Clinical trial NCT00464633: Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL)
Official title: A Multicenter, Open-label, Single Arm Study of Weekly Alvocidib in Patients With Previously Treated B-Cell Chronic Lymphocytic Leukemia (CLL) or Prolymphocytic Leukemia (PLL) Arising From CLL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia, Lymphocytic, Chronic
Keywords: CLL
PLL
flavopiridol
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-04-23
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Best overall objective response rate
timeFrame: Up to a maximum of 6 cycles
Secondary outcomes:
measure: Progression-free survival
timeFrame: Up to a maximum of 6 cycles
measure: Duration of objective response
timeFrame: Up to a maximum of 6 cycles
measure: Overall survival
timeFrame: Up to a maximum of 6 cycles
measure: Overview of adverse events
timeFrame: from study drug administration up to 30 days after last study drug administration
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sanofi-Aventis Investigational Site Number 840008
state: California
city: San Francisco
country: United States
facility: Sanofi-Aventis Investigational Site Number 840022
state: California
city: Chicago
country: United States
facility: Sanofi-Aventis Investigational Site Number 840010
state: Illinois
city: Chicago
country: United States
facility: Sanofi-Aventis Investigational Site Number 840012
state: Illinois
city: Indianapolis
country: United States
facility: Sanofi-Aventis Investigational Site Number 840017
state: Indiana
city: Boston
country: United States
facility: Sanofi-Aventis Investigational Site Number 840001
state: Massachusetts
city: Ann Arbor
country: United States
facility: Sanofi-Aventis Investigational Site Number 840023
state: Michigan
city: New York
country: United States
facility: Sanofi-Aventis Investigational Site Number 840005
state: New York
city: New York
country: United States
facility: Sanofi-Aventis Investigational Site Number 840006
state: New York
city: Durham
country: United States
facility: Sanofi-Aventis Investigational Site Number 840003
state: North Carolina
city: Cleveland
country: United States
facility: Sanofi-Aventis Investigational Site Number 840018
state: Ohio
city: Columbus
country: United States
facility: Sanofi-Aventis Investigational Site Number 840002
state: Ohio
city: Philadelphia
country: United States
facility: Sanofi-Aventis Investigational Site Number 840020
state: Pennsylvania
city: St Leonards
country: Australia
facility: Sanofi-Aventis Investigational Site Number 036001
city: Brugge
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056006
city: Bruxelles
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056001
city: Gent
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056004
city: Leuven
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056003
city: Yvoir
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056002
city: Paris Cedex 13
country: France
facility: Sanofi-Aventis Investigational Site Number 250001
city: Pierre Benite Cedex
country: France
facility: Sanofi-Aventis Investigational Site Number 250003
city: Tours
country: France
facility: Sanofi-Aventis Investigational Site Number 250002
city: Kiel
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276004
city: Köln
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276001
city: Ulm
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276002
city: Bologna
country: Italy
facility: Sanofi-Aventis Investigational Site Number 380002
city: Milano
country: Italy
facility: Sanofi-Aventis Investigational Site Number 380001
city: Amsterdam
country: Netherlands
facility: Sanofi-Aventis Investigational Site Number 528003
city: Groningen
country: Netherlands
facility: Sanofi-Aventis Investigational Site Number 528001
city: Rotterdam
country: Netherlands
facility: Sanofi-Aventis Investigational Site Number 528002
city: San Juan
country: Puerto Rico
facility: Sanofi-Aventis Investigational Site Number 630001
city: Aberdeen
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826005
city: Birmingham
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826002
city: Bournemouth
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826004
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: