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

NCT00464633 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2013-02-12

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

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

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00464633 on ClinicalTrials.gov