| MCCRC-RC0783 | Randomized Phase II Trial of Pentostatin, Cyclophosphamide, and Rituximab With or Without Concurrent Avastin for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL). (1670)-
Eligibility: click to view information
**Open To All Components**
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Biopsy proven small lymphocytic lymphoma (SLL)
Chronic lymphocytic leukemia (CLL)* as evidenced by the following criteria:
Peripheral blood lymphocyte count > 5,000/mm³ consisting of small to moderate size lymphocytes
Immunophenotyping consistent with CLL, defined by the following:
The predominant population of lymphocytes share both B-cell antigens (CD19, CD20, or CD23) as well as CD-5 in the absence of other pan-T-cell markers (CD-3 or CD-2)
Dim surface immunoglobulin expression
Exclusively kappa and lambda light chains
Negative FISH analysis for t(11;14)(IgH/CCND1) on peripheral blood or tissue biopsy samples NOTE: *Splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL
Has e 1 of the following indications** for chemotherapy:
Evidence of progressive marrow failure as manifested by the development of or worsening anemia (hemoglobin d 11 g/dL) and/or thrombocytopenia (platelet count d 100,000/mm³)
Symptomatic or progressive lymphadenopathy, splenomegaly or hepatomegaly
Has e 1 of the following disease-related symptoms:
Weight loss > 10% within the past 6 months
Extreme fatigue attributed to CLL
Fevers > 100.5^oF for 2 weeks without evidence of infection
Night sweats without evidence of infection
Progressive lymphocytosis (not due to the effects of corticosteroids) with an increase of > 50% over a 2-month period or an anticipated doubling time of < 6 months NOTE: **Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease are not sufficient indications for study treatment
PATIENT CHARACTERISTICS:
ECOG performance status 0-3
Life expectancy e 12 months
Total bilirubin d 3.0 times upper limit of normal (ULN) (unless due to Gilbert's disease)
Direct bilirubin < 1.5 mg/dL (in patients with Gilbert's disease)
SGOT d 3.0 times ULN (unless due to hepatic involvement by CLL)
Creatinine d 1.5 times ULN
Urine protein:creatinine ratio < 1.0 OR < 1 g of protein by 24-hour urine collection
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 12 months after completion of study treatment
Willing to provide mandatory blood and tissue samples
None of the following cardiovascular conditions:
NYHA class III-IV heart disease
Myocardial infarction within the past 6 months
Unstable angina
Stroke, cerebrovascular accident, or transient ischemic attack within the past 6 months
Arterial thromboembolic events within the past 12 months
Clinically significant peripheral vascular disease
Uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP > 100 mm Hg
Hypertension allowed provided it is controlled with a stable anti-hypertensive regimen
History of hypertensive crises or hypertensive encephalopathy
Deep venous thromboses or pulmonary embolism within the past 12 months
No evidence of bleeding diathesis or coagulopathy
No uncontrolled or active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment
No active or recent history (within the past 30 days) of hemoptysis (e ½ teaspoon of bright red blood per episode)
No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
No active peptic ulcer disease
No serious non-healing wound, ulcer, or bone fracture
No significant traumatic injury within the past 28 days
No uncontrolled infection
No active HIV infection
No other active primary malignancy (except nonmelanoma skin cancer or carcinoma in situ of the cervix) requiring treatment or limiting survival to d 2 years
No psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude study participation
PRIOR CONCURRENT THERAPY:
Prior corticosteroids allowed
More than 4 weeks since prior radiotherapy
More than 28 days since prior and no
- Consent Forms: RC0783 Consent
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