Evaluation of the Safety and Efficacy of Nipent, Cytoxan, and Rituxan

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: Astex Pharmaceuticals; Astex Pharmaceuticals, Inc.; Pharmatech
• Treatments: Cyclophosphamide; Pentostatin; Rituximab

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.