Chronic Lymphocytic Leukemia Clinical Trial

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

Summary

Multicenter, open-label, study of alvocidib in previously treated leukemia-cll/" >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.

View Full Description

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.

View Eligibility Criteria

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.

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

165

Study ID:

NCT00464633

Recruitment Status:

Completed

Sponsor:

Sanofi

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 34 Locations for this study

See Locations Near You

Sanofi-Aventis Investigational Site Number 840008
San Diego California, 92103, United States
Sanofi-Aventis Investigational Site Number 840022
San Francisco California, 94143, United States
Sanofi-Aventis Investigational Site Number 840010
Chicago Illinois, 60611, United States
Sanofi-Aventis Investigational Site Number 840012
Chicago Illinois, 60637, United States
Sanofi-Aventis Investigational Site Number 840017
Indianapolis Indiana, 46202, United States
Sanofi-Aventis Investigational Site Number 840001
Boston Massachusetts, 02115, United States
Sanofi-Aventis Investigational Site Number 840023
Ann Arbor Michigan, 48109, United States
Sanofi-Aventis Investigational Site Number 840005
New York New York, 10021, United States
Sanofi-Aventis Investigational Site Number 840006
New York New York, 10029, United States
Sanofi-Aventis Investigational Site Number 840003
Durham North Carolina, 27710, United States
Sanofi-Aventis Investigational Site Number 840018
Cleveland Ohio, 44106, United States
Sanofi-Aventis Investigational Site Number 840002
Columbus Ohio, 43210, United States
Sanofi-Aventis Investigational Site Number 840020
Philadelphia Pennsylvania, 19104, United States
Sanofi-Aventis Investigational Site Number 036001
St Leonards , 2065, Australia
Sanofi-Aventis Investigational Site Number 056006
Brugge , 8000, Belgium
Sanofi-Aventis Investigational Site Number 056001
Bruxelles , 1000, Belgium
Sanofi-Aventis Investigational Site Number 056004
Gent , 9000, Belgium
Sanofi-Aventis Investigational Site Number 056003
Leuven , 3000, Belgium
Sanofi-Aventis Investigational Site Number 056002
Yvoir , 5530, Belgium
Sanofi-Aventis Investigational Site Number 250001
Paris Cedex 13 , 75651, France
Sanofi-Aventis Investigational Site Number 250003
Pierre Benite Cedex , 69495, France
Sanofi-Aventis Investigational Site Number 250002
Tours , 37044, France
Sanofi-Aventis Investigational Site Number 276004
Kiel , 24116, Germany
Sanofi-Aventis Investigational Site Number 276001
Köln , 50937, Germany
Sanofi-Aventis Investigational Site Number 276002
Ulm , 89081, Germany
Sanofi-Aventis Investigational Site Number 380002
Bologna , 40138, Italy
Sanofi-Aventis Investigational Site Number 380001
Milano , 20132, Italy
Sanofi-Aventis Investigational Site Number 528003
Amsterdam , 1081 , Netherlands
Sanofi-Aventis Investigational Site Number 528001
Groningen , 9713 , Netherlands
Sanofi-Aventis Investigational Site Number 528002
Rotterdam , 3015 , Netherlands
Sanofi-Aventis Investigational Site Number 630001
San Juan , 00927, Puerto Rico
Sanofi-Aventis Investigational Site Number 826005
Aberdeen , AB25 , United Kingdom
Sanofi-Aventis Investigational Site Number 826002
Birmingham , B9 5S, United Kingdom
Sanofi-Aventis Investigational Site Number 826004
Bournemouth , BH7 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

165

Study ID:

NCT00464633

Recruitment Status:

Completed

Sponsor:


Sanofi

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider