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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01139151 | 4'-Thio-araC (Thiarabine) in Advanced Hematologic Malignancies | PHASE1 | COMPLETED | 31 | — | — | Aug 1, 2010 | Nov 1, 2013 | Jun 17, 2014 | 1 | United States |
The MTD is the highest dose level in which \<2 patients of six develop first cycle dose-limiting toxicity (DLT).
| Arm | Type | Description |
|---|---|---|
| Group 1 - 3 Day Thiarabine | EXPERIMENTAL | Thiarabine 3 days in a row in each cycle. |
| Group 2 - 5 Day Thiarabine | EXPERIMENTAL | Thiarabine 5 days a row in each cycle. |
| Name | Type | Description |
|---|---|---|
| 3 Day Thiarabine | DRUG | Starting dose 70 mg/m\^2 IV over 1 hour (±15 minutes) daily x 3 |
| 5 Day Thiarabine | DRUG | Starting dose 40 mg/m2 IV over 1 hour (±15 minutes) daily x 5 |
Inclusion Criteria: 1. Patients must have relapsed/refractory leukemias for which no standard therapies are anticipated to result in a durable remission. Patients with poor-risk myelodysplasia (MDS) \[i.e. refractory anemia with excess blasts (RAEB-1 or RAEB-2) by WHO classification\] and chronic m...