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.
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.
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 34 Locations for this study
San Diego California, 92103, United States
San Francisco California, 94143, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Indianapolis Indiana, 46202, United States
Boston Massachusetts, 02115, United States
Ann Arbor Michigan, 48109, United States
New York New York, 10021, United States
New York New York, 10029, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43210, United States
Philadelphia Pennsylvania, 19104, United States
St Leonards , 2065, Australia
Brugge , 8000, Belgium
Bruxelles , 1000, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Yvoir , 5530, Belgium
Paris Cedex 13 , 75651, France
Pierre Benite Cedex , 69495, France
Tours , 37044, France
Kiel , 24116, Germany
Köln , 50937, Germany
Ulm , 89081, Germany
Bologna , 40138, Italy
Milano , 20132, Italy
Amsterdam , 1081 , Netherlands
Groningen , 9713 , Netherlands
Rotterdam , 3015 , Netherlands
San Juan , 00927, Puerto Rico
Aberdeen , AB25 , United Kingdom
Birmingham , B9 5S, United Kingdom
Bournemouth , BH7 7, United Kingdom
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.