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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02674750 | Study to Evaluate the Efficacy and Safety of CUDC-907 in Patients With RR DLBCL, Including Patients With MYC Alterations | PHASE2 | COMPLETED | 70 | — | — | Jul 1, 2016 | May 28, 2019 | Apr 27, 2022 | 25 | United States, Spain |
Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered Diffuse Large B-Cell Lymphoma (DLBCL)
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Group A: MYC translocation+ and/or MYC gene copy number gain by FISH |
| Group B | EXPERIMENTAL | Group B: MYC expression in \> 40% of tumor cells by IHC |
| Group C | EXPERIMENTAL | Group C: MYC translocation- by FISH, and MYC expression in \< 40% of tumor cells, and no MYC gene copy number gain by FISH |
| Name | Type | Description |
|---|---|---|
| CUDC-907 | DRUG | - |
Inclusion Criteria: 1. Age ≥ 18 years. 2. At least 2 but no more than 4 prior lines of therapy for the treatment of de novo DLBCL and ineligible for (or failed) autologous or allogeneic stem cell transplant (SCT) (salvage therapy, conditioning therapy and maintenance with transplant will be conside...