Relapsed/Refractory Non-Hodgkin's LymphomaPhase 4NCT04134247
Study of PD-1 Monoclonal Antibody in Combination With Chemotherapy in Patients With RR NHL
A Phase 4 study testing PD-1 combined with chemotherapy and chemotherapy in people with Relapsed/Refractory Non-Hodgkin's Lymphoma, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
Lymphoma is one of the fastest growing malignancies in the world, with an annual incidence rate of about 4%. Non-Hodgkin's lymphoma (NHL) is highly heterogeneous and can be broadly divided into two major categories, B-cell lymphoma and T/NK cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Non-Hodgkin's Lymphoma
- What is being tested?
- PD-1 combined with chemotherapy and chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 1 Nov 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-Hodgkin's lymphoma (NHL) confirmed by histopathology, preferably in the detection of tumor tissue PD-L1 expression.
- A recurrent or refractory disease defined as: 1) recurrence of disease after complete remission (CR); or 2) partial remission (PR), disease stabilization (SD), or disease Progress (PD) when the treatment is completed prior to enrollment in the study.
- Age≥18 years old, both men and women.
- The ECOG score is 0-2.
- There is at least one evaluable lesion (maximum diameter>15mm or shortest diameter>10mm). Preferably, PET-CT shows high metabolism of FDG.
- Have received appropriate first-line and more-line treatment of the corresponding NHL.
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- Liver and kidney function: blood bilirubin≤35μmol/L, AST or ALT is less than 2 times the upper limit of normal value, serum creatinine≤150μmol/L.
- The thyroid function is normal.
- Women of childbearing age are required to undergo a pregnancy test before receiving treatment and must agree to take effective contraception during treatment.
- Subjects must sign an informed consent form.
Who cannot join
- Age<18 years old；
- Received ASCT within 90 days prior to the first use of the study drug;
- Severe allergies, or patients known to be allergic or intolerant of the drug components of the chemotherapy regimen;
- Active, unrecognized or suspected autoimmune disease, or a history of autoimmune disease within 2 years;
- Previously exposed to any antibody against PD-1, PD-L1 or cytotoxic T lymphocyte-associated antigen 4
- Exposure to any study drug within 4 weeks prior to the first use of the study drug
Show all 14Show fewer
- Expose to the last radiotherapy or anti-tumor therapy (chemotherapy, targeted therapy, immunotherapy or arterial embolization) within 3 weeks prior to the first use of the study drug.
- Have a history of oncology and have received any treatment for this tumor in the past 3 years;
- Patients during pregnancy and lactation;
- Accompanied by severe heart disease, including acute myocardial infarction within 6 months, or in accordance with New York Heart Association cardiac function III or IV;
- A serological test for HIV or active hepatitis C virus is known to be positive;
- Hepatitis B virus carriers or hepatitis B virus DNA positive untreated patients are known;
- TB patients active period
- Other circumstances that the investigator believes are not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Hematology, Shandong Provincial Hospital
Jinan, Shandong, 250012
Wang Xin, MD, PHD, +86-531-68778331, xinw8331@163.com
Ge Xueling, MD, +86-531-68778331, xueling0617@126.com
About this study
Official title: Study of PD-1 Monoclonal Antibody in Combination With Chemotherapy in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
Lymphoma is one of the fastest growing malignancies in the world, with an annual incidence rate of about 4%. Non-Hodgkin's lymphoma (NHL) is highly heterogeneous and can be broadly divided into two major categories, B-cell lymphoma and T/NK cell lymphoma. It is composed of diseases of different pathological types and malignant degrees, and the prognosis is not the same.The anti-PD-1 antibody may benefit patients with relapsed or refractory Hodgkin's lymphoma. At the same time, in non-Hodgkin's lymphoma, PD1 antibodies also show promising therapeutic prospects. We propose this research program, based on the previous research at home and abroad, to further clarify the role of PD-1 monoclonal antibody combined with chemotherapy in the treatment of relapsed and refractory NHL patients, evaluate its clinical efficacy and safety, and explore The best treatment strategy for patients with relapsed and refractory NHL in China.
Read the detailed description
Lymphoma is one of the fastest growing malignancies in the world, with an annual incidence rate of about 4%. In recent years, the incidence of malignant lymphoma in China has increased rapidly. It has risen to the ninth place among the top ten high-incidence tumors in men, and the female has risen to the eleventh place. In 2011, the incidence of lymphoma in the country has reached 6.43/100,000.
According to the characteristics of clinicopathology, lymphoma is divided into two categories: Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL). HL is a single disease, relatively rare, but the prognosis is good, and patients with limited period have no progress for 5 years. The survival rate was 85-95%, and the 5-year progression-free survival rate of advanced patients was 30-85%. NHL is highly heterogeneous and can be broadly divided into two major categories, B-cell lymphoma and T/NK cell lymphoma. It is composed of diseases of different pathological types and malignant degrees, and the prognosis is not the same.
In recent years, immunological checkpoint inhibitors have been the focus of research in the field of malignant tumor treatment. In clinical trials, PD-1/PD-L1 was found to be abnormally expressed in various lymphomas, including T-cell lymphoma, mediastinal large B-cell lymphoma, classical Hodgkin's lymphoma (CHL), and large variability. Cell lymphoma. Previous studies have evaluated the effects of antibody-based drugs against PD-1 (such as navobizumab and pabuleizumab) in patients with relapsed or refractory classic Hodgkin's lymphoma, and A higher response rate is shown and the security feature is acceptable. The domestic ORIENT-1 study showed that ididilimumab was highly active in patients with relapsed or refractory classic Hodgkin's lymphoma in China, and 80% (74/92) patients had an objective response. No patients died during the study. Of the 96 patients treated, 89 (93%) had treatment-related adverse events, including 17 (18%) patients with grade 3 or 4 treatment-related adverse events, and 11 patients (11%) experienced severe Adverse events, but no unexpected or off-target safety signals were found. Therefore, PD1 antibodies may benefit patients with relapsed or refractory Hodgkin's lymphoma.
At the same time, in non-Hodgkin's lymphoma, PD1 antibodies also show promising therapeutic prospects. Clinical studies at home and abroad have shown that PD-1 inhibitors are effective in relapsed or refractory extranodal NKT lymphoma. The results of the Idiliumab ORIENT-4 test showed that 1 year OS 82.1%, ORR 67.9%, DCR 85.7%, and PD-1 inhibitor combined with citabin to treat relapsed or refractory extranodal NKT is underway; PD-1 inhibitor monotherapy for relapsed or refractory PTCL is generally effective (ORR 33%, 4 of them CR); PD-1 inhibitor monotherapy is effective in treating relapsed or refractory mycosis/Sezary syndrome (ORR) 37.5%) has been recommended by the NCCN guidelines; trials in combination with IFN γ-1b are underway. PD-1 inhibitor monotherapy for relapsed or refractory PMBCL or PCNSL is effective, and PD-1 inhibitors have been recommended by the NCCN guidelines for the former treatment.
Therefore, we propose this research program, based on the previous research at home and abroad, to further clarify the role of PD-1 monoclonal antibody combined with chemotherapy in the treatment of relapsed and refractory NHL patients, evaluate its clinical efficacy and safety, and explore The best treatment strategy for patients with relapsed and refractory NHL in China.
- Being tested
- PD-1 combined with chemotherapy, chemotherapy
- 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.
PD-1 combined with chemotherapyDrug
Also called PD-1 combined with chemotherapy group
PD-1 200 mg，d1; Rituximab 375mg/m2，d0（ the same as the chemotherapy group）
The chemotherapy chooses one of the following:
GDP：Gemcitabine 800-1000mg/m2, d1、8; Cisplatin 25mg/m2, d1-3; Dexamethasone 40mg, d1-4; GemOx：Gemcitabine 800-1000mg/m2, d1、8; Oxaliplatin 130mg/m2，d1; DA-EPOCH：Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5; ICE: Ifosfamide 1g/m２，d1-4; Cisplatin 25mg/m２, d1-4; Etoposide 60 mg／m２，d1-4; DICE: Ifosfamide 1 g／m２，dl-d4; Cisplatin 25mg/m２, d1-4; Etoposide 60 mg／m２，d1-4; Dexamethasone 10-20mg，d1-4; High dose MTX（Central recurrence）：MTX 3.5g／ｍ２,ｄ1; Hyper CVAD（B）：MTX 1g／ｍ２, d1; Cytarabine 2-3g／ｍ２, q12h, d2-3
chemotherapyDrug
Also called chemotherapy group
Rituximab 375mg/m2，d0（ Except for patients who relapsed within12 months after the last application of rituximab）
The chemotherapy chooses one of the following:
GDP：Gemcitabine 800-1000mg/m2, d1、8; Cisplatin 25mg/m2, d1-3; Dexamethasone 40mg, d1-4; GemOx：Gemcitabine 800-1000mg/m2, d1、8; Oxaliplatin 130mg/m2，d1; DA-EPOCH：Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5; ICE: Ifosfamide 1g/m２，d1-4; Cisplatin 25mg/m２, d1-4; Etoposide 60 mg／m２，d1-4; DICE: Ifosfamide 1 g／m２，dl-d4; Cisplatin 25mg/m２, d1-4; Etoposide 60 mg／m２，d1-4; Dexamethasone 10-20mg，d1-4; High dose MTX（Central recurrence）：MTX 3.5g／ｍ２,ｄ1; Hyper CVAD（B）：MTX 1g／ｍ２, d1; Cytarabine 2-3g／ｍ２, q12h, d2-3
| Study group | Role | What they receive |
|---|---|---|
| PD-1 combined with chemotherapy | Experimental | 21 days every cycle, assessment after 3-cycle Receives: Drug: PD-1 combined with chemotherapy |
| chemotherapy | Active comparator | 21 days every cycle, assessment after 3-cycle Receives: Drug: chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Percentage of patients with complete remission （CR）or partial remission （PR）
Measured: 2 years
Secondary outcomes (2)
Progression free survival（PFS）
Time from enrollment to tumor progression or death
Measured: 2 years
overall survival（OS）
Time from enrollment to death
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 posted22 Oct 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Non-Hodgkin's 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wang Xin, Shandong Provincial Hospital
- Investigators
- Wang Xin, MD,PhD, Principal investigator, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134247
- Sponsor's protocol ID
- ShandongPH006
- Status last verified
- Oct 2019
- First submitted
- 18 Oct 2019
- Last updated
- 22 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of PD-1 Monoclonal Antibody in Combination With Chemotherapy in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT04134247
- Acronym / sponsor ID
- ShandongPH006
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 22 Oct 2019 (actual)
- 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.
Lymphoma is one of the fastest growing malignancies in the world, with an annual incidence rate of about 4%. Non-Hodgkin's lymphoma (NHL) is highly heterogeneous and can be broadly divided into two major categories, B-cell lymphoma and T/NK cell lymphoma. It is composed of diseases of different pathological types and malignant degrees, and the prognosis is not the same.The anti-PD-1 antibody may benefit patients with relapsed or refractory Hodgkin's lymphoma. At the same time, in non-Hodgkin's lymphoma, PD1 antibodies also show promising therapeutic prospects. We propose this research program, based on the previous research at home and abroad, to further clarify the role of PD-1 monoclonal antibody combined with chemotherapy in the treatment of relapsed and refractory NHL patients, evaluate its clinical efficacy and safety, and explore The best treatment strategy for patients with relapsed and refractory NHL in China.
Detailed description
Lymphoma is one of the fastest growing malignancies in the world, with an annual incidence rate of about 4%. In recent years, the incidence of malignant lymphoma in China has increased rapidly. It has risen to the ninth place among the top ten high-incidence tumors in men, and the female has risen to the eleventh place. In 2011, the incidence of lymphoma in the country has reached 6.43/100,000.
According to the characteristics of clinicopathology, lymphoma is divided into two categories: Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL). HL is a single disease, relatively rare, but the prognosis is good, and patients with limited period have no progress for 5 years. The survival rate was 85-95%, and the 5-year progression-free survival rate of advanced patients was 30-85%. NHL is highly heterogeneous and can be broadly divided into two major categories, B-cell lymphoma and T/NK cell lymphoma. It is composed of diseases of different pathological types and malignant degrees, and the prognosis is not the same.
In recent years, immunological checkpoint inhibitors have been the focus of research in the field of malignant tumor treatment. In clinical trials, PD-1/PD-L1 was found to be abnormally expressed in various lymphomas, including T-cell lymphoma, mediastinal large B-cell lymphoma, classical Hodgkin's lymphoma (CHL), and large variability. Cell lymphoma. Previous studies have evaluated the effects of antibody-based drugs against PD-1 (such as navobizumab and pabuleizumab) in patients with relapsed or refractory classic Hodgkin's lymphoma, and A higher response rate is shown and the security feature is acceptable. The domestic ORIENT-1 study showed that ididilimumab was highly active in patients with relapsed or refractory classic Hodgkin's lymphoma in China, and 80% (74/92) patients had an objective response. No patients died during the study. Of the 96 patients treated, 89 (93%) had treatment-related adverse events, including 17 (18%) patients with grade 3 or 4 treatment-related adverse events, and 11 patients (11%) experienced severe Adverse events, but no unexpected or off-target safety signals were found. Therefore, PD1 antibodies may benefit patients with relapsed or refractory Hodgkin's lymphoma.
At the same time, in non-Hodgkin's lymphoma, PD1 antibodies also show promising therapeutic prospects. Clinical studies at home and abroad have shown that PD-1 inhibitors are effective in relapsed or refractory extranodal NKT lymphoma. The results of the Idiliumab ORIENT-4 test showed that 1 year OS 82.1%, ORR 67.9%, DCR 85.7%, and PD-1 inhibitor combined with citabin to treat relapsed or refractory extranodal NKT is underway; PD-1 inhibitor monotherapy for relapsed or refractory PTCL is generally effective (ORR 33%, 4 of them CR); PD-1 inhibitor monotherapy is effective in treating relapsed or refractory mycosis/Sezary syndrome (ORR) 37.5%) has been recommended by the NCCN guidelines; trials in combination with IFN γ-1b are underway. PD-1 inhibitor monotherapy for relapsed or refractory PMBCL or PCNSL is effective, and PD-1 inhibitors have been recommended by the NCCN guidelines for the former treatment.
Therefore, we propose this research program, based on the previous research at home and abroad, to further clarify the role of PD-1 monoclonal antibody combined with chemotherapy in the treatment of relapsed and refractory NHL patients, evaluate its clinical efficacy and safety, and explore The best treatment strategy for patients with relapsed and refractory NHL in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD-1 combined with chemotherapy | Experimental | Drug: PD-1 combined with chemotherapy21 days every cycle, assessment after 3-cycle |
| chemotherapy | Active comparator | Drug: chemotherapy21 days every cycle, assessment after 3-cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Non-Hodgkin's lymphoma (NHL) confirmed by histopathology, preferably in the detection of tumor tissue PD-L1 expression.
- A recurrent or refractory disease defined as: 1) recurrence of disease after complete remission (CR); or 2) partial remission (PR), disease stabilization (SD), or disease Progress (PD) when the treatment is completed prior to enrollment in the study.
- Age≥18 years old, both men and women.
- The ECOG score is 0-2.
- There is at least one evaluable lesion (maximum diameter>15mm or shortest diameter>10mm). Preferably, PET-CT shows high metabolism of FDG.
Key exclusion criteria (14 listed)
- Age<18 years old；
- Received ASCT within 90 days prior to the first use of the study drug;
- Severe allergies, or patients known to be allergic or intolerant of the drug components of the chemotherapy regimen;
- Active, unrecognized or suspected autoimmune disease, or a history of autoimmune disease within 2 years;
- Previously exposed to any antibody against PD-1, PD-L1 or cytotoxic T lymphocyte-associated antigen 4
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 |
|---|---|---|
| PD-1 combined with chemotherapyAlso: PD-1 combined with chemotherapy groupPD-1 200 mg，d1; Rituximab 375mg/m2，d0（ the same as the chemotherapy group） The chemotherapy chooses one of the following: GDP：Gemcitabine 800-1000mg/m2, d1、8; Cisplatin 25mg/m2, d1-3; Dexamethasone 40mg, d1-4; GemOx：Gemcitabine 800-1000mg/m2, d1、8; Oxaliplatin 130mg/m2，d1; DA-EPOCH：Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5; ICE: Ifosfamide 1g/m２，d1-4; Cisplatin 25mg/m２, d1-4; Etoposide 60 mg／m２，d1-4; DICE: Ifosfamide 1 g／m２，dl-d4; Cisplatin 25mg/m２, d1-4; Etoposide 60 mg／m２，d1-4; Dexamethasone 10-20mg，d1-4; High dose MTX（Central recurrence）：MTX 3.5g／ｍ２,ｄ1; Hyper CVAD（B）：MTX 1g／ｍ２, d1; Cytarabine 2-3g／ｍ２, q12h, d2-3 | Drug | PD-1 combined with chemotherapy |
| chemotherapyAlso: chemotherapy groupRituximab 375mg/m2，d0（ Except for patients who relapsed within12 months after the last application of rituximab） The chemotherapy chooses one of the following: GDP：Gemcitabine 800-1000mg/m2, d1、8; Cisplatin 25mg/m2, d1-3; Dexamethasone 40mg, d1-4; GemOx：Gemcitabine 800-1000mg/m2, d1、8; Oxaliplatin 130mg/m2，d1; DA-EPOCH：Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5; ICE: Ifosfamide 1g/m２，d1-4; Cisplatin 25mg/m２, d1-4; Etoposide 60 mg／m２，d1-4; DICE: Ifosfamide 1 g／m２，dl-d4; Cisplatin 25mg/m２, d1-4; Etoposide 60 mg／m２，d1-4; Dexamethasone 10-20mg，d1-4; High dose MTX（Central recurrence）：MTX 3.5g／ｍ２,ｄ1; Hyper CVAD（B）：MTX 1g／ｍ２, d1; Cytarabine 2-3g／ｍ２, q12h, d2-3 | Drug | chemotherapy |
Primary outcome
Overall response rate
Time frame: 2 years
Percentage of patients with complete remission （CR）or partial remission （PR）
2 secondary outcomes
Progression free survival（PFS）
Time frame: 2 years
overall survival（OS）
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 22 Oct 2019.
- 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.
Wang Xin, MD,PhD principal investigator
Shandong Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PD-1 combined with chemotherapy and chemotherapy in people with Relapsed/Refractory Non-Hodgkin's Lymphoma, run by Shandong Provincial Hospital 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 10 inclusion and 14 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 22 Oct 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?
Contact Wang Xin, MD,PhD (+86-531-68778331, xinw8331@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: 2 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 22 Oct 2019.