Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | PHASE3 | COMPLETED | 131 | — | — | Jun 11, 2012 | Jul 6, 2018 | Jan 5, 2021 | 41 | United States, Australia +10 |
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).
| Arm | Type | Description |
|---|---|---|
| Brentuximab vedotin | EXPERIMENTAL | 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). |
| Methotrexate or Bexarotene | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| Brentuximab Vedotin | DRUG | Brentuximab vedotin intravenous injection. |
| Methotrexate | DRUG | Methotrexate tablets. |
| Bexarotene | DRUG | Bexarotene tablets. |
Inclusion Criteria: * Voluntary consent form * Male or female participants 18 years or older with diagnosis of mycosis fungoides (MF) or primary cutaneous anaplastic large cell lymphoma (pcALCL) * Participants with pcALCL who have received prior radiation therapy or at least 1 prior systemic therap...