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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00464633 | Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL) | PHASE2 | COMPLETED | 165 | — | — | Mar 1, 2007 | Dec 1, 2011 | Feb 12, 2013 | 34 | United States, Australia +7 |
Objective Response Rate (ORR) is defined as the proportion of participants with complete response or partial response (including nodular partial response) relative to the total number of participants. Response assessment is based on evaluation of nodal disease by Computerized Tomography (CT) and National Cancer Institute Working Group 96 criteria (NCI-96) for assessment of liver, spleen, constitutional symptoms, peripheral blood (±) bone marrow.
| Arm | Type | Description |
|---|---|---|
| Alvocidib | EXPERIMENTAL | Cycles with 4-week treatment with alvocidib followed by 2-week rest period for up to a maximum of 6 cycles |
| Name | Type | Description |
|---|---|---|
| alvocidib | DRUG | 1st dose: 30 mg/m2 as a 30-minute intravenous (IV) infusion followed by 30 mg/m2 as a 4-hour continuous infusion Then, every treatment week, depending upon the patient's objective response to initial therapy: * 30 mg/m2 over 30 minutes followed by 50 mg/m2 over 4 hours or * 30 mg/m2 over 30 minutes followed by 30 mg/m2 over 4 hours. |
Inclusion Criteria: * Patient must have documentation of histologically confirmed and measurable Chronic Lymphocytic Leukemia (CLL) or Prolymphocytic Leukemia (PLL) arising from CLL; * Patient must have symptomatic and progressive disease; * Patient must have received prior alkylating agent(s) and ...