPhase 2/3NCT02871869
Cinobufacini Tablets Combined With Chemotherapeutic Protocol in Treatment of Diffuse Large B Cell Lymphoma
A Phase 2/3 study testing vindesine, cyclophosphamide and Epirubicin in people with Diffuse, Large B-Cell, Lymphoma, run by Xinjiang Medical University at 1 site in China.
Trial summary
Diffuse large B cell lymphoma (DLBCL), as the most common subtype non-Hodgkin lymphoma (NHL), has great heterogeneity in clinical manifestations, histological morphology and prognosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diffuse, Large B-Cell, Lymphoma
- What is being tested?
- vindesine, cyclophosphamide and Epirubicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Dec 2021
- Phase
- Phase 2/3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-70 years old;
- Patients with eastern Collaborative Oncology Group (ECOG) performance status (PS) score: 0～3 points;
- International prognostic index (IPI): ≤3 points;
- Patients who were diagnosed as diffuse large B cell lymphoma (DLBCL) with initial treatment by histopathology;
- Patients with more than 1 measurable nidus (common CT or MRI scanning diameter ≥ 20 mm, and spiral CT scanning diameter ≥ 10 mm);
- Patients without dysfunction of important organs, and had normal blood routine, hepatorenal function and cardiac function. White blood cell count (WBC) ≥4.0×109/L, neutrophil count ≥1.5×109/L; platelet (PLT) count ≥100×109/L; hemoglobin (HGB) ≥95g/L; serum bilirubin (Bil) ≤1.5 folds of the upper limit of normal value, alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤2 folds of the upper limit of normal value, and serum creatinine (Scr) ≤1.5mg/dl;
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- Patients with expected survival time>3 months;
- Patients who were well informed of this study and signed the informed consent forms.
- Patients who received administration of Rituximab.
- Patients aged 18-70 years old;
- Patients with eastern Collaborative Oncology Group (ECOG) performance status (PS) score: 0～3 points;
- International prognostic index (IPI): ≤3 points;
- Patients who were diagnosed as diffuse large B cell lymphoma (DLBCL) with initial treatment by histopathology;
- Patients with more than 1 measurable nidus (common CT or MRI scanning diameter ≥ 20 mm, and spiral CT scanning diameter ≥ 10 mm);
- Patients without dysfunction of important organs, and had normal blood routine, hepatorenal function and cardiac function. White blood cell count (WBC) ≥4.0×109/L, neutrophil count ≥1.5×109/L; platelet (PLT) count ≥100×109/L; hemoglobin (HGB) ≥95g/L; serum bilirubin (Bil) ≤1.5 folds of the upper limit of normal value, alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤2 folds of the upper limit of normal value, and serum creatinine (Scr) ≤1.5mg/dl;
- Patients with expected survival time>3 months;
- Patients who were well informed of this study and signed the informed consent forms.
- Patients who did not receive administration of Rituximab.
Who cannot join
- Patients who did not conform to above criteria;
- Patients who were receiving other anti-cancer therapies;
- Patients with DLBCL affected by primary breast gland, lung, testis, bone, peri-orbit, peri-spine, central nerve system and bone marrow;
- Patients with double expression, double strike, trinary expression and trinary strike and CD5+;
- Patients complicated with other non-DLBCL primary malignant tumors;
- Patients who had poor compliance with their families;
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- Patients with one of the following conditions: uncontrolled metastatic nidi of central nerve system, dysfunction of important organs and severe cardiac diseases like congestive heart failure, uncontrollable arrhythmia, angina pectoris that needed long-term drug administration, valvular heart diseases, myocardial infarction and refractory hypertension, pregnancy or lactation, chronic infectious wounds, and history of uncontrollable psychological diseases.
- Patients had previous history of treatment with Cinobufacini Tablets.
- For control and trial groups B
- Patients who did not conform to above criteria;
- Patients who were receiving other anti-cancer therapies;
- Patients with DLBCL affected by primary breast gland, lung, testis, bone, peri-orbit, peri-spine, central nerve system and bone marrow;
- Patients with double expression, double strike, trinary expression and trinary strike and CD5+;
- Patients complicated with other non-DLBCL primary malignant tumors;
- Patients who had poor compliance with their families;
- Patients with one of the following conditions: uncontrolled metastatic nidi of central nerve system, dysfunction of important organs and severe cardiac diseases like congestive heart failure, uncontrollable arrhythmia, angina pectoris that needed long-term drug administration, valvular heart diseases, myocardial infarction and refractory hypertension, pregnancy or lactation, chronic infectious wounds, and history of uncontrollable psychological diseases.
- Patients had previous history of treatment with Cinobufacini Tablets.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Affiliated to Xinjiang Medical University
Ürümqi, Xinjiang, 830011
Shun-E Yang, Professor, 13669926688, yangshune@medmail.com.cn
About this study
Official title: Cinobufacini Tablets Combined With R-CHOP Protocol (Rituximab + Vindesine + Cyclophosphamide + Epirubicin + Prednisone)/CHOP in Treatment of Diffuse Large B Cell Lymphoma: A Phase II Randomized, Controlled and Multi-center Study
Diffuse large B cell lymphoma (DLBCL), as the most common subtype non-Hodgkin lymphoma (NHL), has great heterogeneity in clinical manifestations, histological morphology and prognosis. R-CHOP Protocol (Rituximab + Vindesine + Cyclophosphamide + Epirubicin + Prednisone) is the gold therapeutic criteria for patients with NHL, and it is also used as the first-line treatment for patients with DLBCL. After treatment, 50％～60％of patients with DLBCL receive complete remission (CR), 30％～40％ recurrent and 10% will never be cured due to initial and secondary drug tolerance. This study aimed to explore whether Cinobufacini Tablets had synergistic effect in the treatment of DLBCL, and whether its action was in close association with the positive expression of Na+/K+-ATPase α3, and to observe the rates of adverse reactions induced by Cinobufacini Tablets during treatment.
Read the detailed description
Diffuse large B cell lymphoma (DLBCL), as the most common subtype non-Hodgkin lymphoma (NHL), accounts for 30％～40％ of adults with NHL, and has great heterogeneity in clinical manifestations, histological morphology and prognosis. R-CHOP Protocol (Rituximab + Vindesine + Cyclophosphamide + Epirubicin + Prednisone) is the gold therapeutic criteria for patients with NHL, and it is also used as the first-line treatment for patients with DLBCL. After treatment, 50％～60％of patients with DLBCL receive complete remission (CR), 30％～40％ recurrent and 10% will never be cured due to initial and secondary drug tolerance. The study of Tao Wu et al in domestic showed that cinobufacini combined with CHOP protocol had excellent efficacy in the treatment of NHL, with response rate reaching up to 91.7%, and the adverse reactions were mild and tolerable, whereas the response rate of single CHOP was only 62.5%. In the clinical practice of our studies, it was also found that some patients with recurrent DLBCL NHL also had shrunken or disappeared tumors and a survival time of more than 2 years after single administration of cinobufacini tablets for 3~6 months following the withdrawal of chemotherapy. This study aimed to explore whether Cinobufacini Tablets had synergistic effect in the treatment of DLBCL, and whether its action was in close association with the positive expression of Na+/K+-ATPase α3, and to observe the rates of adverse reactions induced by Cinobufacini Tablets during treatment.
- Conditions
- Diffuse, Large B-Cell, Lymphoma
- Being tested
- vindesine, cyclophosphamide, Epirubicin, prednisone tablets, Cinobufacini Tablets
- Keywords
- Cinobufacini Tablets, CHOP protocol
- 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.
vindesineDrug
Also called eldisine
3 mg/㎡ (maximum dosage: <4mg), d1, 21 d as a cycle, for 4～6 cycles
cyclophosphamideDrug
Also called endoxan
750 mg/㎡, d1, 21 d as a cycle, for 4～6 cycles
EpirubicinDrug
Also called EPI
60 mg/㎡, d1, 21 d as a cycle, for 4～6 cycles
prednisone tabletsDrug
Also called metacortandracin
100 mg, d1～5, 21 d as a cycle, for 4～6 cycles
Cinobufacini TabletsDrug
Also called buformin
0.3 g per tablet, 3 tablets per time, tid., p.o., until progressive disease or intolerable drug toxicities
RituximabDrug
Also called RTX
375mg/㎡,one day before CHOP protocol
| Study group | Role | What they receive |
|---|---|---|
| Control group A | Active comparator | Control group A was treated with single R-CHOP protocol[Rituximab 375mg/㎡,one day before CHOP protocol, CHOP protocol included vindesine 3 mg/㎡ (maximum dosage: <4mg) d1 plus cyclophosphamide 750 mg/㎡ d1 plus Epirubicin 60 mg/㎡ d1 plus prednisone tablets 100 mg, d1～5], 21 d as a cycle, for 4～6 cycles. Receives: Drug: vindesine; Drug: cyclophosphamide; Drug: Epirubicin; Drug: prednisone tablets; Drug: Rituximab |
| Trial group A | Experimental | Trial group A was treated with Cinobufacini Tablets combined with R-CHOP protocol[Rituximab 375mg/㎡,one day before CHOP protocol, CHOP protocol included vindesine 3 mg/㎡ (maximum dosage: <4mg) d1 plus cyclophosphamide 750 mg/㎡ d1 plus Epirubicin 60 mg/㎡d1 plus prednisone tablets 100 mg, d1～5], 21 d as a cycle, for 4～6 cycles. Receives: Drug: vindesine; Drug: cyclophosphamide; Drug: Epirubicin; Drug: prednisone tablets; Drug: Cinobufacini Tablets; Drug: Rituximab |
| Control group B | Active comparator | Control group B was treated with single CHOP protocol[vindesine 3 mg/㎡ (maximum dosage: <4mg) d1 plus cyclophosphamide 750 mg/㎡ d1 plus Epirubicin 60 mg/㎡ d1 plus prednisone tablets 100 mg, d1～5], 21 d as a cycle, for 4～6 cycles. Receives: Drug: vindesine; Drug: cyclophosphamide; Drug: Epirubicin; Drug: prednisone tablets |
| Trial group B | Experimental | Trial group B was treated with Cinobufacini Tablets combined with CHOP protocol[vindesine 3 mg/㎡ (maximum dosage: <4mg) d1 plus cyclophosphamide 750 mg/㎡ d1 plus Epirubicin 60 mg/㎡ d1 plus prednisone tablets 100 mg, d1～5], 21 d as a cycle, for 4～6 cycles. Receives: Drug: vindesine; Drug: cyclophosphamide; Drug: Epirubicin; Drug: prednisone tablets; Drug: Cinobufacini Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
3-year Progression-free survival (PFS) defined as the ratio of study subjects who had disease progression or died within 3 years from the start of randomization.
Measured: 3 years
Secondary outcomes (4)
Overall response rate (ORR)
Overall response rate (ORR) that defined as the total ratio of study subjects with complete response, complete response unconfirmed and partial response after treatment. ORR=(CR+ CRu+ PR)cases/total cases×100%.
Measured: 2 years
overall survival rate (OS)
3-year overall survival rate (OS) that defined as the ratio of study subjects who survived 3 years after randomization
Measured: 3 years
Safety and Tolerability
Incidence of Treatment-Emergent adverse events
Measured: 2 years
Relationship between synergistic effect of Cinobufacini Tablets and expression of Na+/K+-ATPase α3
Relationship between synergistic effect of Cinobufacini Tablets and expression of Na+/K+-ATPase α3
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2018 (estimated)
- Study completionDec 2021 (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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinjiang Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shun-E Yang, Xinjiang Medical University
- Investigators
- Shun-E Yang, Professor, Study chair, Cancer Hospital Affiliated to Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871869
- Sponsor's protocol ID
- XinjiangMU2016(015)V2.0
- Status last verified
- Jul 2017
- First submitted
- 12 Aug 2016
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cinobufacini Tablets Combined With R-CHOP Protocol (Rituximab + Vindesine + Cyclophosphamide + Epirubicin + Prednisone)/CHOP in Treatment of Diffuse Large B Cell Lymphoma: A Phase II Randomized, Controlled and Multi-center Study
- ClinicalTrials.gov ID
- NCT02871869
- Acronym / sponsor ID
- XinjiangMU2016(015)V2.0
- Conditions
- Diffuse, Large B-Cell, Lymphoma
- Keywords
- Cinobufacini Tablets, CHOP protocol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Xinjiang Medical UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 18 Aug 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.
Diffuse large B cell lymphoma (DLBCL), as the most common subtype non-Hodgkin lymphoma (NHL), has great heterogeneity in clinical manifestations, histological morphology and prognosis. R-CHOP Protocol (Rituximab + Vindesine + Cyclophosphamide + Epirubicin + Prednisone) is the gold therapeutic criteria for patients with NHL, and it is also used as the first-line treatment for patients with DLBCL. After treatment, 50％～60％of patients with DLBCL receive complete remission (CR), 30％～40％ recurrent and 10% will never be cured due to initial and secondary drug tolerance. This study aimed to explore whether Cinobufacini Tablets had synergistic effect in the treatment of DLBCL, and whether its action was in close association with the positive expression of Na+/K+-ATPase α3, and to observe the rates of adverse reactions induced by Cinobufacini Tablets during treatment.
Detailed description
Diffuse large B cell lymphoma (DLBCL), as the most common subtype non-Hodgkin lymphoma (NHL), accounts for 30％～40％ of adults with NHL, and has great heterogeneity in clinical manifestations, histological morphology and prognosis. R-CHOP Protocol (Rituximab + Vindesine + Cyclophosphamide + Epirubicin + Prednisone) is the gold therapeutic criteria for patients with NHL, and it is also used as the first-line treatment for patients with DLBCL. After treatment, 50％～60％of patients with DLBCL receive complete remission (CR), 30％～40％ recurrent and 10% will never be cured due to initial and secondary drug tolerance. The study of Tao Wu et al in domestic showed that cinobufacini combined with CHOP protocol had excellent efficacy in the treatment of NHL, with response rate reaching up to 91.7%, and the adverse reactions were mild and tolerable, whereas the response rate of single CHOP was only 62.5%. In the clinical practice of our studies, it was also found that some patients with recurrent DLBCL NHL also had shrunken or disappeared tumors and a survival time of more than 2 years after single administration of cinobufacini tablets for 3~6 months following the withdrawal of chemotherapy. This study aimed to explore whether Cinobufacini Tablets had synergistic effect in the treatment of DLBCL, and whether its action was in close association with the positive expression of Na+/K+-ATPase α3, and to observe the rates of adverse reactions induced by Cinobufacini Tablets during treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group A | Active comparator | Drug: vindesine, Drug: cyclophosphamide, Drug: Epirubicin, Drug: prednisone tablets, Drug: RituximabControl group A was treated with single R-CHOP protocol[Rituximab 375mg/㎡,one day before CHOP protocol, CHOP protocol included vindesine 3 mg/㎡ (maximum dosage: <4mg) d1 plus cyclophosphamide 750 mg/㎡ d1 plus Epirubicin 60 mg/㎡ d1 plus prednisone tablets 100 mg, d1～5], 21 d as a cycle, for 4～6 cycles. |
| Trial group A | Experimental | Drug: vindesine, Drug: cyclophosphamide, Drug: Epirubicin, Drug: prednisone tablets, Drug: Cinobufacini Tablets, Drug: RituximabTrial group A was treated with Cinobufacini Tablets combined with R-CHOP protocol[Rituximab 375mg/㎡,one day before CHOP protocol, CHOP protocol included vindesine 3 mg/㎡ (maximum dosage: <4mg) d1 plus cyclophosphamide 750 mg/㎡ d1 plus Epirubicin 60 mg/㎡d1 plus prednisone tablets 100 mg, d1～5], 21 d as a cycle, for 4～6 cycles. |
| Control group B | Active comparator | Drug: vindesine, Drug: cyclophosphamide, Drug: Epirubicin, Drug: prednisone tabletsControl group B was treated with single CHOP protocol[vindesine 3 mg/㎡ (maximum dosage: <4mg) d1 plus cyclophosphamide 750 mg/㎡ d1 plus Epirubicin 60 mg/㎡ d1 plus prednisone tablets 100 mg, d1～5], 21 d as a cycle, for 4～6 cycles. |
| Trial group B | Experimental | Drug: vindesine, Drug: cyclophosphamide, Drug: Epirubicin, Drug: prednisone tablets, Drug: Cinobufacini TabletsTrial group B was treated with Cinobufacini Tablets combined with CHOP protocol[vindesine 3 mg/㎡ (maximum dosage: <4mg) d1 plus cyclophosphamide 750 mg/㎡ d1 plus Epirubicin 60 mg/㎡ d1 plus prednisone tablets 100 mg, d1～5], 21 d as a cycle, for 4～6 cycles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients aged 18-70 years old;
- Patients with eastern Collaborative Oncology Group (ECOG) performance status (PS) score: 0～3 points;
- International prognostic index (IPI): ≤3 points;
- Patients who were diagnosed as diffuse large B cell lymphoma (DLBCL) with initial treatment by histopathology;
- Patients with more than 1 measurable nidus (common CT or MRI scanning diameter ≥ 20 mm, and spiral CT scanning diameter ≥ 10 mm);
Key exclusion criteria (17 listed)
- Patients who did not conform to above criteria;
- Patients who were receiving other anti-cancer therapies;
- Patients with DLBCL affected by primary breast gland, lung, testis, bone, peri-orbit, peri-spine, central nerve system and bone marrow;
- Patients with double expression, double strike, trinary expression and trinary strike and CD5+;
- Patients complicated with other non-DLBCL primary malignant tumors;
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 |
|---|---|---|
| vindesineAlso: eldisine3 mg/㎡ (maximum dosage: <4mg), d1, 21 d as a cycle, for 4～6 cycles | Drug | Control group A, Control group B, Trial group A, Trial group B |
| cyclophosphamideAlso: endoxan750 mg/㎡, d1, 21 d as a cycle, for 4～6 cycles | Drug | Control group A, Control group B, Trial group A, Trial group B |
| EpirubicinAlso: EPI60 mg/㎡, d1, 21 d as a cycle, for 4～6 cycles | Drug | Control group A, Control group B, Trial group A, Trial group B |
| prednisone tabletsAlso: metacortandracin100 mg, d1～5, 21 d as a cycle, for 4～6 cycles | Drug | Control group A, Control group B, Trial group A, Trial group B |
| Cinobufacini TabletsAlso: buformin0.3 g per tablet, 3 tablets per time, tid., p.o., until progressive disease or intolerable drug toxicities | Drug | Trial group A, Trial group B |
| RituximabAlso: RTX375mg/㎡,one day before CHOP protocol | Drug | Control group A, Trial group A |
Primary outcome
Progression-free survival (PFS)
Time frame: 3 years
3-year Progression-free survival (PFS) defined as the ratio of study subjects who had disease progression or died within 3 years from the start of randomization.
4 secondary outcomes
Overall response rate (ORR)
Time frame: 2 years
overall survival rate (OS)
Time frame: 3 years
Safety and Tolerability
Time frame: 2 years
Relationship between synergistic effect of Cinobufacini Tablets and expression of Na+/K+-ATPase α3
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Shun-E Yang, Professor study chair
Cancer Hospital Affiliated to Xinjiang Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing vindesine, cyclophosphamide and Epirubicin in people with Diffuse, Large B-Cell, Lymphoma, run by Xinjiang Medical 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 18 inclusion and 17 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 17 Jul 2017. 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 combined 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.
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 Shun-E Yang, Professor (13669926688, yangshune@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 3 years). 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 17 Jul 2017.