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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00464633
First received: April 20, 2007
Last updated: February 8, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Leukemia, Lymphocytic, Chronic
Drug: alvocidib
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Best overall objective response rate [ Time Frame: Up to a maximum of 6 cycles ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Up to a maximum of 6 cycles ] [ Designated as safety issue: No ]
    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.

  • Duration of objective response [ Time Frame: Up to a maximum of 6 cycles ] [ Designated as safety issue: No ]
    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.

  • Overall survival [ Time Frame: Up to a maximum of 6 cycles ] [ Designated as safety issue: No ]
    Overall survival (OS) is defined as the time from the date of first administration of study drug to death.

  • Overview of adverse events [ Time Frame: from study drug administration up to 30 days after last study drug administration ] [ Designated as safety issue: Yes ]

Enrollment: 165
Study Start Date: March 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alvocidib
Cycles with 4-week treatment with alvocidib followed by 2-week rest period for up to a maximum of 6 cycles
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.
Other Name: HMR1275

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464633

  Show 34 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00464633     History of Changes
Other Study ID Numbers: EFC6663, 2006-006152-34
Study First Received: April 20, 2007
Last Updated: February 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
CLL
PLL
flavopiridol

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia, Prolymphocytic
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Alvocidib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Growth Inhibitors
Growth Substances
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014