Follicular LymphomaPhase 3FLINTERNCT03976102
Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma
A Phase 3 study testing DRL_RI (Proposed rituximab biosimilar) and MabThera® in people with Follicular Lymphoma, run by Dr. Reddy's Laboratories Limited at 4 sites in United States.
Trial summary
The primary objective of the current study is to demonstrate the equivalent efficacy of rituximab (DRL_RI) and MabThera® in subjects with Low Tumor Burden Follicular Lymphoma (LTB-FL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- DRL_RI (Proposed rituximab biosimilar) and MabThera®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 May 2019to 27 Feb 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject is Male or female subjects aged ≥18 years of age.
- Subject is histologically confirmed, Grade 1-3a, previous ly untreated, CD20-pos itive.
- Subject has Ann Arbor Stage II to IV and ECOG status of 0 to 1.
- Subject has Low tumor burden follicular lymphoma as per Groupe d'Etude des Lymphomes Folliculaires (GELF) Criteria
- Subject has at least 1 measurable tumor mass in 2 dimensions, and the mass must be:
- Nodal lesion >15 mm in the longest dimension; or
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- Noda l lesion >10 mm to he longest dimension; dimens ion and >10 mm in the shortest dimension; or
- Extra-nodal lesion with both long and short dimensions ≥10 mm.
- Subject has Life expectancy ≥3 months.
- If female subject, then subject should be non-pregnant, non-lactating.
Who cannot join
- Subject with prior use of rituximab or any CD20 monoclonal antibody for any reason.
- Subjects with known hypersensitivity to rituximab or its excipients, or to proteins of murine or other foreign origin.
- Any prior therapy for follicular lymphoma (including but not limited to chemotherapy, radiotherapy) or subjects on chronic supra-substitutive doses of systemic gluco-corticosteriods.
- Subjects who, in the opinion of the Investigator, require additional concomitant treatment for lymphoma.
- Evidence of histologic transformation to high grade lymphoma or diffuse large B-cell lymphoma.
- Subjects with known sero-positivity for or history of active viral infection with human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) will be excluded. And if positive for hepatitis B core antibody or hepatitis C virus (HCV) antibody can only be enrolled if HBV - DNA level <20 IU/mL (or 112 copies/mL) and HCV - RNA is negative respectively by PCR test..
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- Subjects who have received a live vaccine within last 3 months of the first administration of study drug.
- Subjects with history or presence of a medical condition or disease that in the Investigator's opinion would place the subject at an unacceptable risk for study participation.
- Participation in any clinical study or having taken any investigational therapy (within 2-months of the first dose of study drug.
- Women of childbearing potential who do not consent to use highly effective methods of birth control.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
American Oncology Partners of Maryland
Bethesda, Maryland, 20817
Gulf coast Oncology Associates, PA
Houston, Texas, 77089
University of Tennessee Medical Center - Cancer Institute
Knoxville, Tennessee, 37920
The Oncology Institute of Hope and Innovation
Whittier, California, 90602
About this study
Official title: A Double-blind, Parallel-group, Phase III Study to Compare the Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in Subjects With Previously Untreated (CD)20-Positive LTB Follicular Lymphoma
The primary objective of the current study is to demonstrate the equivalent efficacy of rituximab (DRL_RI) and MabThera® in subjects with Low Tumor Burden Follicular Lymphoma (LTB-FL).
Also evaluated by Pharmacokinetic, safety, and immunogenicity assessment between a proposed biosimilar (DRL_RI) and the RMP, as an component of clinical study program, and collectively providing the evidence of biosimilarity.
The study will compare the safety and efficacy of DRL_RI vs MabThera in patients with Low Tumor Burden Follicular Lymphoma (LTB-FL). The primary objective is to establish comparative efficacy as measured by ORR up to week 28
Read the detailed description
It is planned to randomise approx. 312 subjects at approximately ≥ 130 study sites worldwide. Subjects with LTB-FL will be randomized to receive either DRL_RI or MabThera®. Till date, 68 patients have been randomized for the study.
The study specific objectives are mentioned below:
Primary Objective:
- To demonstrate the equivalent efficacy of DRL_RI (biosimilar rituximab) and MabThera in subjects with CD20-positive, LTB FL, as measured by overall response rate (ORR) up to Week 28 evaluated in accordance with Cheson, 1999 response criteria for Non-Hodgkin's Lymphomas.
Secondary Objectives:
- To compare the progression-free survival (PFS), overall survival (OS), and duration of response (DOR) of DRL_RI with MabThera® in subjects with CD20-positive, LTB FL.
- To compare the safety, tolerability, and immunogenicity of DRL_RI with MabThera in subjects with CD20-positive, LTB-FL.
Exploratory Objectives
- To explore the pharmacokinetic (PK) parameters of DRL_RI and MabThera, using a population-PK modelling approach.
- To explore the pharmacodynamic parameters of DRL_RI and MabThera.
- Conditions
- Follicular Lymphoma
- Being tested
- DRL_RI (Proposed rituximab biosimilar), MabThera®
- Keywords
- Follicular Lymphoma, Dr. Reddy's Rituximab, Biosimilar (DRL_RI), FLINTER
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRL_RI (Proposed rituximab biosimilar)Biological
Proposed rituximab biosimilar, 100mg and 500mg, concentrate for solution for infusion
MabThera®Other
Reference product rituximab, 100mg and 500mg, concentrate for solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm A: DRL_RI | Experimental | DRL_RI (rituximab-Dr. Reddy's Lab) for infusion 375 mg/m2 administered via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36 Receives: Biological: DRL_RI (Proposed rituximab biosimilar) |
| Arm B: MabThera® | Active comparator | MabThera® for infusion 375 mg/m2 administered via IV infusion on Days 1, 8, 15, 22 and Week 12, 20, 28 and 36. Receives: Other: MabThera® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Overall Response Rate (BORR) for Low Tumor Burden Follicular Lymphoma
Best Overall Response Rate (BORR) is defined as the proportion of participants in each treatment group that achieved a best overall response of either Complete response (CR), unconfirmed Complete response (CRu) or Partial response (PR), up to Month 7 (Week 28) based on central radiology review in accordance with the Cheson, 1999 response criteria for Non-Hodgkin's Lymphomas. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (CRu): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+CRu+PR.
Measured: Month 7 (Week 28)
Secondary outcomes (8)
Overall Response Rate (ORR)
The overall response rate (ORR) is defined as proportion of participants in each treatment group achieved a complete response or partial response at week 12 and week 28 based on central radiology review in accordance with published response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (uCR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+uCR+PR.
Measured: Week 12, Week 28
Complete Response Rate
Complete Response rate is defined as the proportion of participants in each treatment group who achieved complete response up to particular visit based on investigator assessment in accordance with the response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization.
Measured: Week 28
Complete Response Rate as a Best Response
Complete Response Rate as a Best Response is defined as the proportion of participants in each treatment group that achieved the best complete response up to Week 28 based on central radiology review in accordance with the Cheson 1999, response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization.
Measured: Week 28
Duration of Response (DOR)
Duration of response (DOR) defined as the time from date of the first documentation of tumor response (Complete Response, unconfirmed complete response or partial response) to the date of first documentation of progressive disease (PD) or to death due to any cause up to 52 weeks/ End of study (EOS). Progression is defined as per Cheson 1999, response criteria is:
Target Nodal SPD Progression: at least one node must be abnormal, and the SPD of all nodes must increase by ≥ 50% from its nadir SPD.
Target Extranodal SPD Progression: at least one extranodal lesion must be present and the SPD of all extranodal lesions must increase by ≥ 50% from its nadir SPD.
Also, if a patient had any unequivocal progression in non-target lesions; and detection of any new nodal lesion (longest diameter [LDi] 15mm with an absolute increase of 5mm) his/her response was considered as Progressive disease.
Measured: Week 52
Progression-free Survival (PFS)
Progression-free survival (PFS) is defined as the time from date of randomization to the date of documented progressive disease or death due to any cause. Progression is defined as per Cheson 1999, response criteria is:
Target Nodal SPD Progression: at least one node must be abnormal, and the SPD of all nodes must increase by ≥ 50% from its nadir SPD.
Target Extranodal SPD Progression: at least one extranodal lesion must be present and the SPD of all extranodal lesions must increase by ≥ 50% from its nadir SPD.
Also, if a patient had any unequivocal progression in non-target lesions; and detection of any new nodal lesion (LDi 15mm with an absolute increase of 5mm) his/her response was considered as Progressive disease.
Measured: Week 52
Overall Survival (OS)
The Overall survival (OS) defined as the time from date of randomization to the date of death from any cause up to 52 weeks or EOS.
Measured: Week 52
Number of Participants With Adverse Events
The safety and tolerability of DRL_RI and MabThera® in participants with CD20-positive, LTB-FL was evaluated.
Measured: From Screening (Day -28 to -1) up to 52 weeks
Number of Participants With Positive Anti-drug Antibody (ADA)
The immunogenicity of the Proposed Rituximab Biosimilar (DRL_RI) with MabThera® among trial participants was compared.
Measured: On Day 1, Week 2, Week 3, Week 4, Week 12 post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start15 May 2019
- Primary completion28 Sep 2022
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Follicular 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical Phase III, randomised, multicentre, double-blind study to demonstrate the equivalence of DRL\_RI to MabThera® in subjects with previously untreated, LTB-FL.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Eliso Sopia, MD, Study director, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976102
- Sponsor's protocol ID
- RI-01-006
- Acronym
- FLINTER
- Status last verified
- Jan 2024
- First submitted
- 15 Apr 2019
- Last updated
- 22 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Maharaj N, Uppada DR, Eswaraiah A, Kakkattu R, Reddy P, Kalenik VA, Belada D, Ramos AO, Kim JS, Baranau YV. Efficacy and safety of rituximab biosimilar (DRL_RI) versus MabThera(R) in low-tumor-burden follicular lymphoma: the FLINTER study. Ther Adv Med Oncol. 2025 May 24;17:17588359251339925. doi: 10.1177/17588359251339925. eCollection 2025.
PubMed 40421128
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Parallel-group, Phase III Study to Compare the Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in Subjects With Previously Untreated (CD)20-Positive LTB Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT03976102
- Acronym / sponsor ID
- FLINTER / RI-01-006
- Conditions
- Follicular Lymphoma
- Keywords
- Follicular Lymphoma, Dr. Reddy's Rituximab, Biosimilar (DRL_RI), FLINTER
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 15 May 2019 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Posted 22 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the current study is to demonstrate the equivalent efficacy of rituximab (DRL_RI) and MabThera® in subjects with Low Tumor Burden Follicular Lymphoma (LTB-FL).
Also evaluated by Pharmacokinetic, safety, and immunogenicity assessment between a proposed biosimilar (DRL_RI) and the RMP, as an component of clinical study program, and collectively providing the evidence of biosimilarity.
The study will compare the safety and efficacy of DRL_RI vs MabThera in patients with Low Tumor Burden Follicular Lymphoma (LTB-FL). The primary objective is to establish comparative efficacy as measured by ORR up to week 28
Detailed description
It is planned to randomise approx. 312 subjects at approximately ≥ 130 study sites worldwide. Subjects with LTB-FL will be randomized to receive either DRL_RI or MabThera®. Till date, 68 patients have been randomized for the study.
The study specific objectives are mentioned below:
Primary Objective:
- To demonstrate the equivalent efficacy of DRL_RI (biosimilar rituximab) and MabThera in subjects with CD20-positive, LTB FL, as measured by overall response rate (ORR) up to Week 28 evaluated in accordance with Cheson, 1999 response criteria for Non-Hodgkin's Lymphomas.
Secondary Objectives:
- To compare the progression-free survival (PFS), overall survival (OS), and duration of response (DOR) of DRL_RI with MabThera® in subjects with CD20-positive, LTB FL.
- To compare the safety, tolerability, and immunogenicity of DRL_RI with MabThera in subjects with CD20-positive, LTB-FL.
Exploratory Objectives
- To explore the pharmacokinetic (PK) parameters of DRL_RI and MabThera, using a population-PK modelling approach.
- To explore the pharmacodynamic parameters of DRL_RI and MabThera.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Clinical Phase III, randomised, multicentre, double-blind study to demonstrate the equivalence of DRL_RI to MabThera® in subjects with previously untreated, LTB-FL.
| Arm | Type | Receives |
|---|---|---|
| Arm A: DRL_RI | Experimental | Biological: DRL_RI (Proposed rituximab biosimilar)DRL_RI (rituximab-Dr. Reddy's Lab) for infusion 375 mg/m2 administered via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36 |
| Arm B: MabThera® | Active comparator | Other: MabThera®MabThera® for infusion 375 mg/m2 administered via IV infusion on Days 1, 8, 15, 22 and Week 12, 20, 28 and 36. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is Male or female subjects aged ≥18 years of age.
- Subject is histologically confirmed, Grade 1-3a, previous ly untreated, CD20-pos itive.
- Subject has Ann Arbor Stage II to IV and ECOG status of 0 to 1.
- Subject has Low tumor burden follicular lymphoma as per Groupe d'Etude des Lymphomes Folliculaires (GELF) Criteria
- Subject has at least 1 measurable tumor mass in 2 dimensions, and the mass must be:
Key exclusion criteria (10 listed)
- Subject with prior use of rituximab or any CD20 monoclonal antibody for any reason.
- Subjects with known hypersensitivity to rituximab or its excipients, or to proteins of murine or other foreign origin.
- Any prior therapy for follicular lymphoma (including but not limited to chemotherapy, radiotherapy) or subjects on chronic supra-substitutive doses of systemic gluco-corticosteriods.
- Subjects who, in the opinion of the Investigator, require additional concomitant treatment for lymphoma.
- Evidence of histologic transformation to high grade lymphoma or diffuse large B-cell lymphoma.
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 |
|---|---|---|
| DRL_RI (Proposed rituximab biosimilar)Proposed rituximab biosimilar, 100mg and 500mg, concentrate for solution for infusion | Biological | Arm A: DRL_RI |
| MabThera®Reference product rituximab, 100mg and 500mg, concentrate for solution for infusion | Other | Arm B: MabThera® |
Primary outcome
Best Overall Response Rate (BORR) for Low Tumor Burden Follicular Lymphoma
Time frame: Month 7 (Week 28)
Best Overall Response Rate (BORR) is defined as the proportion of participants in each treatment group that achieved a best overall response of either Complete response (CR), unconfirmed Complete response (CRu) or Partial response (PR), up to Month 7 (Week 28) based on central radiology review in accordance with the Cheson, 1999 response criteria for Non-Hodgkin's Lymphomas. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (CRu): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+CRu+PR.
8 secondary outcomes
Overall Response Rate (ORR)
Time frame: Week 12, Week 28
Complete Response Rate
Time frame: Week 28
Complete Response Rate as a Best Response
Time frame: Week 28
Duration of Response (DOR)
Time frame: Week 52
Progression-free Survival (PFS)
Time frame: Week 52
Overall Survival (OS)
Time frame: Week 52
Number of Participants With Adverse Events
Time frame: From Screening (Day -28 to -1) up to 52 weeks
Number of Participants With Positive Anti-drug Antibody (ADA)
Time frame: On Day 1, Week 2, Week 3, Week 4, Week 12 post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40421128Maharaj N, Uppada DR, Eswaraiah A, Kakkattu R, Reddy P, Kalenik VA, Belada D, Ramos AO, Kim JS, Baranau YV. Efficacy and safety of rituximab biosimilar (DRL_RI) versus MabThera(R) in low-tumor-burden follicular lymphoma: the FLINTER study. Ther Adv Med Oncol. 2025 May 24;17:17588359251339925. doi: 10.1177/17588359251339925. eCollection 2025.
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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.
Eliso Sopia, MD study director
Parexel
4 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 DRL_RI (Proposed rituximab biosimilar) and MabThera® in people with Follicular Lymphoma, run by Dr. Reddy's Laboratories Limited at 4 sites in United States.
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 10 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: finished, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Yes. Results are posted in the registry (first posted 22 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Overall Response Rate (BORR) for Low Tumor Burden Follicular Lymphoma (time frame: Month 7 (Week 28)). 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 NCT03976102, which also lists 1 linked publication.
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 Jan 2024.