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

NCT00464633 | Completed Phase 2 DMC

• 2 other identifiers: EFC66632006-006152-34
• Study Type: interventional
• Target: 165
• Locations: 9 countries
• Sites: 34

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.

Conditions

Leukemia, Lymphocytic, Chronic

Keywords

CLL; PLL; flavopiridol

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Progression-free survival

  Up to a maximum of 6 cycles

• Duration of objective response

  Up to a maximum of 6 cycles

• Overall survival

  Up to a maximum of 6 cycles

• Overview of adverse events

  from study drug administration up to 30 days after last study drug administration

Study Arms (1)

Alvocidib

EXPERIMENTAL

Cycles with 4-week treatment with alvocidib followed by 2-week rest period for up to a maximum of 6 cycles

Drug: alvocidib

Interventions

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.

Also known as: HMR1275

Alvocidib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (34)

Sanofi-Aventis Investigational Site Number 840008

San Diego, California, 92103, United States

Location

Sanofi-Aventis Investigational Site Number 840022

San Francisco, California, 94143, United States

Location

Sanofi-Aventis Investigational Site Number 840010

Chicago, Illinois, 60611, United States

Location

Sanofi-Aventis Investigational Site Number 840012

Chicago, Illinois, 60637, United States

Location

Sanofi-Aventis Investigational Site Number 840017

Indianapolis, Indiana, 46202, United States

Location

Sanofi-Aventis Investigational Site Number 840001

Boston, Massachusetts, 02115, United States

Location

Sanofi-Aventis Investigational Site Number 840023

Ann Arbor, Michigan, 48109-0759, United States

Location

Sanofi-Aventis Investigational Site Number 840005

New York, New York, 10021, United States

Location

Sanofi-Aventis Investigational Site Number 840006

New York, New York, 10029-6574, United States

Location

Sanofi-Aventis Investigational Site Number 840003

Durham, North Carolina, 27710, United States

Location

Sanofi-Aventis Investigational Site Number 840018

Cleveland, Ohio, 44106, United States

Location

Sanofi-Aventis Investigational Site Number 840002

Columbus, Ohio, 43210, United States

Location

Sanofi-Aventis Investigational Site Number 840020

Philadelphia, Pennsylvania, 19104, United States

Location

Sanofi-Aventis Investigational Site Number 036001

St Leonards, 2065, Australia

Location

Sanofi-Aventis Investigational Site Number 056006

Bruges, 8000, Belgium

Location

Sanofi-Aventis Investigational Site Number 056001

Brussels, 1000, Belgium

Location

Sanofi-Aventis Investigational Site Number 056004

Ghent, 9000, Belgium

Location

Sanofi-Aventis Investigational Site Number 056003

Leuven, 3000, Belgium

Location

Sanofi-Aventis Investigational Site Number 056002

Yvoir, 5530, Belgium

Location

Sanofi-Aventis Investigational Site Number 250001

Paris, 75651, France

Location

Sanofi-Aventis Investigational Site Number 250003

Pierre-Bénite, 69495, France

Location

Sanofi-Aventis Investigational Site Number 250002

Tours, 37044, France

Location

Sanofi-Aventis Investigational Site Number 276001

Cologne, 50937, Germany

Location

Sanofi-Aventis Investigational Site Number 276004

Kiel, 24116, Germany

Location

Sanofi-Aventis Investigational Site Number 276002

Ulm, 89081, Germany

Location

Sanofi-Aventis Investigational Site Number 380002

Bologna, 40138, Italy

Location

Sanofi-Aventis Investigational Site Number 380001

Milan, 20132, Italy

Location

Sanofi-Aventis Investigational Site Number 528003

Amsterdam, 1081 HV, Netherlands

Location

Sanofi-Aventis Investigational Site Number 528001

Groningen, 9713 GZ, Netherlands

Location

Sanofi-Aventis Investigational Site Number 528002

Rotterdam, 3015 CE, Netherlands

Location

Sanofi-Aventis Investigational Site Number 630001

San Juan, 00927, Puerto Rico

Location

Sanofi-Aventis Investigational Site Number 826005

Aberdeen, AB25 2ZN, United Kingdom

Location

Sanofi-Aventis Investigational Site Number 826002

Birmingham, B9 5SS, United Kingdom

Location

Sanofi-Aventis Investigational Site Number 826004

Bournemouth, BH7 7DW, United Kingdom

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

alvocidib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2007
• First Posted: April 23, 2007
• Study Start: March 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 12, 2013

Record last verified: 2013-02

Locations

AU (1); FR (3); BE (5); IT (2); GB (3); US (13); DE (3); NL (3); PR (1)