Status:
TERMINATED
Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
B-cell Chronic Lymphocytic Leukemia
Prolymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the complete response (CR) and overall response rate (CR + Partial Response \[PR\]) of this regimen. II. To assess the toxicity profile of this regimen. III. To e...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00098371
Start Date
April 1 2005
End Date
November 1 2012
Last Update
October 24 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210