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

Leukemia, Lymphocytic, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00464633
• Other study ID #: EFC6663
• Secondary ID: 2006-006152-34
• Status: Completed
• Phase: Phase 2
• First received: April 20, 2007
• Last updated: February 8, 2013
• Start date: March 2007
• Est. completion date: December 2011

Study information

• Verified date: February 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Leukemia, Prolymphocytic

Intervention

Drug:
• alvocidib
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.

Locations

Country	Name	City	State
Australia	Sanofi-Aventis Investigational Site Number 036001	St Leonards
Belgium	Sanofi-Aventis Investigational Site Number 056006	Brugge
Belgium	Sanofi-Aventis Investigational Site Number 056001	Bruxelles
Belgium	Sanofi-Aventis Investigational Site Number 056004	Gent
Belgium	Sanofi-Aventis Investigational Site Number 056003	Leuven
Belgium	Sanofi-Aventis Investigational Site Number 056002	Yvoir
France	Sanofi-Aventis Investigational Site Number 250001	Paris Cedex 13
France	Sanofi-Aventis Investigational Site Number 250003	Pierre Benite Cedex
France	Sanofi-Aventis Investigational Site Number 250002	Tours
Germany	Sanofi-Aventis Investigational Site Number 276004	Kiel
Germany	Sanofi-Aventis Investigational Site Number 276001	Köln
Germany	Sanofi-Aventis Investigational Site Number 276002	Ulm
Italy	Sanofi-Aventis Investigational Site Number 380002	Bologna
Italy	Sanofi-Aventis Investigational Site Number 380001	Milano
Netherlands	Sanofi-Aventis Investigational Site Number 528003	Amsterdam
Netherlands	Sanofi-Aventis Investigational Site Number 528001	Groningen
Netherlands	Sanofi-Aventis Investigational Site Number 528002	Rotterdam
Puerto Rico	Sanofi-Aventis Investigational Site Number 630001	San Juan
United Kingdom	Sanofi-Aventis Investigational Site Number 826005	Aberdeen
United Kingdom	Sanofi-Aventis Investigational Site Number 826002	Birmingham
United Kingdom	Sanofi-Aventis Investigational Site Number 826004	Bournemouth
United States	Sanofi-Aventis Investigational Site Number 840023	Ann Arbor	Michigan
United States	Sanofi-Aventis Investigational Site Number 840001	Boston	Massachusetts
United States	Sanofi-Aventis Investigational Site Number 840010	Chicago	Illinois
United States	Sanofi-Aventis Investigational Site Number 840012	Chicago	Illinois
United States	Sanofi-Aventis Investigational Site Number 840018	Cleveland	Ohio
United States	Sanofi-Aventis Investigational Site Number 840002	Columbus	Ohio
United States	Sanofi-Aventis Investigational Site Number 840003	Durham	North Carolina
United States	Sanofi-Aventis Investigational Site Number 840017	Indianapolis	Indiana
United States	Sanofi-Aventis Investigational Site Number 840005	New York	New York
United States	Sanofi-Aventis Investigational Site Number 840006	New York	New York
United States	Sanofi-Aventis Investigational Site Number 840020	Philadelphia	Pennsylvania
United States	Sanofi-Aventis Investigational Site Number 840008	San Diego	California
United States	Sanofi-Aventis Investigational Site Number 840022	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Germany,  Italy,  Netherlands,  Puerto Rico,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best overall objective response rate	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.	Up to a maximum of 6 cycles	No
Secondary	Progression-free survival	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.	Up to a maximum of 6 cycles	No
Secondary	Duration of objective response	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.	Up to a maximum of 6 cycles	No
Secondary	Overall survival	Overall survival (OS) is defined as the time from the date of first administration of study drug to death.	Up to a maximum of 6 cycles	No
Secondary	Overview of adverse events		from study drug administration up to 30 days after last study drug administration	Yes