Trial · NCT01492088
Study of Brentuximab Vedotin (SGN-35) in Pediatric Participants With Relapsed or Refractory (r/r) Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma
NCT01492088, Phase 1, Phase 2, Completed, Millennium Pharmaceuticals, Inc.; results first posted 2017-05-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Brentuximab Vedotin (SGN-35) in Pediatric Participants With Relapsed or Refractory (r/r) Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma. Trials, record NCT01492088. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01492088
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Brentuximab Vedotin (SGN-35) in Pediatric Participants With Relapsed or Refractory (r/r) Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma
- NCT number
- NCT01492088
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
- Relapsed or Refractory Hodgkin Lymphoma, Relapsed or Refractory Anaplastic Large-cell Lymphoma
- Interventions
- Brentuximab vedotin
- First posted
- 2011-12-14
- Last updated
- 2024-05-30
- Other registries' IDs
- eudract:2011-001240-29
- Results first posted
- 2017-05-15
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1) | From the first dose through 30 days after the last dose of study medication (Up to 15 months) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. |
| Primary | Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1) | From the first dose through 30 days after the last dose of study medication (Up to 15 months) | Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention. |
| Primary | Number of Participants With Clinically Significant Vital Signs Values Reported as AEs (Phase 1) | From the first dose through 30 days after the last dose of study medication (Up to 15 months) | Vital signs measurements included supine (after 3-5 minutes in this position) and standing (after 3-5 minutes in this position) measurements of diastolic and systolic blood pressure, heart rate, and oral temperature. |
| Primary | Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1) | Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose | Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate. |
| Primary | Serum Concentration of Total Antibodies (Conjugated and Unconjugated) (Phase 1) | Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose | Blood samples were collected and tested for conjugated and unconjugated antibodies. |
| Primary | Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1) | Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose | Blood samples were collected and tested for MMAE plasma concentrations. |
| Primary | Overall Response Rate (ORR) (Phase 1 and 2) | Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or end of treatment (EOT) (Up to 15 months) | Overall response rate is defined as the percentage of participants with complete remission (CR) or partial remission (PR) as assessed by an independent review facility (IRF) using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites. |
| Secondary | Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing ATA (nATA) (Phase 1 and 2) | Baseline up to EOT (Up to 15 months) | Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA and nATA development) using a laboratory test. ATA-positive samples were further characterized as transiently ATA positive (defined as 1 or 2 post-Baseline ATA-positive responses), persistently ATA positive (defined as more than 2 post-Baseline ATA positive responses), and nATA positive or negative. |
| Secondary | Overall Response Rate (ORR) (Phase 1) | Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT (Up to 15 months) | Overall response rate is defined as the percentage of participants with CR or PR as assessed by an IRF using IWG Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites. |
| Secondary | Time to Progression (TTP) (Phase 1 and 2) | Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months) | TTP is defined as the time in months from first dose until the first subsequent documentation of objective tumor progression. Progressive disease (PD) is defined as any new lesion or increase by ≥50% of previously involved sites from nadir. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1) | From the first dose through 30 days after the last dose of study medication (Up to 15 months) | Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1) | From the first dose through 30 days after the last dose of study medication (Up to 15 months) | Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Vital Signs Values Reported as AEs (Phase 1) | From the first dose through 30 days after the last dose of study medication (Up to 15 months) | Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1) | Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose | Data for this outcome measure was not summarized for Phase 1 participants only, data was summarized together for Phase 1 and 2 participants in brentuximab 1.4 mg/kg and 1.8 mg/kg arms groups. Data has been presented in OM 19. | ||
| PRIMARY | Serum Concentration of Total Antibodies (Conjugated and Unconjugated) (Phase 1) | Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose | Data for this outcome measure was not summarized for Phase 1 participants only, data was summarized together for Phase 1 and 2 participants in brentuximab 1.4 mg/kg and 1.8 mg/kg arms groups. Data has been presented in OM 20. | ||
| PRIMARY | Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1) | Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose | Data for this outcome measure was not summarized for Phase 1 participants only, data was summarized together for Phase 1 and 2 participants in brentuximab 1.4 mg/kg and 1.8 mg/kg arms groups. Data has been presented in OM 21. | ||
| PRIMARY | Overall Response Rate (ORR) (Phase 1 and 2) | Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or end of treatment (EOT) (Up to 15 months) | Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing ATA (nATA) (Phase 1 and 2) | Baseline up to EOT (Up to 15 months) | Participants from the Safety Population, all enrolled participants who received at least one dose of brentuximab vedotin, with data available for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate (ORR) (Phase 1) | Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT (Up to 15 months) | Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Participants enrolled in Phase 1 of the study were evaluated for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Time to Progression (TTP) (Phase 1 and 2) | Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months) | Safety population is defined as all participants who received at least 1 dose of study drug. TTP was censored on last radiological assessment of measured lesions documenting absence of PD for participants who did not have tumor progression. | months | MEDIAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group287
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1) | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | TEAE | 3 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1) | Brentuximab Vedotin 1.8 mg/kg: Phase 1 | TEAE | 9 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1) | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | SAE | 0 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1) | Brentuximab Vedotin 1.8 mg/kg: Phase 1 | SAE | 4 | Participants | |
| Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1) | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Gamma-glutamyltransferase increased | 0 | Participants | |
| Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1) | Brentuximab Vedotin 1.8 mg/kg: Phase 1 | Gamma-glutamyltransferase increased | 1 | Participants | |
| Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1) | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Transaminases increased | 0 | Participants | |
| Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1) | Brentuximab Vedotin 1.8 mg/kg: Phase 1 | Transaminases increased | 1 | Participants | |
| Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1) | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Lymphocyte count decreased | 1 | Participants | |
| Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1) | Brentuximab Vedotin 1.8 mg/kg: Phase 1 | Lymphocyte count decreased | 1 | Participants |
1 to 10 of 287Source ClinicalTrials.gov
See all 287 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 3 | |
| Overall Study | STARTED | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 16 | |
| Overall Study | STARTED | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 17 | |
| Overall Study | COMPLETED | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 0 | |
| Overall Study | COMPLETED | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 2 | |
| Overall Study | COMPLETED | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 3 | |
| Overall Study | NOT COMPLETED | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 3 | |
| Overall Study | NOT COMPLETED | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 14 | |
| Overall Study | NOT COMPLETED | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 14 |
Source ClinicalTrials.gov
Adverse events348
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 | Nausea | Gastrointestinal disorders | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 2 | 3 | |
| other | Nausea | Gastrointestinal disorders | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 7 | 16 | |
| other | Nausea | Gastrointestinal disorders | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 4 | 17 | |
| other | Vomiting | Gastrointestinal disorders | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 0 | 3 | |
| other | Vomiting | Gastrointestinal disorders | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 2 | 16 | |
| other | Vomiting | Gastrointestinal disorders | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 3 | 17 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 1 | 3 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 2 | 16 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 1 | 17 | |
| other | Abdominal pain | Gastrointestinal disorders | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 1 | 3 |
1 to 10 of 348Source ClinicalTrials.gov
See all 348 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 1 | 3 |
| Total, all-cause mortality | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 6 | 16 |
| Total, all-cause mortality | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 2 | 17 |
| Total, other adverse events | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 3 | 3 |
| Total, other adverse events | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 16 | 16 |
| Total, other adverse events | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 17 | 17 |
| Total, serious adverse events | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 0 | 3 |
| Total, serious adverse events | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 7 | 16 |
| Total, serious adverse events | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 1 | 17 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| Brentuximab Vedotin 1.4 mg/kg: Phase 1 vs Brentuximab Vedotin 1.8 mg/kg: Phase 1: Number of Participants With Clinically Significant Vital Signs Values Reported as AEs (Phase 1) |
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.
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/NCT01492088
GET https://conductscience.org/api/trials/v1/NCT01492088/registered?page=2