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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00502112 | A Phase I Study of Lintuzumab Combined With Lenalidomide in Patients With Myelodysplastic Syndromes (MDS) | PHASE1 | COMPLETED | 13 | — | — | Mar 1, 2008 | May 1, 2010 | Oct 12, 2011 | 8 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | lintuzumab and lenalidomide |
| Name | Type | Description |
|---|---|---|
| lintuzumab | DRUG | 4 or 8 mg/kg IV (in the vein) on Days 1, 8 and 15 for the first 21-day cycle; 4 or 8 mg/kg IV (in the vein) on Days 1 and 8 for the second through the eighth 21-day cycle |
| lenalidomide | DRUG | 10 or 15 mg per day, taken orally on Days 1-14 of each 21-day cycle |
Inclusion Criteria: 1. Disease confirmation of MDS. 2. Between 5% and 30% blasts in the bone marrow. 3. Received treatment for cytopenias within 2-months 4. ECOG ≤ 2. Exclusion Criteria: 1. Received prior therapy with lenalidomide, gemtuzumab ozogamicin (Mylotarg®). 2. Received chemotherapy/radio...