Evaluation of the Safety and Efficacy of Nipent, Cytoxan, and Rituxan
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: Cytoxan; Nipent; Rituxan
Intervention description: 600 mg/m^2 on Day 1 of 21-day cycle.; 4 mg/m^2 on Day 1 of 21 Day Cycle.; 375 mg/m^2 on Day 1 of 21 Day Cycle.
Intervention MeSH terms: Cyclophosphamide; Rituximab; Pentostatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Hodgkin's Lymphoma; NHL; Lymphoma; B-cell chronic lymphocytic leukemia; SLL; Small Lymphocytic Lymphoma; Lymphoplasmacytic lymphoma/immunocytoma; Follicular lymphoma; Extranodal marginal zone B-cell lymphoma of MALT type; Nodal marginal zone B-cell lymphoma; Chronic Lymphocytic Leukemia; CLL; Bulky Lymphoma; Nipent; Cytoxan; Rituxan; Cyclophosphamide; Rituximab; Pentostatin

Summary:

      The goal of the clinical research study is to learn if treatment with a combination of three
      drugs, Cytoxan (cyclophosphamide), Rituxan (rituximab) and Nipent (pentostatin), will help to
      control the disease in patients with previously untreated non-Hodgkin's lymphoma, CLL, or
      bulky lymphoma. The safety of this treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically proven, stage III or IV, low-grade B-cell NHL, as
             defined by the updated WHO modification of the REAL classification for peripheral
             B-cell neoplasms: B-cell chronic lymphocytic leukemia/small lymphocytic lymphoma;
             Lymphoplasmacytic lymphoma/immunocytoma; Follicular lymphoma; Extranodal marginal zone
             B-cell lymphoma of MALT type; Nodal marginal zone B-cell lymphoma (+/- monocytoid
             B-cells); Lymphoma with primarily bone marrow-only disease are considered eligible

          2. Bulky lymphoma or Stage II disease requiring chemotherapy will be considered for
             enrollment with documented Sponsor Investigator approval prior to registration.

          3. CT or MRI scans confirming measurable tumor size (lymph node must be >1cm in its
             longest transverse diameter). Measurement by physical exam is acceptable in the case
             of palpable and reproducibly measurable axillary or other superficial tumors.

          4. Positive expression of cluster of differentiation antigen 20 (CD20) by biopsy or
             circulating lymphocytes.

          5. Zero or one prior chemotherapeutic or immunotherapeutic treatment regimen for B-cell
             NHL.

          6. Male or female greater than or equal to 18 years of age.

          7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

          8. Adequate renal function: Creatinine less than 1.5 mg/dL; blood urea nitrogen (BUN)
             less than 30 mg/dL or a creatinine clearance greater than or equal to 60 mL/min based
             on calculation of creatinine clearance using the Cockcroft-Gault method or from a
             24-hour urine collection. Creatinine clearance 40- 59 mL/min from a 24-hour urine
             collection would require a Nipent dose reduction of 25%. Patients with a Creatinine
             clearance <40 mL/min from a 24-hour urine collection will be excluded.

          9. Adequate bone marrow function: absolute neutrophil count (ANC) greater than or equal
             to 1,000 cells/µL; Platelet count greater than or equal to 75,000 cells/µL; Hemoglobin
             greater than or equal to 9 g/dL. Patients with idiopathic thrombocytopenia or
             autoimmune hemolytic anemia are eligible with prior approval of Sponsor Investigator.

         10. Adequate liver function: Bilirubin less than or equal to 2.0 mg/dL; AST and ALT less
             than or equal to 5 times upper limit of normal (ULN).

         11. Adequate cardiac function in the judgment of the Investigator, including New York
             Heart Association (NYHA) classification of I or II.

         12. Female patients of childbearing potential must have a negative serum pregnancy test
             within 7 days prior to registration.

         13. Patient agrees to use an acceptable method of birth control, if fertile patient (male
             or female), to avoid pregnancy for the duration of the study and for at least 3 months
             thereafter.

         14. Completed Patient Informed Consent Form.

        Exclusion Criteria:

          1. Previous or current intermediate or high-grade lymphoma.

          2. White blood cell count (WBC) greater than 30,000 cells/µL.

          3. Received prior therapy using Rituxan, unless such therapy was completed at least 6
             months prior to study registration. Patients whose disease was non-responsive to prior
             Rituxan therapy will be excluded.

          4. Known sensitivity to Nipent, Rituxan, Cytoxan or any component of these drugs.

          5. Patient received replacement steroid therapy less than 4 weeks prior to study
             registration.

          6. History of other malignancy that could affect the diagnosis or assessment of the study
             treatment.

          7. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
             illness.

          8. Known prior history of and/or active viral hepatitis (HBV or HCV).

          9. Patient is unable to comply with the requirements of this study.

         10. Patients with Richter's transformation will be excluded.