Trial · NCT04213209

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

NCT04213209, Completed, Takeda; results first posted 2024-09-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Special Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Pediatric Hodgkin Lymphoma". Trials, record NCT04213209. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04213209

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Special Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Pediatric Hodgkin Lymphoma"
NCT number: NCT04213209
Status: Completed
Enrollment: 95 participants, actual
Lead sponsor: Takeda
Conditions: Peripheral T Cell Lymphoma, Pediatric Hodgkin Lymphoma
Interventions: Brentuximab Vedotin (Genetical Recombination)
First posted: 2019-12-30
Last updated: 2024-09-27
Results first posted: 2024-09-27

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy	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.
Primary	Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy	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.
Primary	Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression	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.
Primary	Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression	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.
Primary	Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder	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.
Primary	Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder	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.
Secondary	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	Up to 12 Months	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.
Secondary	Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With ATLL	Up to 12 Months	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.
Secondary	Percentage of Participants Who Achieve or Maintain Any Best Response for Pediatric Participants With PTCL and HL	Up to 12 Months	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.
Secondary	Percentage of Participants Who Had One or More Adverse Event	Up to 12 Months	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.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy	Up to 12 Months	Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy	Up to 12 Months	Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression	Up to 12 Months	Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression	Up to 12 Months	Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder	Up to 12 Months	Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder	Up to 12 Months	Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	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	Up to 12 Months	Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With ATLL	Up to 12 Months	Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Participants Who Achieve or Maintain Any Best Response for Pediatric Participants With PTCL and HL	Up to 12 Months	Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Participants Who Had One or More Adverse Event	Up to 12 Months	Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group167

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy	Adult Participants With PTCL-NOS	Serious: Peripheral Motor Neuropathy	0	Participants
Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy	Adult Participants With AITL	Serious: Peripheral Motor Neuropathy	0	Participants
Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy	Adult Participants With ATLL	Serious: Peripheral Motor Neuropathy	0	Participants
Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy	Adult Participants With Other PTCL	Serious: Peripheral Motor Neuropathy	0	Participants
Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy	Pediatric Participants With PTCL	Serious: Peripheral Motor Neuropathy	0	Participants
Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy	Pediatric Participants With HL	Serious: Peripheral Motor Neuropathy	0	Participants
Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy	Adult Participants With PTCL-NOS	Non-Serious: Peripheral Motor Neuropathy	1	Participants
Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy	Adult Participants With AITL	Non-Serious: Peripheral Motor Neuropathy	0	Participants
Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy	Adult Participants With ATLL	Non-Serious: Peripheral Motor Neuropathy	0	Participants
Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy	Adult Participants With Other PTCL	Non-Serious: Peripheral Motor Neuropathy	1	Participants

1 to 10 of 167Source ClinicalTrials.gov

See all 167 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Adult Participants With PTCL-NOS	32
Overall Study	STARTED	Adult Participants With AITL	35
Overall Study	STARTED	Adult Participants With ATLL	14
Overall Study	STARTED	Adult Participants With Other PTCL	6
Overall Study	STARTED	Pediatric Participants With PTCL	4
Overall Study	STARTED	Pediatric Participants With HL	4
Overall Study	COMPLETED	Adult Participants With PTCL-NOS	31
Overall Study	COMPLETED	Adult Participants With AITL	35
Overall Study	COMPLETED	Adult Participants With ATLL	14
Overall Study	COMPLETED	Adult Participants With Other PTCL	6

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events252

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Otitis media acute	Infections and infestations	Adult Participants With PTCL-NOS	0	31
other	Otitis media acute	Infections and infestations	Adult Participants With AITL	0	35
other	Otitis media acute	Infections and infestations	Adult Participants With ATLL	0	14
other	Otitis media acute	Infections and infestations	Adult Participants With Other PTCL	0	6
other	Otitis media acute	Infections and infestations	Pediatric Participants With PTCL	0	4
other	Otitis media acute	Infections and infestations	Pediatric Participants With HL	1	4
other	Upper respiratory tract infection	Infections and infestations	Adult Participants With PTCL-NOS	0	31
other	Upper respiratory tract infection	Infections and infestations	Adult Participants With AITL	0	35
other	Upper respiratory tract infection	Infections and infestations	Adult Participants With ATLL	0	14
other	Upper respiratory tract infection	Infections and infestations	Adult Participants With Other PTCL	0	6

1 to 10 of 252Source ClinicalTrials.gov

See all 252 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Adult Participants With PTCL-NOS	1	31
Total, all-cause mortality	Adult Participants With AITL	5	35
Total, all-cause mortality	Adult Participants With ATLL	2	14
Total, all-cause mortality	Adult Participants With Other PTCL	0	6
Total, all-cause mortality	Pediatric Participants With PTCL	0	4
Total, all-cause mortality	Pediatric Participants With HL	0	4
Total, other adverse events	Adult Participants With PTCL-NOS	18	31
Total, other adverse events	Adult Participants With AITL	14	35
Total, other adverse events	Adult Participants With ATLL	6	14
Total, other adverse events	Adult Participants With Other PTCL	4	6

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Pediatric Participants With PTCL vs Pediatric Participants With HL: Percentage of Participants Who Achieve or Maintain Any Best Response for Pediatric Participants With PTCL and HL

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04213209

GET https://conductscience.org/api/trials/v1/NCT04213209/results?page=2

API reference For AI assistants