Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as HMR1275
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 chronic lymphocytic leukemia, including prolymphocytic leukemia arising from CLL. It has been tested in patients who were previously treated for these conditions. It is not an approved therapy and remains in clinical development for this indication.
Alvocidib is a cyclin-dependent kinase inhibitor that targets CDK1, CDK2, CDK4, CDK6, CDK7, and CDK9. By inhibiting these CDKs, it interferes with cell cycle progression and transcriptional regulation in cancer cells. This multi-CDK inhibition profile is the basis for its study in hematologic malignancies such as chronic lymphocytic leukemia.
Alvocidib is being developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor associated with the clinical program evaluating alvocidib in chronic lymphocytic leukemia and related prolymphocytic leukemia. The drug is a small molecule in the oncology therapeutic area.
Alvocidib is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA for chronic lymphocytic leukemia or any other indication. The Phase 2 study evaluating it in previously treated CLL has been completed.
Alvocidib has been evaluated in the Phase 2 trial NCT00464633, titled Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia. The study enrolled 165 patients across the United States, Australia, Belgium, France, Germany, Italy, the Netherlands, Puerto Rico, and the United Kingdom, and it is now completed.
The Phase 2 trial NCT00464633 was an uncontrolled, non-randomized, open-label study of alvocidib in 165 patients aged 18 years and older with previously treated chronic lymphocytic leukemia or prolymphocytic leukemia arising from CLL. It enrolled both male and female patients and did not use healthy volunteers. The trial is completed.