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COMPLETEDPHASE2

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

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

NCT00464633•Sanofi

View on ClinicalTrials.gov

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.

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (34)

Sanofi-Aventis Investigational Site Number 840008

San Diego, California, United States

Sanofi-Aventis Investigational Site Number 840022

San Francisco, California, United States

Sanofi-Aventis Investigational Site Number 840010

Chicago, Illinois, United States

Sanofi-Aventis Investigational Site Number 840012

Chicago, Illinois, United States

Sanofi-Aventis Investigational Site Number 840017

Indianapolis, Indiana, United States

Sanofi-Aventis Investigational Site Number 840001

Boston, Massachusetts, United States

Sanofi-Aventis Investigational Site Number 840023

Ann Arbor, Michigan, United States

Sanofi-Aventis Investigational Site Number 840005

New York, New York, United States

Sanofi-Aventis Investigational Site Number 840006

New York, New York, United States

Sanofi-Aventis Investigational Site Number 840003

Durham, North Carolina, United States

Key Dates

Start Date

March 1, 2007

Primary Completion Date

December 1, 2011

Completion Date

December 1, 2011

Last Updated

February 12, 2013

Enrollment

165

ACTUAL participants

Conditions

Leukemia, Lymphocytic, Chronic

Interventions

alvocidib

DRUG

Long-Term Safety of Pirtobrutinib in Participants With Previously Treated Types of Blood Cancers

NCT07162181

Lymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-Cell+1 more

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COMPLETEDPHASE1

A Study of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

NCT04210219

Lymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-Cell

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Long-Term Safety of Pirtobrutinib in Participants With Previously Treated Types of Blood Cancers

A Study of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

A Study to Assess Safety of ImbruvicaTM in Indian Participants With Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy or Chronic Lymphocytic Leukemia With 17p Deletion

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A Study of Ibrutinib in the Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice

A Phase 1/2, Open-label, Dose Finding Study to Evaluate CC-122 in Combination With Ibrutinib and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma