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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00890500 | Safety and Efficacy of ProHema Modulated Umbilical Cord Blood Units in Subjects With Hematologic Malignancies. | PHASE1 | COMPLETED | 12 | — | — | Jan 1, 2011 | Oct 1, 2013 | Oct 8, 2013 | 2 | United States |
| Arm | Type | Description |
|---|---|---|
| Group 1 | ACTIVE_COMPARATOR | 2 umbilical cord units: Second cord blood unit modulated with ProHema |
| Group 2 | ACTIVE_COMPARATOR | 2 umbilical cord units: First cord blood unit modulated with ProHema |
| Name | Type | Description |
|---|---|---|
| Fludarabine | DRUG | 30mg/m2/day IV x 6 days |
| Melphalan | DRUG | 100 mg/m2/day IV x 1 day |
| Antithymocyte Globulin | DRUG | 1mg/kg/day x 4 days |
| Sirolimus | DRUG | GVHD Prophylaxis: Target range 3-12 ng/ml |
| Tacrolimus | DRUG | GVHD Prophylaxis: Target range 5-10 ng/ml |
Inclusion Criteria: * Patients with hematologic malignancies for whom allogeneic stem cell transplantation is deemed clinically appropriate * Patient must be ineligible for traditional myeloablative transplantation according to treating physician * Lack of 6/6 or 5/6 HLA-matched related, 8/8 HLA-ma...