Leukemia, Lymphocytic, Chronic
Conditions
Keywords
CLL, PLL, flavopiridol
Brief summary
Multicenter, open-label, study of alvocidib in previously treated chronic lymphocytic leukemia patients. Primary objective is to determine overall response rate. The secondary objectives are: * to assess overall safety, * to assess duration of response, progression free survival, and overall survival. Clinical benefit and pharmacokinetics parameters are also evaluated.
Detailed description
Treatment until disease progression or no evidence of treatment response; occurrence of unacceptable toxicity, intercurrent medical problem, or adverse event (AE); or a maximum of 6 cycles. Follow-up of 6 months after the last treatment with alvocidib. The maximum duration of the study participation for patient will be about 15 months.
Interventions
DRUGalvocidib
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.
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 be fludarabine refractory; * Patient must have the adequate organ functions; * Patient's Eastern Cooperative Oncology Group performance (ECOG) status must be 0-2;
Exclusion criteria
* Patient with de novo PLL; * Patient with secondary malignancy that will limit survival ≤5 years; * Patient with prior allogenic or autologous bone marrow transplant or peripheral blood stem cell transplant ≤12 months; * Patient receiving an investigational agent or an approved agent for an investigational purpose within last 4 weeks prior to study entry; * Patient with known history of glucose-6-phosphate dehydrogenase deficiency; * Patient with autoimmune hemolytic anemia; * Patient with known Central Nervous System involvement; * Patient with active, uncontrolled serious bacterial, viral or fungal infections The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best overall objective response rate | Up to a maximum of 6 cycles | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | Up to a maximum of 6 cycles | Progression-free survival (PFS) is defined as the time from the date of first administration of study drug to the first documentation of progressive disease or death due to any cause in the absence of previous documentation of objective progression. |
| Duration of objective response | Up to a maximum of 6 cycles | Duration of objective response is defined from the time of first occurrence of complete response or partial response (including nodular partial response) to the first documentation of progressive disease or death due to any cause in the absence of previous documentation of objective progression. |
| Overall survival | Up to a maximum of 6 cycles | Overall survival (OS) is defined as the time from the date of first administration of study drug to death. |
| Overview of adverse events | from study drug administration up to 30 days after last study drug administration | — |
Countries
Australia, Belgium, France, Germany, Italy, Netherlands, Puerto Rico, United Kingdom, United States
Outcome results
None listed