Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia
Condition: B-cell Chronic Lymphocytic Leukemia; Prolymphocytic Leukemia; Refractory Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Prolymphocytic
Intervention: alvocidib
Intervention MeSH terms: Alvocidib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well flavopiridol works in treating patients with chronic
      lymphocytic leukemia or prolymphocytic leukemia. Drugs used in chemotherapy, such as
      flavopiridol, work in different ways to stop the growth of cancer cells, either by killing
      the cells or by stopping them from dividing
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed B-cell chronic lymphocytic leukemia (CLL) or prolymphocytic
             leukemia (PLL) arising from CLL

               -  No de novo PLL

               -  Lymphocyte count > 5,000/mm^3 at some point since initial diagnosis of CLL

               -  B-cells co-expressing CD5 AND CD19 or CD20

               -  If no dim serum immunoglobulin or CD23 expression on leukemia cells, must be
                  examined for cyclin D1 overexpression OR t(11;14) to rule out mantle cell
                  lymphoma

          -  Requiring therapy, defined by any of the following:

               -  Massive or progressive splenomegaly and/or lymphadenopathy

               -  Anemia (hemoglobin < 11 g/dL) OR thrombocytopenia (platelet count < 100,000/mm^3)

               -  Weight loss > 10% within the past 6 months

               -  Grade 2 or 3 fatigue

               -  Fevers > 100.5°C or night sweats for > 2 weeks with no evidence of infection

               -  Progressive lymphocytosis with an increase of > 50% over a 2-month period OR an
                  anticipated doubling time < 6 months

          -  Received ≥ 1 prior chemotherapy regimen that included fludarabine or nucleoside
             equivalent OR alternative therapy if contraindication to fludarabine exists (i.e.,
             autoimmune hemolytic anemia)

          -  Performance status - ECOG 0-2

          -  More than 2 years

          -  See Disease Characteristics

          -  Baseline cytopenias allowed

          -  WBC ≤ 200,000/mm^3

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to Gilbert's disease,
             hemolysis, or disease infiltration of the liver)

          -  AST ≤ 2 times ULN (unless due to hemolysis or disease infiltration of the liver)

          -  Creatinine ≤ 2.0 mg/dL

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No other malignancy that would limit life expectancy

          -  See Disease Characteristics

          -  No other concurrent chemotherapy

          -  No concurrent chronic corticosteroids or corticosteroids as antiemetics

          -  No concurrent hormonal therapy except steroids for new adrenal failure or hormones for
             nondisease-related conditions (e.g., insulin for diabetes)

          -  No concurrent radiotherapy