Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT01076556
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed chronic lymphocytic leukemia (CLL) or B-cell prolymphocytic leukemia\* (PLL) arising from CLL
* Patients must have documented B-cell lymphocytosis \> 5 x 10\^9/L at some point since initial diagnosis of CLL
* Patients must have B-cells that co-express CD5 with CD19 or CD20
* Patients who do not have dim sIg or CD23 expression on their leukemia cells should be examined for cyclin D1 over-expression or t(11;14) to rule out mantle cell lymphoma
* To be considered high risk, patients must meet the following criteria:
* At least 1 of the following:
* 17p deletion
* 11q deletion
* Un-mutated IgV\_H (≥ 98% homology)
* Age \> 70 years
* B\_2M \> 4
* AND at least 1 of the following:
* Progressive or marked splenomegaly and/or lymphadenopathy
* Anemia (hemoglobin \< 11 g/dL) or thrombocytopenia (platelets \< 100,000/mm\^3)
* Weight loss exceeding 10% of body weight over preceding 6 months
* NCI grade 2 or 3 fatigue
* Fevers \> 100.5° F or night sweats for \> 2 weeks without evidence of infection
* Progressive lymphocytosis, with an increase exceeding 50% over a 2-month period or a doubling time of \< 6 months
* No other concurrent hormones, chemotherapy, or radiotherapy except for steroids for new adrenal failure or hormones for nondisease-related conditions (e.g., insulin for diabetes)
* No requirement for chronic corticosteroids
* ECOG performance status 0-2
* Creatinine ≤ 2.0 mg/dL
* Bilirubin ≤ 1.5 times normal unless due to Gilbert disease, hemolysis, or disease infiltration of the liver
* AST ≤ 2 times normal unless due to hemolysis or disease infiltration of the liver
* Negative pregnancy test
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No secondary or other malignancy that will limit survival to \< 2 years
* No uncontrolled concurrent illness including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness or social situations that would limit compliance with study requirements
* No uncompensated HIV without adequate CD4 (\> 200/mm\^3) and requiring HIV medication
* No active hepatitis B infection
* No known G6PD deficiency
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to alvocidib, cyclophosphamide, rituximab, or other agents used in this study
* No prior alvocidib
* No prior purine analog therapy
* No more than 1 prior treatment with a biologic or alkylating agent
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01076556
Study Brief:
Protocol Section:
NCT01076556