TriangleNCT01578499 · STUDY IN CONTEXT
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)
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
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).
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).
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).
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.
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).
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).
Reported safety
Quality of life and patient-reported measures
EORTC QLQ · Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4)
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- qol key
- qol-0000
- source section id
- NCT01578499-om-0000
- source outcome index
- 0
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4)
- measure definition
- 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).
- time frame
- Each Cycle until disease progression, death End of treatment (Median overall follow-up 38.8 months)
- analysis role
- primary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Percentage of Participants Achieving a CR
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- qol key
- qol-0001
- source section id
- NCT01578499-om-0001
- source outcome index
- 1
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Percentage of Participants Achieving a CR
- measure definition
- 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).
- time frame
- Each Cycle until disease progression, death or data cutoff (Median overall follow-up 38.8 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Progression-Free Survival (PFS)
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- qol key
- qol-0002
- source section id
- NCT01578499-om-0002
- source outcome index
- 2
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Progression-Free Survival (PFS)
- measure definition
- 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).
- time frame
- Until disease progression, death or data cutoff (Median PFS follow-up of 38.8 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Maximum Change From Baseline in Symptom Domain Score of the Skindex-29 Questionnaire
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- qol key
- qol-0003
- source section id
- NCT01578499-om-0003
- source outcome index
- 3
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'health-related quality' in the study's own wording
- scale title
- Maximum Change From Baseline in Symptom Domain Score of the Skindex-29 Questionnaire
- measure definition
- 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.
- time frame
- Baseline up to End of Treatment (Week 52)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Duration of Response (DOR)
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- qol key
- qol-0004
- source section id
- NCT01578499-om-0004
- source outcome index
- 4
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Duration of Response (DOR)
- measure definition
- 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).
- time frame
- Until disease progression, death or data cutoff (Median follow-up 38.8 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Event-Free Survival (EFS)
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- qol key
- qol-0006
- source section id
- NCT01578499-om-0006
- source outcome index
- 6
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Event-Free Survival (EFS)
- measure definition
- 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).
- time frame
- From randomization until disease progression, death or data cutoff (Median follow-up 36.8 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Change From Baseline in the Skindex-29 Questionnaire Total Score
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- qol key
- qol-0012
- source section id
- NCT01578499-om-0012
- source outcome index
- 12
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'health-related quality' in the study's own wording
- scale title
- Change From Baseline in the Skindex-29 Questionnaire Total Score
- measure definition
- 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, 0 to 100 with higher scores indicating lower levels of health- HRQoL. A negative change (reduction) from Baseline indicates improvement.
- time frame
- Day 1 of Cycles 1, 2, 4, 6, 8, 10, 12, 14, 16, at End of Treatment (EOT) and during posttreatment long treatment follow-up (LTFU) - (Median follow-up 38.8 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- 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 analyzed' is the number of participants with evaluable data at the specified time-point.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
FACT · Change From Baseline in Functional Assessment of Cancer Therapy General Questionnaire (FACT-G) Score
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- qol key
- qol-0013
- source section id
- NCT01578499-om-0013
- source outcome index
- 13
- instrument
- FACT
- instrument basis
- matched 'fact-g' in the study's own wording
- scale title
- Change From Baseline in Functional Assessment of Cancer Therapy General Questionnaire (FACT-G) Score
- measure definition
- FACT-G is a 27-item general cancer QOL instrument completed by participants receiving cancer treatment. FACT-G incorporates a 7-day recall period and contains 4 primary subscales: Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28); Fact-G total score=sum of PWB, SWB, EWB, FWB, point range 0-108. Higher scores for the total scales and subscales indicate better quality of life. A negative change (reduction) from Baseline indicates improvement.
- time frame
- Day 1 of Cycles 1, 2, 4, 6, 8, 10, 12, 14, 16, at EOT and during posttreatment (LTFU) - (Median follow-up 38.8 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- Higher scores for the total scales and subscales indicate better
- population note
- 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 analyzed' is the number of participants with evaluable data at the specified time-point.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- trial label
- 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)
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 8
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- outcome key
- om-0000
- source section id
- NCT01578499-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4)
- endpoint definition
- 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).
- time origin
- Each Cycle until disease progression, death End of treatment (Median overall follow-up 38.8 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- outcome key
- om-0001
- source section id
- NCT01578499-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Participants Achieving a CR
- endpoint definition
- 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).
- time origin
- Each Cycle until disease progression, death or data cutoff (Median overall follow-up 38.8 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- outcome key
- om-0002
- source section id
- NCT01578499-om-0002
- source outcome index
- 2
- endpoint
- Progression-Free Survival (PFS)
- endpoint definition
- 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).
- time origin
- Until disease progression, death or data cutoff (Median PFS follow-up of 38.8 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- outcome key
- om-0003
- source section id
- NCT01578499-om-0003
- source outcome index
- 3
- endpoint
- Maximum Change From Baseline in Symptom Domain Score of the Skindex-29 Questionnaire
- endpoint definition
- 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.
- time origin
- Baseline up to End of Treatment (Week 52)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- outcome key
- om-0004
- source section id
- NCT01578499-om-0004
- source outcome index
- 4
- endpoint
- Duration of Response (DOR)
- endpoint definition
- 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).
- time origin
- Until disease progression, death or data cutoff (Median follow-up 38.8 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- outcome key
- om-0005
- source section id
- NCT01578499-om-0005
- source outcome index
- 5
- endpoint
- DOR of Skin Response
- endpoint definition
- 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).
- time origin
- Until disease progression, death or data cutoff (Median follow-up 38.8 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Brentuximab Vedotin
- regimen
- Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
- analyzed count
- 64
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01578499-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Methotrexate or Bexarotene
- regimen
- Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m\^2, tablets, orally, once daily with meals for up to 48 weeks.
- analyzed count
- 64
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01578499-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Brentuximab Vedotin
- regimen
- Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
- analyzed count
- 64
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01578499-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Methotrexate or Bexarotene
- regimen
- Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m\^2, tablets, orally, once daily with meals for up to 48 weeks.
- analyzed count
- 64
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01578499-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Brentuximab Vedotin
- regimen
- Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
- analyzed count
- 64
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01578499-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Methotrexate or Bexarotene
- regimen
- Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m\^2, tablets, orally, once daily with meals for up to 48 weeks.
- analyzed count
- 64
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01578499-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Brentuximab Vedotin
- regimen
- Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
- analyzed count
- 58
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01578499-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Methotrexate or Bexarotene
- regimen
- Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m\^2, tablets, orally, once daily with meals for up to 48 weeks.
- analyzed count
- 54
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01578499-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Brentuximab Vedotin
- regimen
- Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
- analyzed count
- 42
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01578499-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Methotrexate or Bexarotene
- regimen
- Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m\^2, tablets, orally, once daily with meals for up to 48 weeks.
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01578499-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Brentuximab Vedotin
- regimen
- Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
- analyzed count
- 47
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01578499-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Methotrexate or Bexarotene
- regimen
- Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m\^2, tablets, orally, once daily with meals for up to 48 weeks.
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01578499-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- harm key
- EG000
- source section id
- NCT01578499-ae
- event group key
- EG000
- event group label
- Brentuximab Vedotin
- serious affected
- 18
- serious at risk
- 66
- other affected
- 60
- other at risk
- 66
- frequency threshold
- 5
- collection period
- All-Cause mortality: Baseline up to End of study (Up to 6 years); Serious and Other adverse events: First dose of study drug through 30 days after last dose of study drug (Up to 450 days)
- event definition
- At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- harm key
- EG001
- source section id
- NCT01578499-ae
- event group key
- EG001
- event group label
- Methotrexate or Bexarotene
- serious affected
- 18
- serious at risk
- 62
- other affected
- 51
- other at risk
- 62
- frequency threshold
- 5
- collection period
- All-Cause mortality: Baseline up to End of study (Up to 6 years); Serious and Other adverse events: First dose of study drug through 30 days after last dose of study drug (Up to 450 days)
- event definition
- At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- qol key
- qol-0000
- source section id
- NCT01578499-om-0000
- source outcome index
- 0
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4)
- measure definition
- 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).
- time frame
- Each Cycle until disease progression, death End of treatment (Median overall follow-up 38.8 months)
- analysis role
- primary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- qol key
- qol-0001
- source section id
- NCT01578499-om-0001
- source outcome index
- 1
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Percentage of Participants Achieving a CR
- measure definition
- 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).
- time frame
- Each Cycle until disease progression, death or data cutoff (Median overall follow-up 38.8 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- qol key
- qol-0002
- source section id
- NCT01578499-om-0002
- source outcome index
- 2
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Progression-Free Survival (PFS)
- measure definition
- 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).
- time frame
- Until disease progression, death or data cutoff (Median PFS follow-up of 38.8 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- qol key
- qol-0003
- source section id
- NCT01578499-om-0003
- source outcome index
- 3
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'health-related quality' in the study's own wording
- scale title
- Maximum Change From Baseline in Symptom Domain Score of the Skindex-29 Questionnaire
- measure definition
- 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.
- time frame
- Baseline up to End of Treatment (Week 52)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- qol key
- qol-0004
- source section id
- NCT01578499-om-0004
- source outcome index
- 4
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Duration of Response (DOR)
- measure definition
- 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).
- time frame
- Until disease progression, death or data cutoff (Median follow-up 38.8 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- qol key
- qol-0006
- source section id
- NCT01578499-om-0006
- source outcome index
- 6
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Event-Free Survival (EFS)
- measure definition
- 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).
- time frame
- From randomization until disease progression, death or data cutoff (Median follow-up 36.8 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- qol key
- qol-0012
- source section id
- NCT01578499-om-0012
- source outcome index
- 12
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'health-related quality' in the study's own wording
- scale title
- Change From Baseline in the Skindex-29 Questionnaire Total Score
- measure definition
- 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, 0 to 100 with higher scores indicating lower levels of health- HRQoL. A negative change (reduction) from Baseline indicates improvement.
- time frame
- Day 1 of Cycles 1, 2, 4, 6, 8, 10, 12, 14, 16, at End of Treatment (EOT) and during posttreatment long treatment follow-up (LTFU) - (Median follow-up 38.8 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- 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 analyzed' is the number of participants with evaluable data at the specified time-point.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides
- nct id
- NCT01578499
- qol key
- qol-0013
- source section id
- NCT01578499-om-0013
- source outcome index
- 13
- instrument
- FACT
- instrument basis
- matched 'fact-g' in the study's own wording
- scale title
- Change From Baseline in Functional Assessment of Cancer Therapy General Questionnaire (FACT-G) Score
- measure definition
- FACT-G is a 27-item general cancer QOL instrument completed by participants receiving cancer treatment. FACT-G incorporates a 7-day recall period and contains 4 primary subscales: Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28); Fact-G total score=sum of PWB, SWB, EWB, FWB, point range 0-108. Higher scores for the total scales and subscales indicate better quality of life. A negative change (reduction) from Baseline indicates improvement.
- time frame
- Day 1 of Cycles 1, 2, 4, 6, 8, 10, 12, 14, 16, at EOT and during posttreatment (LTFU) - (Median follow-up 38.8 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- Higher scores for the total scales and subscales indicate better
- population note
- 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 analyzed' is the number of participants with evaluable data at the specified time-point.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice