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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00495079 | Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia | PHASE2 | COMPLETED | 65 | — | — | May 1, 2007 | Aug 8, 2010 | Mar 5, 2021 | 33 | United States, Canada +3 |
CR is defined as no evidence of ALL: ANC\>or=1x10\^9/L or platelet count\>100x10\^9/L, absence of leukemia blast cells in blood and marrow (\<5% blasts), resolution of all sites of extramedullary disease (EMD). CR with incomplete blood count recovery (CRi): As per CR but platelet count\< 100x10\^9/L or ANC\< 1x10\^9/L. Partial remission(PR):CR with\>5-25% abnormal cells in the marrow or 50% decrease in bone marrow blasts. Reduction in EMD by at least 50%. Hematologic Improvement. Bone marrow blast(BMB) response: BMB\<5% in the absence of HI. Stable disease(SD):No significant hematological and extramedullary change from baseline.
Number of subjects who achieved Complete Remission (CR)as assessed by the IRRC. CR is defined as no evidence of ALL. ANC\>=1X10\^9/L or Platelet count\>=100x10\^9/L, absence of blasts in blood and morrow (\<5%), resolution of all sites of extramedullary disease (EMD). CR with incomplete blood count recovery(CRi)is defined as per CR but platelet count \<100x10\^9/L or ANC\<1x10\^9/L.
| Arm | Type | Description |
|---|---|---|
| Marqibo | EXPERIMENTAL | Eligible subjects received study drug at 2.25 mg/m\^2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes). |
| Name | Type | Description |
|---|---|---|
| Marqibo® (vincristine sulfate liposomes injection) | DRUG | Dosing was done every 7 days (± 3 days) on Days 1, 8, 15, and 22 with no less than 4 days between dosing days. Dose calculations were based on body surface area using the subject's height (from Screening) and actual weight for each course. |
Inclusion Criteria: * Age ≥18 years. * Had Ph- ALL or lymphoblastic lymphoma and was in second relapse, or had failed 2 treatment lines of anti-leukemia chemotherapy. * Had histologically or cytologically proven ALL and ≥ 10% bone marrow blasts. If \< 10% bone marrow blasts, subject must have had h...