Peripheral T Cell LymphomaNCT04213209

Special Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Pediatric Hodgkin Lymphoma"

An observational study of Peripheral T Cell Lymphoma and Pediatric Hodgkin Lymphoma, run by Takeda at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this survey is to examine the safety of adult patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL) (excluding anaplastic large cell lymphoma (ALCL)) and pediatric patients with relapsed or refractory CD30-positive PTCL or Hodgkin lymphoma (HL) in the actual use of on… Read more about this study

Who is it for?: Any age
Conditions the study is for: Peripheral T Cell Lymphoma, Pediatric Hodgkin Lymphoma
What is being tested?: Brentuximab Vedotin (Genetical Recombination)
Type of treatment: Injection or infusion
How many people: 95 participants
Where: 1 siteJapan
Study dates: 14 Feb 2020to 13 Dec 2023
Phase: Observational
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients with relapsed or refractory CD30-positive PTCL (excluding ALCL) and pediatric patients with relapsed or refractory CD30-positive PTCL or HL as part of routine medical care.

Who may be able to join

Participants with relapsed or refractory lymphoma.
CD30-positive participants.
Participants who receive study drug after obtaining approval of CD30-positive PTCL indication of study drug.

Who cannot join

Participants with a history of severe hypersensitivity to Brentuximab Vedotin.
Participants taking bleomycin hydrochloride treatment.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Takeda Selected Site
Tokyo

Other trials in Japan

About this study

Official title: Special Drug Use Surveillance for Adcetris Intravenous Infusion 50 Milligrams "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Hodgkin Lymphoma (Only Pediatric Patients)"

Read the detailed description

The drug being tested in this survey is called Brentuximab Vedotin intravenous infusion 50 mg. This intravenous infusion is being tested to treat adult patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL) (excluding anaplastic large cell lymphoma (ALCL)) and pediatric patients with relapsed or refractory CD30-positive PTCL or Hodgkin lymphoma (HL).

This survey is an observational (non-interventional) study and will look at the safety of adult patients with relapsed or refractory CD30-positive PTCL (excluding ALCL) and pediatric patients with relapsed or refractory CD30-positive PTCL or HL in the routine clinical setting. The number of observed patients will be approximately 86 as total (80; Adult participants and 6; Pediatric participants).

This multi-center observational survey will be conducted in Japan.

Conditions: Peripheral T Cell Lymphoma, Pediatric Hodgkin Lymphoma
Being tested: Brentuximab Vedotin (Genetical Recombination)
Medical subject headings: Lymphoma, T-Cell, Peripheral

What participants receive

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

Brentuximab Vedotin (Genetical Recombination)Drug
Also called ADCETRIS Intravenous Infusion 50 mg
Brentuximab Vedotin Intravenous Infusion

Study groups in NCT04213209
Study group	Role	What they receive
Brentuximab Vedotin 1.8 mg/kg (body weight)		The usual dosage for intravenous administration is 1.8 milligrams per kilograms (mg/kg) (body weight) as Brentuximab Vedotin (genetic recombination) once every three weeks (up to 12 months). The dose may be reduced appropriately according to the participant's condition. Participants receive interventions as part of routine medical care. Receives: Drug: Brentuximab Vedotin (Genetical Recombination)

What is being measured

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

Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Percentage of participants who had one or more serious or non-serious adverse event of peripheral motor neuropathy or peripheral sensory neuropathy which were classified as peripheral neuropathy was reported.
Measured: Up to 12 Months
Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. Percentage of participants who had one or more serious or non-serious adverse drug reaction of peripheral motor neuropathy or peripheral sensory neuropathy which were classified as peripheral neuropathy was reported.
Measured: Up to 12 Months
Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Percentage of participants who had one or more serious or non-serious adverse event of febrile neutropenia, neutropenia, or neutrophil count decreased which were classified as myelosuppression was reported.
Measured: Up to 12 Months
Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. Percentage of participants who had one or more serious or non-serious adverse drug reaction of febrile neutropenia, neutropenia, or neutrophil count decreased which were classified as myelosuppression was reported.
Measured: Up to 12 Months
Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Percentage of participants who had one or more serious or non-serious adverse event of only interstitial lung disease which were classified as lung disorder was reported.
Measured: Up to 12 Months
Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. Percentage of participants who had one or more serious or non-serious adverse drug reaction of only interstitial lung disease which were classified as lung disorder was reported.
Measured: Up to 12 Months

Secondary outcomes (5)

Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With PTCL-NOS, AITL, the Other PTCL, and Pediatric Participants With PTCL
Best response is defined as the cumulative numbers of participants who achieve each level of best response including complete response (CR), complete response uncertain (CRu) (when no positron emission tomography [PET] data are available), partial response (PR), Stable Disease (SD), and Progressive Disease (PD) after treatment. Best response was assessed by the antitumor response criteria for adult PTCL. Reported data are divided into 2 populations; with or without PET data for each group. PET was used in cancer diagnosis and treatment.
Measured: Up to 12 Months
Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With ATLL
Best response is defined as the cumulative numbers of participants who achieve each level of best response including complete response (CR), partial response (PR), Stable Disease (SD), and Progressive Disease (PD) after treatment. Best response was assessed by the antitumor response criteria.
Measured: Up to 12 Months
Percentage of Participants Who Achieve or Maintain Any Best Response for Pediatric Participants With PTCL and HL
Best response is defined as the cumulative numbers of participants who achieve each level of best response including complete response (CR), complete response uncertain (CRu) (for PTCL), partial response (PR), Stable Disease (SD), and Progressive Disease (PD) after treatment. Best response was assessed by the Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) version of antitumor response criteria.
Measured: Up to 12 Months
Percentage of Participants Who Had One or More Adverse Event
AE is defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
Measured: Up to 12 Months
Percentage of Participants Who Had One or More Adverse Drug Reaction
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
Measured: Up to 12 Months

Timeline

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

14 Feb 202013 Dec 2023

First posted30 Dec 2019
Study start14 Feb 2020
Primary completion13 Dec 2023
Study completion13 Dec 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.
Other trials for Peripheral T Cell LymphomaStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04213209
Sponsor's protocol ID: C25021
Other IDs: jRCT1080224999
Status last verified: Jun 2024
First submitted: 25 Dec 2019
Last updated: 27 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

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

RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
RecruitingPhase 1/2
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
Peripheral T Cells Lymphoma (PTCL), Follicular Helper T-Cell Lymphoma
Active, not recruitingPhase 2
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma

All Peripheral T Cell Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Special Drug Use Surveillance for Adcetris Intravenous Infusion 50 Milligrams "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Hodgkin Lymphoma (Only Pediatric Patients)"
ClinicalTrials.gov ID: NCT04213209
Acronym / sponsor ID: C25021
Conditions: Peripheral T Cell Lymphoma, Pediatric Hodgkin Lymphoma
Study type: Observational
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 14 Feb 2020 (actual)
Primary completion: 13 Dec 2023 (actual)
Study completion: 13 Dec 2023 (actual)
First posted: 30 Dec 2019 (actual)
Results: Posted 27 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This multi-center observational survey will be conducted in Japan.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Brentuximab Vedotin 1.8 mg/kg (body weight)	–	Drug: Brentuximab Vedotin (Genetical Recombination)The usual dosage for intravenous administration is 1.8 milligrams per kilograms (mg/kg) (body weight) as Brentuximab Vedotin (genetic recombination) once every three weeks (up to 12 months). The dose may be reduced appropriately according to the participant's condition. Participants receive interventions as part of routine medical care.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with relapsed or refractory CD30-positive PTCL (excluding ALCL) and pediatric patients with relapsed or refractory CD30-positive PTCL or HL as part of routine medical care.

Key inclusion criteria (3 listed)

Participants with relapsed or refractory lymphoma.
CD30-positive participants.
Participants who receive study drug after obtaining approval of CD30-positive PTCL indication of study drug.

Key exclusion criteria (2 listed)

Participants with a history of severe hypersensitivity to Brentuximab Vedotin.
Participants taking bleomycin hydrochloride treatment.

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
Brentuximab Vedotin (Genetical Recombination)Also: ADCETRIS Intravenous Infusion 50 mgBrentuximab Vedotin Intravenous Infusion	Drug	Brentuximab Vedotin 1.8 mg/kg (body weight)

Primary outcome

Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy
Time frame: Up to 12 Months
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Percentage of participants who had one or more serious or non-serious adverse event of peripheral motor neuropathy or peripheral sensory neuropathy which were classified as peripheral neuropathy was reported.
Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy
Time frame: Up to 12 Months
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. Percentage of participants who had one or more serious or non-serious adverse drug reaction of peripheral motor neuropathy or peripheral sensory neuropathy which were classified as peripheral neuropathy was reported.
Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression
Time frame: Up to 12 Months
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Percentage of participants who had one or more serious or non-serious adverse event of febrile neutropenia, neutropenia, or neutrophil count decreased which were classified as myelosuppression was reported.
Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression
Time frame: Up to 12 Months
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. Percentage of participants who had one or more serious or non-serious adverse drug reaction of febrile neutropenia, neutropenia, or neutrophil count decreased which were classified as myelosuppression was reported.
Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder
Time frame: Up to 12 Months
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Percentage of participants who had one or more serious or non-serious adverse event of only interstitial lung disease which were classified as lung disorder was reported.
Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder
Time frame: Up to 12 Months
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. Percentage of participants who had one or more serious or non-serious adverse drug reaction of only interstitial lung disease which were classified as lung disorder was reported.

5 secondary outcomes

Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With PTCL-NOS, AITL, the Other PTCL, and Pediatric Participants With PTCL
Time frame: Up to 12 Months
Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With ATLL
Time frame: Up to 12 Months
Percentage of Participants Who Achieve or Maintain Any Best Response for Pediatric Participants With PTCL and HL
Time frame: Up to 12 Months
Percentage of Participants Who Had One or More Adverse Event
Time frame: Up to 12 Months
Percentage of Participants Who Had One or More Adverse Drug Reaction
Time frame: Up to 12 Months

Results and safety

Results posted to the registry on 27 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adult Participants With PTCL-NOS	32	31
Adult Participants With AITL	35	35
Adult Participants With ATLL	14	14
Adult Participants With Other PTCL	6	6
Pediatric Participants With PTCL	4	4
Pediatric Participants With HL	4	4

Primary outcome: Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy

Time frame: Up to 12 Months. Count of participants. Unit: Participants

Measure	Adult Participants With PTCL-NOS n = 31	Adult Participants With AITL n = 35	Adult Participants With ATLL n = 14	Adult Participants With Other PTCL n = 6	Pediatric Participants With PTCL n = 4
Serious: Peripheral Motor Neuropathy	0	0	0	0	0
Non-Serious: Peripheral Motor Neuropathy	1	0	0	1	0
Serious: Peripheral Sensory Neuropathy	0	1	0	0	0
Non-Serious: Peripheral Sensory Neuropathy	8	9	2	1	2

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

Primary outcome: Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy

Time frame: Up to 12 Months. Count of participants. Unit: Participants

Measure	Adult Participants With PTCL-NOS n = 31	Adult Participants With AITL n = 35	Adult Participants With ATLL n = 14	Adult Participants With Other PTCL n = 6	Pediatric Participants With PTCL n = 4
Serious: Peripheral Motor Neuropathy	0	0	0	0	0
Non-Serious: Peripheral Motor Neuropathy	1	0	0	1	0
Serious: Peripheral Sensory Neuropathy	0	1	0	0	0
Non-Serious: Peripheral Sensory Neuropathy	8	9	2	1	2

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

Primary outcome: Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression

Time frame: Up to 12 Months. Count of participants. Unit: Participants

Measure	Adult Participants With PTCL-NOS n = 31	Adult Participants With AITL n = 35	Adult Participants With ATLL n = 14	Pediatric Participants With PTCL n = 4	Pediatric Participants With HL n = 4
Serious: Febrile Neutropenia	1	1	0	1	0
Non-Serious: Febrile Neutropenia	0	0	0	0	0
Serious: Neutropenia	1	0	0	1	0
Non-Serious: Neutropenia	0	0	0	0	0
Serious: Neutrophil Count Decreased	3	0	0	0	0
Non-Serious: Neutrophil Count Decreased	9	3	2	0	1

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

Primary outcome: Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression

Time frame: Up to 12 Months. Count of participants. Unit: Participants

Measure	Adult Participants With PTCL-NOS n = 31	Adult Participants With AITL n = 35	Adult Participants With ATLL n = 14
Serious: Febrile Neutropenia	1	0	0
Non-Serious: Febrile Neutropenia	0	0	0
Serious: Neutropenia	1	0	0
Non-Serious: Neutropenia	0	0	0
Serious: Neutrophil Count Decreased	3	0	0
Non-Serious: Neutrophil Count Decreased	9	3	2

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 12 Months. Other adverse events reported at 5.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adult Participants With PTCL-NOS	8 of 31 (25.8%)	18 of 31 (58.1%)	1 of 31
Adult Participants With AITL	12 of 35 (34.3%)	14 of 35 (40%)	5 of 35
Adult Participants With ATLL	2 of 14 (14.3%)	6 of 14 (42.9%)	2 of 14
Adult Participants With Other PTCL	1 of 6 (16.7%)	4 of 6 (66.7%)	0 of 6
Pediatric Participants With PTCL	3 of 4 (75%)	2 of 4 (50%)	0 of 4
Pediatric Participants With HL	2 of 4 (50%)	2 of 4 (50%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain more information on the study, click here/on this linkLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Related trials for Peripheral T Cell Lymphoma

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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.

Study Director study director

Takeda

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

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral T Cell Lymphoma and Pediatric Hodgkin Lymphoma, run by Takeda at 1 site in Japan.

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 3 inclusion and 2 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 27 Sep 2024. 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 Japan. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 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?

Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy (time frame: Up to 12 Months). The study lists 6 primary outcomes in all. 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 NCT04213209.

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 27 Sep 2024.