Trial · NCT01396070
Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides With Variable CD30 Expression Level
NCT01396070, Phase 2, Completed, Youn Kim; results first posted 2017-04-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides With Variable CD30 Expression Level. Trials, record NCT01396070. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01396070
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides With Variable CD30 Expression Level
- NCT number
- NCT01396070
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Youn Kim
- Conditions
- Non-Hodgkin Lymphoma (NHL), Cutaneous Lymphoma, Cutaneous T-cell Lymphoma (CTCL), Mycosis Fungoides, Sezary Syndrome
- Interventions
- Brentuximab vedotin
- First posted
- 2011-07-18
- Last updated
- 2017-04-05
- Results first posted
- 2017-04-05
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | 2 years | Overall response rate of brentuximab vedotin in this study population. |
| Secondary | Overall Stable Disease Rate | 2 years | Overall Stable Disease Rate (SD) in this study population. 3 subjects were not evaluable. |
| Secondary | Overall Partial Response Rate | 2 years | Overall Partial Response Rate (PR) in this study population. 3 subjects were not evaluable. |
| Secondary | Overall Non-Evaluable Response | 4 weeks | Overall Non-Evaluable Response of full patient population 3 subjects were not evaluable. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | 2 years | The percentage was calculated by adding Complete response (CR) + Partial Response (PR) = Overall rate. 3 subjects were not evaluable. | percentage | NUMBER |
| SECONDARY | Overall Stable Disease Rate | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Partial Response Rate | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Non-Evaluable Response | 4 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Overall Response Rate (%) | Everyone evaluable (ORR) | 70 | percentage | |
| Overall Response Rate (ORR) | Overall Response Rate (%) | Tissue CD30 Expression Group A | 56 | percentage | |
| Overall Response Rate (ORR) | Overall Response Rate (%) | Tissue CD30 Expression Group B | 79 | percentage | |
| Overall Response Rate (ORR) | Overall Response Rate (%) | Tissue CD30 Expression Group C | 100 | percentage | |
| Overall Response Rate (ORR) | Overall Response Rate (%) | Stage IB | 83 | percentage | |
| Overall Response Rate (ORR) | Overall Response Rate (%) | Stage IIB | 94 | percentage | |
| Overall Response Rate (ORR) | Overall Response Rate (%) | Stage IV/SS | 63 | percentage | |
| Overall Response Rate (ORR) | Overall Response Rate (%) | Females | 30 | percentage | |
| Overall Response Rate (ORR) | Overall Response Rate (%) | Males | 69 | percentage | |
| Overall Stable Disease Rate | Brentuximab Vedotin | 5 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Brentuximab Vedotin | 36 | |
| Overall Study | COMPLETED | Brentuximab Vedotin | 17 | |
| Overall Study | NOT COMPLETED | Brentuximab Vedotin | 19 |
Source ClinicalTrials.gov
Adverse events31
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 | Events |
|---|---|---|---|---|---|---|
| other | Peripheral Neuropathy | Nervous system disorders | All Participants | 2 | 36 | 2 |
| other | Dyspepsia | Gastrointestinal disorders | All Participants | 3 | 36 | 3 |
| other | Skin eruption | Skin and subcutaneous tissue disorders | All Participants | 4 | 36 | 4 |
| other | Weight Loss | Social circumstances | All Participants | 3 | 36 | 3 |
| other | Aberrant T-cell population (blood) | Blood and lymphatic system disorders | All Participants | 2 | 36 | 2 |
| other | Dysphonia | Blood and lymphatic system disorders | All Participants | 2 | 36 | 2 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | All Participants | 2 | 36 | 2 |
| other | Hyponatremia | Blood and lymphatic system disorders | All Participants | 2 | 36 | 2 |
| other | Infusion Reaction | General disorders | All Participants | 2 | 36 | 2 |
| other | Leukopenia | Investigations | All Participants | 2 | 36 | 2 |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | ||
| Total, other adverse events | All Participants | 32 | 36 |
| Total, serious adverse events | All Participants | 23 | 36 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26195720 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT01396070
GET https://conductscience.org/api/trials/v1/NCT01396070/events?page=2