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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Lymphocytic, Chronic

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Best overall objective response rate

Outcome Description:

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.

Outcome Time Frame:

Up to a maximum of 6 cycles

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC6663

NCT ID:

NCT00464633

Start Date:

March 2007

Completion Date:

December 2011

Related Keywords:

  • Leukemia, Lymphocytic, Chronic
  • CLL
  • PLL
  • flavopiridol
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Prolymphocytic

Name

Location

Sanofi-Aventis Investigational Site Number 840008San Diego, California  92103
Sanofi-Aventis Investigational Site Number 840022San Francisco, California  94143
Sanofi-Aventis Investigational Site Number 840010Chicago, Illinois  60611
Sanofi-Aventis Investigational Site Number 840012Chicago, Illinois  60637
Sanofi-Aventis Investigational Site Number 840017Indianapolis, Indiana  46202
Sanofi-Aventis Investigational Site Number 840001Boston, Massachusetts  02115
Sanofi-Aventis Investigational Site Number 840023Ann Arbor, Michigan  48109-0759
Sanofi-Aventis Investigational Site Number 840005New York, New York  10021
Sanofi-Aventis Investigational Site Number 840006New York, New York  10029-6574
Sanofi-Aventis Investigational Site Number 840003Durham, North Carolina  27710
Sanofi-Aventis Investigational Site Number 840018Cleveland, Ohio  44106
Sanofi-Aventis Investigational Site Number 840002Columbus, Ohio  43210
Sanofi-Aventis Investigational Site Number 840020Philadelphia, Pennsylvania  19104