Trial · NCT01578499
A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Participants With CD30-Positive Cutaneous T-Cell Lymphoma (ALCANZA Study)
NCT01578499, Phase 3, Completed, Millennium Pharmaceuticals, Inc.; results first posted 2018-03-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Participants With CD30-Positive Cutaneous T-Cell Lymphoma (ALCANZA Study). Trials, record NCT01578499. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01578499
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Participants With CD30-Positive Cutaneous T-Cell Lymphoma (ALCANZA Study)
- NCT number
- NCT01578499
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 131 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
- Primary Cutaneous Anaplastic Large Cell Lymphoma, Mycosis Fungoides, Cutaneous T-Cell Lymphoma
- Interventions
- Brentuximab Vedotin, Methotrexate, Bexarotene
- First posted
- 2012-04-17
- Last updated
- 2021-01-05
- Other registries' IDs
- eudract:2010-024215-14
- Results first posted
- 2018-03-16
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4) | Each Cycle until disease progression, death End of treatment (Median overall follow-up 38.8 months) | ORR4 was determined by an Independent Review Facility (IRF) based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral radiographic assessment by an IRF and for the participants with mycosis fungoides (MF) only, detection of circulation Sezary cells. Participants whose first response occurred after the start of subsequent anticancer therapy were excluded. Response Criteria was based on International Society for Cutaneous Lymphomas (ISCL), United States Cutaneous Lymphoma Consortium (USCLC) and Cutaneous Lymphoma Task Force (CLTF) of the European Organisation for Research and Treatment of Cancer (EORTC) Consensus guidelines (Olsen, 2011). |
| Secondary | Percentage of Participants Achieving a CR | Each Cycle until disease progression, death or data cutoff (Median overall follow-up 38.8 months) | Complete Response (CR) was determined by the IRF based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral radiographic and for the participants with mycosis fungoides (MF) only, detection of circulation Sezary cells. Response Criteria was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011). |
| Secondary | Progression-Free Survival (PFS) | Until disease progression, death or data cutoff (Median PFS follow-up of 38.8 months) | PFS was assessed by the IRF and is defined as the time from randomization until disease progression or death due to any cause, whichever occurs first. Disease progression was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011). |
| Secondary | Maximum Change From Baseline in Symptom Domain Score of the Skindex-29 Questionnaire | Baseline up to End of Treatment (Week 52) | Skindex-29 is a 29-item dermatology-specific health-related quality of life (HRQoL). The Skindex-29 incorporates a 28-day recall period and consists of 3 domains: symptoms, emotions, and functioning. The domain scores and an overall score are expressed on a 100-point scale, from 0 to 100 with higher scores indicating lower levels of health- HRQoL. A negative change (reduction) from Baseline indicates improvement. |
| Secondary | Duration of Response (DOR) | Until disease progression, death or data cutoff (Median follow-up 38.8 months) | Duration of response was assessed by the IRF in participants with confirmed response \[CR or Partial Response (PR)\] and is defined as the time between first documentation of response and disease progression. Response Criteria was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011). |
| Secondary | DOR of Skin Response | Until disease progression, death or data cutoff (Median follow-up 38.8 months) | Duration of skin response (CR and PR) was assessed by the investigator and is defined as the time between the first skin response to progressive disease in skin. Per mSWAT, CR is defined as 100% clearance of skin lesions. PR is defined as 50%-99% clearance of skin disease from Baseline; No new tumors in participants without tumors at Baseline -MF; No new tumors-primary cutaneous anaplastic large cell lymphoma (pcALCL).Progressive disease is defined as ≥ 25% increase in skin disease from baseline, or loss of response: in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score, or new tumors in participants without tumors at baseline (MF). |
| Secondary | Event-Free Survival (EFS) | From randomization until disease progression, death or data cutoff (Median follow-up 36.8 months) | EFS was assessed by the IRF and is defined as the time from randomization until any cause of treatment failure: disease progression, discontinuation of treatment for any reason, or death due to any cause, whichever occurs first. Disease progression was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011). |
| Secondary | Cmax: Maximum Observed Concentration for Brentuximab Vedotin | Day 1 pre-dose and 30 minutes after infusion in Cycles 1 and 3 | |
| Secondary | Ctrough: Observed Concentration at the End of a Dosing Interval for Brentuximab Vedotin | Day 1 pre-dose of Cycles 2 and 4 | |
| Secondary | Cmax: Maximum Observed Concentration for Monomethyl Auristatin (MMAE) for Brentuximab Vedotin | Day 1 pre-dose and 30 minutes after infusion ended in Cycles 1 and 3 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4) | Each Cycle until disease progression, death End of treatment (Median overall follow-up 38.8 months) | The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a CR | Each Cycle until disease progression, death or data cutoff (Median overall follow-up 38.8 months) | The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | Until disease progression, death or data cutoff (Median PFS follow-up of 38.8 months) | The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. | months | MEDIAN |
| SECONDARY | Maximum Change From Baseline in Symptom Domain Score of the Skindex-29 Questionnaire | Baseline up to End of Treatment (Week 52) | The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Here number of participants analyzed are participants evaluable for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Duration of Response (DOR) | Until disease progression, death or data cutoff (Median follow-up 38.8 months) | The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Responders in ITT population were analyzed in this outcome measure. | months | MEDIAN |
| SECONDARY | DOR of Skin Response | Until disease progression, death or data cutoff (Median follow-up 38.8 months) | The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Skin responders in ITT population were analyzed in this outcome measure. | months | MEDIAN |
| SECONDARY | Event-Free Survival (EFS) | From randomization until disease progression, death or data cutoff (Median follow-up 36.8 months) | The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. | months | MEDIAN |
| SECONDARY | Cmax: Maximum Observed Concentration for Brentuximab Vedotin | Day 1 pre-dose and 30 minutes after infusion in Cycles 1 and 3 | The pharmacokinetic (PK) population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point. | ug/mL | MEAN |
| SECONDARY | Ctrough: Observed Concentration at the End of a Dosing Interval for Brentuximab Vedotin | Day 1 pre-dose of Cycles 2 and 4 | The PK population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point. | ug/mL | MEAN |
| SECONDARY | Cmax: Maximum Observed Concentration for Monomethyl Auristatin (MMAE) for Brentuximab Vedotin | Day 1 pre-dose and 30 minutes after infusion ended in Cycles 1 and 3 | The PK population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point. | ng/mL | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group132
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4) | Brentuximab Vedotin | 54.7 | 95% Confidence Interval 42.5 to 66.9 | percentage of participants | |
| Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4) | Methotrexate or Bexarotene | 12.5 | 95% Confidence Interval 4.4 to 20.6 | percentage of participants | |
| Percentage of Participants Achieving a CR | Brentuximab Vedotin | 17.2 | 95% Confidence Interval 7.9 to 26.4 | percentage of participants | |
| Percentage of Participants Achieving a CR | Methotrexate or Bexarotene | 1.6 | 95% Confidence Interval 0.0 to 8.4 | percentage of participants | |
| Progression-Free Survival (PFS) | Brentuximab Vedotin | 16.7 | 95% Confidence Interval 15.4 to 21.6 | months | |
| Progression-Free Survival (PFS) | Methotrexate or Bexarotene | 3.5 | 95% Confidence Interval 2.4 to 4.6 | months | |
| Maximum Change From Baseline in Symptom Domain Score of the Skindex-29 Questionnaire | Brentuximab Vedotin | -28.08 | Standard Deviation 26.863 | score on a scale | |
| Maximum Change From Baseline in Symptom Domain Score of the Skindex-29 Questionnaire | Methotrexate or Bexarotene | -8.62 | Standard Deviation 17.013 | score on a scale | |
| Duration of Response (DOR) | Brentuximab Vedotin | 15.1 | 95% Confidence Interval 9.8 to 25.5 | months | |
| Duration of Response (DOR) | Methotrexate or Bexarotene | 18.4 | 95% Confidence Interval 3.5 to NA | months |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Brentuximab Vedotin | 66 | |
| Overall Study | STARTED | Methotrexate or Bexarotene | 65 | |
| Overall Study | Safety Population: Treated | Brentuximab Vedotin | 66 | |
| Overall Study | Safety Population: Treated | Methotrexate or Bexarotene | 62 | |
| Overall Study | Intent to Treat Population: CD30+ | Brentuximab Vedotin | 64 | |
| Overall Study | Intent to Treat Population: CD30+ | Methotrexate or Bexarotene | 64 | |
| Overall Study | COMPLETED | Brentuximab Vedotin | 32 | |
| Overall Study | COMPLETED | Methotrexate or Bexarotene | 22 | |
| Overall Study | NOT COMPLETED | Brentuximab Vedotin | 34 | |
| Overall Study | NOT COMPLETED | Methotrexate or Bexarotene | 43 |
Source ClinicalTrials.gov
Adverse events190
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 sensory neuropathy | Nervous system disorders | Brentuximab Vedotin | 31 | 66 | |
| other | Peripheral sensory neuropathy | Nervous system disorders | Methotrexate or Bexarotene | 1 | 62 | |
| other | Peripheral motor neuropathy | Nervous system disorders | Brentuximab Vedotin | 4 | 66 | |
| other | Peripheral motor neuropathy | Nervous system disorders | Methotrexate or Bexarotene | 0 | 62 | |
| other | Paraesthesia | Nervous system disorders | Brentuximab Vedotin | 6 | 66 | |
| other | Paraesthesia | Nervous system disorders | Methotrexate or Bexarotene | 1 | 62 | |
| other | Dysgeusia | Nervous system disorders | Brentuximab Vedotin | 5 | 66 | |
| other | Dysgeusia | Nervous system disorders | Methotrexate or Bexarotene | 0 | 62 | |
| other | Headache | Nervous system disorders | Brentuximab Vedotin | 5 | 66 | |
| other | Headache | Nervous system disorders | Methotrexate or Bexarotene | 6 | 62 |
1 to 10 of 190Source ClinicalTrials.gov
See all 190 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brentuximab Vedotin | 22 | 66 |
| Total, all-cause mortality | Methotrexate or Bexarotene | 25 | 62 |
| Total, other adverse events | Brentuximab Vedotin | 60 | 66 |
| Total, other adverse events | Methotrexate or Bexarotene | 51 | 62 |
| Total, serious adverse events | Brentuximab Vedotin | 18 | 66 |
| Total, serious adverse events | Methotrexate or Bexarotene | 18 | 62 |
Source ClinicalTrials.gov
Papers5
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Brentuximab Vedotin vs Methotrexate or Bexarotene: deaths from any cause | Trial comparisons |
| Brentuximab Vedotin vs Methotrexate or Bexarotene: serious adverse events | 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.
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