Status:
COMPLETED
Pentostatin, Alemtuzumab, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as pentostatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibod...
Detailed Description
OBJECTIVES: Primary * To assess the rate of complete and overall response in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma treated with pentostatin,...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) meeting the following criteria:
- Minimum threshold peripheral blood lymphocyte count of 5 x 10\^9/L (CLL variant) OR adenopathy \> 1 cm or palpable splenomegaly (SLL variant)
- Immunophenotypic demonstrations of a population of B lymphocytes (as defined by CD19+) that are monoclonal (by light chain exclusion) AND have ≥ 3 of the following characteristics:
- CD5+
- CD23+
- Dim surface light chain expression
- Dim surface CD20 expression
- FISH analysis is negative for IGH/CCND1 and/or immunostaining is negative for cyclin D1 expression
- Must have progressive disease as indicated by any of the following characteristics (based on standard criteria for treatment):
- Symptomatic CLL characterized by any of the following:
- Weight loss \> 10% within the past 6 months
- Extreme fatigue
- Fevers \> 38.5° C (not due to infection)
- Drenching night sweats without evidence of infection
- Evidence of progressive bone marrow failure with hemoglobin \< 11 g/dL or platelet count \< 100 x 10\^9/L
- Massive and progressive splenomegaly (\> 6 cm below left costal margin)
- Massive (\> 10 cm) or rapidly progressive lymphadenopathy
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-3
- Creatinine ≤ 2 times upper limit of normal (ULN)
- Total bilirubin ≤ 3.0 times ULN OR direct bilirubin ≤ 1.5 times ULN
- AST ≤ 3.0 times ULN (unless due to hemolysis or CLL)
- Willing to provide mandatory blood samples for research studies
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for up to 12 months after completion of study treatment
- No other active primary malignancy that requires treatment or limits survival to ≤ 2 years
- No active autoimmune hemolytic anemia, immune thrombocytopenia, or pure red blood cell aplasia
- No New York Heart Association class III or IV heart disease
- No myocardial infarction within the past month
- No uncontrolled infection
- No HIV infection or AIDS
- No active hepatitis B infection (i.e., HBsAg or HBeAg positivity) or hepatitis C infection by serology
- No other comorbid condition
- PRIOR CONCURRENT THERAPY:
- No more than 3 prior treatment regimens for CLL that included purine analogue drugs (e.g., fludarabine, pentostatin, or cladribine) OR previously untreated CLL in patients with high-risk disease due to 17p13 deletion on FISH analysis
- More than 4 weeks since prior major surgery
- More than 2 months since prior alemtuzumab
- Prior corticosteroids allowed
- No concurrent continuous systemic corticosteroids
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00669318
Start Date
July 1 2008
End Date
May 1 2014
Last Update
July 1 2014
Active Locations (3)
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1
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908