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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01551524 | Phase I Study of mPEG-R-Crisantaspase Given IV | PHASE1 | COMPLETED | 36 | — | — | Mar 1, 2012 | Feb 1, 2015 | May 7, 2015 | 5 | France |
To determine the Maximum Tolerated Dose following one single dose of mPEG-r-Crisantaspase when administered in a population of patients with relapsed or refractory hematological malignancies, as measured by Dose Limiting Toxicities.
| Arm | Type | Description |
|---|---|---|
| Intravenous Erwinia | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| mPEG-r-crisantaspase | BIOLOGICAL | IV infusion over 60 minutes of mPEG-r-crisantaspase given once every two or four weeks for two administrations. Based on non-clinical data, 500IU/m2 has been selected as the starting dose. Dose selection will proceed based upon safety and pharmacokinetic data but escalation will not exceed 100% |
Inclusion Criteria: * Patients with any relapsed or refractory hematological malignancy, for which standard curative or life prolonging treatment does not exist, or is no longer effective or tolerable. * For the following hematological malignancies, patients must have received at least: * Low gr...