Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
alvocidib · 1 trial · 1 indication
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 ...
Alvocidib is an investigational small molecule being studied for the treatment of chronic lymphocytic leukemia (CLL). It is being developed by Sanofi and is currently in Phase 2 clinical development for this indication.
Alvocidib is being developed by Sanofi, a global pharmaceutical company traded on the New York Stock Exchange under the ticker SNY. The drug is currently in Phase 2 clinical development for chronic lymphocytic leukemia.
Alvocidib is in Phase 2 clinical development. It is an investigational drug for chronic lymphocytic leukemia and has not been approved by regulatory authorities. One Phase 2 trial has been completed.
Alvocidib has been studied in a completed Phase 2 clinical trial with the identifier NCT00464633. This trial enrolled 165 patients with previously treated chronic lymphocytic leukemia or prolymphocytic leukemia arising from CLL.
Alvocidib is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for chronic lymphocytic leukemia. The completed Phase 2 trial (NCT00464633) evaluated its safety and efficacy in patients with previously treated CLL.