Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL)

Sanofi

Status and phase

Completed

Phase 2

Conditions

Leukemia, Lymphocytic, Chronic

Treatments

Drug: alvocidib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00464633

2006-006152-34 (EudraCT Number)

EFC6663

Details and patient eligibility

About

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.

Full 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.

Enrollment

165 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.