Lymphoma, Non-Hodgkin;Hodgkin DiseasePhase 4NCT02526823

Clinical Application of Polyethylene Glycol Liposome Doxorubicin (PLD) in Primary Lymphoma

A Phase 4 study testing R-CHOP/CHOPE or ABVD chemotherapy regimen and R-CDOP/CDOPE or DBVD chemotherapy regimen in people with Lymphoma, Non-Hodgkin;Hodgkin Disease, run by Shandong Provincial Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Lymphoma, Non-Hodgkin;Hodgkin Disease
What is being tested?: R-CHOP/CHOPE or ABVD chemotherapy regimen and R-CDOP/CDOPE or DBVD chemotherapy regimen
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 360 participants
Where: 1 siteChina
Study dates: Aug 2015to Dec 2019
Phase: Phase 4
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Primary B-NHL, PTCL (ALK+ anaplastic large cell lymphoma and NK(natural killer cell )/T cell lymphoma were excluded) or HL patients confirmed by histopathology;
Ages ≥18 years old, < 80 years old;
ECOG (Eastern Cooperative Oncology Group）score: 0-2
At least one measurable lesion;
Expected survival time≥3 months;
Liver function: transaminase≤2.5× upper limit of normal value，bilirubin≤1.5×upper limit of normal value;

Show all 10Show fewer

Renal function: serum creatinine is 44-133 mmol/L;
Routine blood test：WBC≥3.0×109/L，Neutrophils≥1.5×109/L，Hb≥100g/L，Platelet≥80×109/L； LVEF≥50%;
New York Heart Association (NYHA) heart function classification is I-II grade
signed informed consent.

Who cannot join

Patients with severe complications or severe infection;
Invasion of central nervous system;
Patients with severe heart disease history, including ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI), congestive heart failure (CHF), coronary heart disease patients needed therapy;
patients with severe allergic constitution, or those who are allergic to or intolerant of drug composition in chemotherapy regimens; with other malignant tumors in the past 5 years;
patients received doxorubicin therapy, total cumulative dose of adriamycin was more than 300 mg/m2, total cumulative dose of epirubicin was more than 450 mg/m2;
Patients participate in other clinical studies;
Other patients who are not suitable for the study.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

Department of Hematology, Provincial Hospital Affiliated to Shandong University
Jinan, Shandong, 250012
Xin Wang, MD, PHD, +86-531-68778331, xinw007@126.com
Lili Feng, MD, +86-531-68776358, fenglili1982624@163.com
Recruiting

Other trials in China

About this study

Anthracyclines were basic drugs in lymphoma treatment. However, their dose accumulation related cardiac toxicity limits their clinical application, especially adriamycin. Adriamycin has been gradually replaced by epirubicin. Polyethylene glycol liposome doxorubicin (PLD) can go into tumor tissues through tumor angiogenesis and produces targeted killing effect to tumor tissues. PLD has potential advantages in the treatment of malignant tumors,including lymphoma.

Read the detailed description

Lymphoma is one of the most rapidly growing malignant tumors in the world. It was divided into two major categories (Hodgkin's lymphoma (HL) and non Hodgkin's lymphoma (NHL). Anthracyclines were basic drugs in lymphoma treatment. However, their dose accumulation related cardiac toxicity limits their clinical application, especially adriamycin. Adriamycin has been gradually replaced by epirubicin in malignant tumor treatment because of its similar effects and less toxic side effects. Polyethylene glycol liposome doxorubicin (PLD) is the liposome formulation of doxorubicin. Methoxy Polyethylene Glycol (MPEG) contained in liposome surface can decrease the peak plasma levels of free drugs, extend drugs circulation time in blood and reduce the chance of non-specific distribution to normal tissues. PLD goes into tumor tissues through tumor angiogenesis and produces targeted killing effect to tumor tissues. PLD has potential advantages in the treatment of malignant tumors. In lymphoma patients' therapy, the clinical application of PLD is expected to be a new method. Therefore, the investigators designed the randomized controlled clinical study and aimed to compare the efficacy and safety between PLD and epirubicin in primary B-NHL, peripheral T-cell lymphoma (PTCL) and HL patients.

Conditions: Lymphoma, Non-Hodgkin;Hodgkin Disease
Being tested: R-CHOP/CHOPE or ABVD chemotherapy regimen, R-CDOP/CDOPE or DBVD chemotherapy regimen
Medical subject headings: Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

R-CHOP/CHOPE or ABVD chemotherapy regimenDrug
R-CHOP:
Rituximab：375mg/m2，ivgtt，D0； Epirubicin：70 mg/m2，ivgtt，D1 ； Cyclophosphamide：750 mg/m2，ivgtt，D1； Vincristine: 1.4 mg/m2 ivgtt，D1 ； Prednison：100mg/d，po，D1-5；
CHOPE:
Epirubicin：70 mg/m2，ivgtt，D1 ； Cyclophosphamide：750 mg/m2，ivgtt，D1； Vincristine: 1.4 mg/m2 ivgtt，D1 ； Prednison：100mg/d，po，D1-5； Etoposide: 100 mg/（m2•d），ivgtt，D1-3;
ABVD:
Epirubicin：35 mg/m2，ivgtt，D1、15； Bleomycin：10 mg/m2，ivgtt，D1、15； Vincristine：1.4 mg/m2，ivgtt，D1、15； Dacarbazine：375mg/m2，ivgtt，D1、15；
R-CDOP/CDOPE or DBVD chemotherapy regimenDrug
R-CDOP:
Rituximab：375mg/m2，ivgtt，D0； PLD 30-40 mg/m2，ivgtt，D1 ； Cyclophosphamide：750 mg/m2，ivgtt，D1； Vincristine: 1.4 mg/m2 ivgtt，D1 ； Prednison：100mg/d，po，D1-5；
CDOPE:
PLD 30-40 mg/m2，ivgtt，D1； Cyclophosphamide：750 mg/m2，ivgtt，D1； Vincristine: 1.4 mg/m2 ivgtt，D1 ； Prednison：100mg/d，po，D1-5； Etoposide: 100 mg/（m2•d），ivgtt，D1-3;
DBVD:
PLD 15-20 mg/m2，ivgtt，D1； Bleomycin：10 mg/m2，ivgtt，D1、15； Vincristine：1.4 mg/m2，ivgtt，D1、15； Dacarbazine：375mg/m2，ivgtt，D1、15；

Study groups in NCT02526823
Study group	Role	What they receive
R-CHOP/CHOPE or ABVD chemotherapy regimen	Active comparator	R-CHOP/CHOPE every 21 days or ABVD every 28 days for total 6 courses Receives: Drug: R-CHOP/CHOPE or ABVD chemotherapy regimen
R-CDOP/CDOPE or DBVD chemotherapy regimen	Experimental	R-CDOP/CDOPE every 21 days or DBVD every 28 days for total 6 courses Receives: Drug: R-CDOP/CDOPE or DBVD chemotherapy regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of patients with complete remission （CR）
Sum of products of greatest diameters （SPD）was used to evaluate the therapy effect.Number of participants with CR was assessed by Cheson Standard.
Measured: After two 21-day or 28-day courses, up to 42 to 56 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2015Dec 2019

First posted18 Aug 2015 (estimated)
Study startAug 2015
Primary completionDec 2019 (estimated)
Study completionDec 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Lymphoma, Non-Hodgkin;Hodgkin DiseaseStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 360 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02526823
Sponsor's protocol ID: ShandongPH01
Status last verified: Apr 2019
First submitted: 11 Aug 2015
Last updated: 2 Apr 2019
Results posted: No

Publications

Lotrionte M, Biondi-Zoccai G, Abbate A, Lanzetta G, D'Ascenzo F, Malavasi V, Peruzzi M, Frati G, Palazzoni G. Review and meta-analysis of incidence and clinical predictors of anthracycline cardiotoxicity. Am J Cardiol. 2013 Dec 15;112(12):1980-4. doi: 10.1016/j.amjcard.2013.08.026. Epub 2013 Sep 25.
PubMed 24075281
Italian Multicentre Breast Study with Epirubicin; Ambrosini G, Balli M, Garusi G, Demicheli R, Jirillo A, Bonciarelli G, Bruscagnin G, Fila G, Bumma C, Lacroix F, Buzzi F, Di Costanzo F, Padalino D, Brugia M, Calabresi F, Natali M, Cartei G, Chiesa G, Blasina B, Ciambellotti E, Moro G, D'Aquino S, Altavilla G, Adamo V, De Maria D, Falchi AM, Bertoncelli P, Farris A, Fiorentino M, Fornasiero A, Fosser V, Daniele O, Foggi CM, Speranza GB, Sartori S, Camilluzzi E, Gallo L, Poggio R, Secondo V, Gambi A, Grignani F, Capodicasa E, Lopez M, Papaldo P, Di Lauro L, Vici P, Marenco G, Folco U, Bonanni F, Marsilio P, Palazzotto G, Di Carlo A, Cusimano MP, Pastorino G, Puccetti C, Giusto M, Rausa L, Gebbia N, Palmeri S, D'Alessandro N, Saccani F, Becchi G, Schieppati G, Spinelli I, Tagliagambe A, Tonato M, Minotti V, Ardia A, Viaro D, De Micheli P, Zingali G, Sacchetti G, Intini C. Phase III randomized study of fluorouracil, epirubicin, and cyclophosphamide v fluorouracil, doxorubicin, and cyclophosphamide in advanced breast cancer: an Italian multicentre trial. J Clin Oncol. 1988 Jun;6(6):976-82. doi: 10.1200/JCO.1988.6.6.976.
PubMed 2897433
Bai B, Huang HQ, Cai QQ, Wang XX, Cai QC, Lin ZX, Gao Y, Xia Y, Bu Q, Guo Y. Promising long-term outcome of gemcitabine, vinorelbine, liposomal doxorubicin (GVD) in 14-day schedule as salvage regimen for patients with previously heavily treated Hodgkin's lymphoma and aggressive non-Hodgkin's lymphoma. Med Oncol. 2013 Mar;30(1):350. doi: 10.1007/s12032-012-0350-5. Epub 2013 Jan 18.
PubMed 23329307
Clozel T, Deau B, Benet C, Franchi P, Robin M, Madelaine I, Thieblemont C, de Kerviler E, Briere J, Brice P. Pegylated liposomal doxorubicin: an efficient treatment in patients with Hodgkin lymphoma relapsing after high dose therapy and stem cell transplation. Br J Haematol. 2013 Sep;162(6):846-8. doi: 10.1111/bjh.12428. Epub 2013 Jun 24. No abstract available.
PubMed 23789905
Schmitt CJ, Dietrich S, Ho AD, Witzens-Harig M. Replacement of conventional doxorubicin by pegylated liposomal doxorubicin is a safe and effective alternative in the treatment of non-Hodgkin's lymphoma patients with cardiac risk factors. Ann Hematol. 2012 Mar;91(3):391-7. doi: 10.1007/s00277-011-1308-y. Epub 2011 Aug 18.
PubMed 21850390
Fan Y, Lin NM, Luo LH, Fang L, Huang ZY, Yu HF, Wu FQ. Pharmacodynamic and pharmacokinetic study of pegylated liposomal doxorubicin combination (CCOP) chemotherapy in patients with peripheral T-cell lymphomas. Acta Pharmacol Sin. 2011 Mar;32(3):408-14. doi: 10.1038/aps.2010.217.
PubMed 21372831
Rafiyath SM, Rasul M, Lee B, Wei G, Lamba G, Liu D. Comparison of safety and toxicity of liposomal doxorubicin vs. conventional anthracyclines: a meta-analysis. Exp Hematol Oncol. 2012 Apr 23;1(1):10. doi: 10.1186/2162-3619-1-10.
PubMed 23210520

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Application of Polyethylene Glycol Liposome Doxorubicin (PLD) in Primary Lymphoma
ClinicalTrials.gov ID: NCT02526823
Acronym / sponsor ID: ShandongPH01
Conditions: Lymphoma, Non-Hodgkin;Hodgkin Disease
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 360 participants (estimated)
Lead sponsor: Shandong Provincial HospitalOther government
Study start: Aug 2015 (actual)
Primary completion: Dec 2019 (estimated)
Study completion: Dec 2019 (estimated)
First posted: 18 Aug 2015 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
R-CHOP/CHOPE or ABVD chemotherapy regimen	Active comparator	Drug: R-CHOP/CHOPE or ABVD chemotherapy regimenR-CHOP/CHOPE every 21 days or ABVD every 28 days for total 6 courses
R-CDOP/CDOPE or DBVD chemotherapy regimen	Experimental	Drug: R-CDOP/CDOPE or DBVD chemotherapy regimenR-CDOP/CDOPE every 21 days or DBVD every 28 days for total 6 courses

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Primary B-NHL, PTCL (ALK+ anaplastic large cell lymphoma and NK(natural killer cell )/T cell lymphoma were excluded) or HL patients confirmed by histopathology;
Ages ≥18 years old, < 80 years old;
ECOG (Eastern Cooperative Oncology Group）score: 0-2
At least one measurable lesion;
Expected survival time≥3 months;

Key exclusion criteria (7 listed)

Patients with severe complications or severe infection;
Invasion of central nervous system;
Patients with severe heart disease history, including ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI), congestive heart failure (CHF), coronary heart disease patients needed therapy;
patients with severe allergic constitution, or those who are allergic to or intolerant of drug composition in chemotherapy regimens; with other malignant tumors in the past 5 years;
patients received doxorubicin therapy, total cumulative dose of adriamycin was more than 300 mg/m2, total cumulative dose of epirubicin was more than 450 mg/m2;

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-CHOP/CHOPE or ABVD chemotherapy regimenR-CHOP: Rituximab：375mg/m2，ivgtt，D0； Epirubicin：70 mg/m2，ivgtt，D1 ； Cyclophosphamide：750 mg/m2，ivgtt，D1； Vincristine: 1.4 mg/m2 ivgtt，D1 ； Prednison：100mg/d，po，D1-5； CHOPE: Epirubicin：70 mg/m2，ivgtt，D1 ； Cyclophosphamide：750 mg/m2，ivgtt，D1； Vincristine: 1.4 mg/m2 ivgtt，D1 ； Prednison：100mg/d，po，D1-5； Etoposide: 100 mg/（m2•d），ivgtt，D1-3; ABVD: Epirubicin：35 mg/m2，ivgtt，D1、15； Bleomycin：10 mg/m2，ivgtt，D1、15； Vincristine：1.4 mg/m2，ivgtt，D1、15； Dacarbazine：375mg/m2，ivgtt，D1、15；	Drug	R-CHOP/CHOPE or ABVD chemotherapy regimen
R-CDOP/CDOPE or DBVD chemotherapy regimenR-CDOP: Rituximab：375mg/m2，ivgtt，D0； PLD 30-40 mg/m2，ivgtt，D1 ； Cyclophosphamide：750 mg/m2，ivgtt，D1； Vincristine: 1.4 mg/m2 ivgtt，D1 ； Prednison：100mg/d，po，D1-5； CDOPE: PLD 30-40 mg/m2，ivgtt，D1； Cyclophosphamide：750 mg/m2，ivgtt，D1； Vincristine: 1.4 mg/m2 ivgtt，D1 ； Prednison：100mg/d，po，D1-5； Etoposide: 100 mg/（m2•d），ivgtt，D1-3; DBVD: PLD 15-20 mg/m2，ivgtt，D1； Bleomycin：10 mg/m2，ivgtt，D1、15； Vincristine：1.4 mg/m2，ivgtt，D1、15； Dacarbazine：375mg/m2，ivgtt，D1、15；	Drug	R-CDOP/CDOPE or DBVD chemotherapy regimen

Primary outcome

Percentage of patients with complete remission （CR）
Time frame: After two 21-day or 28-day courses, up to 42 to 56 days.
Sum of products of greatest diameters （SPD）was used to evaluate the therapy effect.Number of participants with CR was assessed by Cheson Standard.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
Background: PubMed 24075281Lotrionte M, Biondi-Zoccai G, Abbate A, Lanzetta G, D'Ascenzo F, Malavasi V, Peruzzi M, Frati G, Palazzoni G. Review and meta-analysis of incidence and clinical predictors of anthracycline cardiotoxicity. Am J Cardiol. 2013 Dec 15;112(12):1980-4. doi: 10.1016/j.amjcard.2013.08.026. Epub 2013 Sep 25.
Background: PubMed 2897433Italian Multicentre Breast Study with Epirubicin; Ambrosini G, Balli M, Garusi G, Demicheli R, Jirillo A, Bonciarelli G, Bruscagnin G, Fila G, Bumma C, Lacroix F, Buzzi F, Di Costanzo F, Padalino D, Brugia M, Calabresi F, Natali M, Cartei G, Chiesa G, Blasina B, Ciambellotti E, Moro G, D'Aquino S, Altavilla G, Adamo V, De Maria D, Falchi AM, Bertoncelli P, Farris A, Fiorentino M, Fornasiero A, Fosser V, Daniele O, Foggi CM, Speranza GB, Sartori S, Camilluzzi E, Gallo L, Poggio R, Secondo V, Gambi A, Grignani F, Capodicasa E, Lopez M, Papaldo P, Di Lauro L, Vici P, Marenco G, Folco U, Bonanni F, Marsilio P, Palazzotto G, Di Carlo A, Cusimano MP, Pastorino G, Puccetti C, Giusto M, Rausa L, Gebbia N, Palmeri S, D'Alessandro N, Saccani F, Becchi G, Schieppati G, Spinelli I, Tagliagambe A, Tonato M, Minotti V, Ardia A, Viaro D, De Micheli P, Zingali G, Sacchetti G, Intini C. Phase III randomized study of fluorouracil, epirubicin, and cyclophosphamide v fluorouracil, doxorubicin, and cyclophosphamide in advanced breast cancer: an Italian multicentre trial. J Clin Oncol. 1988 Jun;6(6):976-82. doi: 10.1200/JCO.1988.6.6.976.
Background: PubMed 23329307Bai B, Huang HQ, Cai QQ, Wang XX, Cai QC, Lin ZX, Gao Y, Xia Y, Bu Q, Guo Y. Promising long-term outcome of gemcitabine, vinorelbine, liposomal doxorubicin (GVD) in 14-day schedule as salvage regimen for patients with previously heavily treated Hodgkin's lymphoma and aggressive non-Hodgkin's lymphoma. Med Oncol. 2013 Mar;30(1):350. doi: 10.1007/s12032-012-0350-5. Epub 2013 Jan 18.
Background: PubMed 23789905Clozel T, Deau B, Benet C, Franchi P, Robin M, Madelaine I, Thieblemont C, de Kerviler E, Briere J, Brice P. Pegylated liposomal doxorubicin: an efficient treatment in patients with Hodgkin lymphoma relapsing after high dose therapy and stem cell transplation. Br J Haematol. 2013 Sep;162(6):846-8. doi: 10.1111/bjh.12428. Epub 2013 Jun 24. No abstract available.
Background: PubMed 21850390Schmitt CJ, Dietrich S, Ho AD, Witzens-Harig M. Replacement of conventional doxorubicin by pegylated liposomal doxorubicin is a safe and effective alternative in the treatment of non-Hodgkin's lymphoma patients with cardiac risk factors. Ann Hematol. 2012 Mar;91(3):391-7. doi: 10.1007/s00277-011-1308-y. Epub 2011 Aug 18.
Background: PubMed 21372831Fan Y, Lin NM, Luo LH, Fang L, Huang ZY, Yu HF, Wu FQ. Pharmacodynamic and pharmacokinetic study of pegylated liposomal doxorubicin combination (CCOP) chemotherapy in patients with peripheral T-cell lymphomas. Acta Pharmacol Sin. 2011 Mar;32(3):408-14. doi: 10.1038/aps.2010.217.
Background: PubMed 23210520Rafiyath SM, Rasul M, Lee B, Wei G, Lamba G, Liu D. Comparison of safety and toxicity of liposomal doxorubicin vs. conventional anthracyclines: a meta-analysis. Exp Hematol Oncol. 2012 Apr 23;1(1):10. doi: 10.1186/2162-3619-1-10.

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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.

Department of Hematology, Provincial Hospital Affiliated to Shandong University

Jinan, China

+86-531-68778331

xinw007@126.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 7 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 2 Apr 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with complete remission （CR） (time frame: After two 21-day or 28-day courses, up to 42 to 56 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 NCT02526823, which also lists 7 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 2 Apr 2019.