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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03703375 | Efficacy and Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma | PHASE3 | ACTIVE NOT_RECRUITING | 93 | — | — | Nov 6, 2018 | Mar 31, 2026 | Jul 8, 2024 | 12 | Japan |
PFS is defined as the time from randomization into the study to the first observation of documented disease progression (local assessment using Lugano Response Criteria 2014) or death due to any cause, whichever occurs first. If a participant has not progressed or died, PFS will be censored at the time of last visit with adequate assessment. C2 censoring rules were used per US FDA guidance 2015. Progression will be determined as per Response criteria for lymphoma: Lugano classification.
| Arm | Type | Description |
|---|---|---|
| Administration of Oral Azacitidine (CC-486) | EXPERIMENTAL | Oral azacytidine 300 mg during 14 first days of 28-days cycle for European (EU) patients, Oral azacytidine 200 mg during 14 first days of 28-days cycle for Asian patients (Treatment until progression, patient decision or toxicity) |
| Investigator's choice therapy - Romidepsin | ACTIVE_COMPARATOR | Romidepsin 14mg/m2 on days 1, 8 and 15 of a 28-days cycle (Treatment until progression, patient decision or toxicity) |
| Investigator's choice therapy - Gemcitabine | ACTIVE_COMPARATOR | Gemcitabine 1000mg/m2 on days 1, 8 and 15 of a 28-days cycle (during 6 cycles) |
| Name | Type | Description |
|---|---|---|
| Azacitidine | DRUG | Azacitidine |
| Romidepsin | DRUG | Romidepsin |
| Gemcitabine | DRUG | Gemcitabine |
Inclusion Criteria: 1. Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted. 3. Patient is willing and able to adhere to the study visit schedule...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Soligenix, Inc. | SNGX | 1 | PHASE3 | Hypericin |
| Incyte Corporation | INCY | 2 | PHASE2 | Ruxolitinib, Pembrolizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | — | Undisclosed |