A Phase I/II Trial of VR-CHOP in Lymphoma Patients

Inclusion Criteria

• •Tissue diagnosis of a previously untreated, cluster of differentiation antigen 20+ (CD20+), B-cell non-Hodgkin lymphoma.
• •* For the Phase 1 trial: patients with any of the following diagnoses are eligible:
• •* Follicular Lymphomas (Grade 1, 2, 3a, 3b)
• •* Small Lymphocytic Lymphoma
• •* Marginal Zone Lymphomas
• •* For the Phase 2 trial: patients with any of the following diagnoses are eligible:
• •* Follicular Lymphomas (Grade 1, 2, 3a)
• •* Small Lymphocytic Lymphoma
• •* Marginal Zone Lymphomas
• •Patients with follicular or other low-grade lymphoma must have an indication for treatment based on modified Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria or a Follicular Lymphoma International Prognostic Index (FLIPI) score ≥ 3.
• •* Indications for treatment based on modified GELF criteria include any one of the following:
• •* B symptoms or other lymphoma-related symptoms
• •* Involvement of 3 nodal sites, each with a diameter of 3 cm
• •* Any nodal or extranodal tumor mass with a diameter of 7 cm
• •* Splenomegaly greater than 16 cm by CT scan.
• •* Pleural effusions or peritoneal ascites
• •* Cytopenias (leukocytes \< 1.0 x 10 /L and/or platelets \< 100 x 10/L)
• •* Leukemia (\> 5.0 x 10 /L circulating malignant cells)
• •* Indications for treatment based on FLIPI criteria include any three of the following:
• •* Age ≥ 60 years
• •* Ann Arbor stage III or IV
• •* Hemoglobin level \< 120 g/L
• •* Number of nodal areas involved \> 4
• •* Serum lactate dehydrogenase (LDH) level \> normal
• •Only chemotherapy-naïve subjects are eligible. Subjects may have received prednisone (\< 2 months of therapy) or radiation ≤ 2 sites of therapy.
• •Voluntary written informed consent and Health Insurance Portability and Accountability Act (HIPAA) Authorization before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
• •Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
• •Female patients of child bearing potential must have a negative β-human chorionic gonadotropin (β-hCG) test.
• •Male subject agrees to use an acceptable method for contraception for the duration of the study.
• •≥ 18 years of age at the time of registration.
• •Patients must have adequate renal function as demonstrated by a serum creatinine \< 1.5 mg/dl unless felt to be secondary to lymphoma.
• •Must have an alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3.5 the upper limit of normal and a total bilirubin ≤ 2.0 mg/dL unless secondary to lymphoma.
• •Must have a cardiac left ventricular ejection fraction ≥ 50%.
• •At least 1 measurable tumor mass (greater than 1.5 cm in the longest dimension and greater than 1.0 cm in the short axis).
• •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.