An Open-Label, Randomized, Parallel-Group Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in the First-Line Treatment of Patients With Advanced Indolent Non-Hodgkin´s Lymphoma (NHL) or Mantle Cell Lymphoma (MCL)
- Conditions
- -C83 Non-follicular lymphomaNon-follicular lymphomaC83
- Registration Number
- PER-151-09
- Lead Sponsor
- TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 11
• Histopathological confirmation of 1 of the following non-Hodgkin CD20 + B cell lymphomas (WHO / European American Revised Classification of Lymphoid Neoplasms [REAL] descriptions are described below). Tissue diagnostic procedures should be performed within 6 months of admission to the study and with biopsy material available for review: follicular lymphoma (grade 1 or 2), immunoplasmacytoma / immunocytoma (Waldenstrom macroglobulinemia), cell lymphoma Splenic B of the marginal zone, lymphoma of the extraganglionic marginal zone of the type of lymphoid tumor associated with mucosa (MALT), lymphoma of B cells of the marginal ganglionic zone, mantle cell lymphoma.
• The patient has CD20 positive B cells in the lymph node biopsy or other pathological sample of lymphoma.
• The patient did not receive prior treatment. Patients on observation and waiting can enter the study if a recent biopsy can be obtained (obtained within the last 6 months).
• The patient has adequate hematological function (unless the abnormalities are related to infiltration of lymphoma in the bone marrow or hypersplenism due to lymphoma) within 30 days prior to the start of the administration of the study medication as evidenced by the following points: hemoglobin of 10.0 g / dl or greater, absolute neutrophil count (ANC) of 1.5 x 10 ^ 9 / L or greater, platelet count of 100 x10 ^ 9 / L or greater
• The patient has a two-dimensional measurable disease with at least 1 lesion measuring 2.0 was or more in a single dimension, and the field was not previously irradiated.
• The patient can provide written informed consent.
• The patient is over 18 years of age at the time of giving informed consent.
• The patient has a functional ECOG status of 2 or less.
• The patient has an estimated life expectancy of at least 6 months.
• The patient has serum creatinine of 2.0 mg / dL or less, or CrCl of 50 mL / min or greater based on the Cockcroft-Gault method or urine collection for 24 hours.
• The patient has adequate liver function (<2.5 times the upper limit of normal for alanine aminotransferase [ALT] and asparate aminotransferase [AST], and alkaline phosphatase and total bilirubin are within normal limits).
• The patient has a left ventricular ejection fraction (LVEE) of 50% or greater according to MUGA or ECHO within 30 days prior to the start of treatment with the study medication for any patient who will be treated with R-CHOP.
• Men who are not surgically sterile or who are capable of having offspring must practice abstinence or use a barrier method of contraception and must agree to continue using this method for the duration of treatment and for 30 days after the end of treatment.
• The patient has chronic lymphocytic leukemia, small cell lymphocytic lymphoma or grade 3 follicular lymphoma.
• The patient has transformed disease. Specifically, blasts are allowed in the bone marrow; however, transformed disease that indicates leukemic involvement is not allowed.
• The patient has or has a history of central nervous system (CNS) involvement or leptomeningeal lymphoma.
• The patient performed a previous treatment for NHL, with the exception of a single batch of madly delimited radiotherapy (radiation field not exceeding 2 adjacent lymph node regions).
• The patient had an active neoplasm, other than NHL, within the last 3 years, except for localized prostate cancer treated with hormonal therapy, cervical carcinoma in situ, breast cancer in situ or non-melanoma skin cancer that was treated as definitive
• The patient has Class III or IV heart failure according to the New York Cardiology Association (NYHA), arrhythmias or unstable angina, electrocardiographic evidence of active ischemia or active abnormalities of the conduction system or myocardial infarction during the last 6 months. (Before entering the study, abnormalities in the ECO in the selection must be documented by the investigator as not medically relevant).
• The patient has a known human immunodeficiency virus (HIV) infection.
• The patient has an active hepatitis B or hepatitis C infection. Hepatitis B surface antigen should be tested; otherwise, the investigator must determine active hepatitis B or C.
• The patient is pregnant or breastfeeding. (Every woman who becomes pregnant during the study will be withdrawn from the study.)
• The patient received corticosteroids to treat lymphoma within 28 days of admission to the study. Low-dose corticosteroids administered chronically (e.g., prednisone <20 mg / day) are allowed for indications other than lymphoma or lymphoma-related complications.
• The patient has some serious uncontrolled medical or psychological disorder that would impair the patient´s ability to receive protocol therapy.
• The patient has a condition that puts the patient in front of an unacceptable risk or confuses the ability of researchers to interpret the study data,
• The patient received another investigating agent within 28 days of entering the study.
• The patient has known hypersensitivity to bendamustine, mannitol or other medications related to the study.
• The patient has stage I disease according to the Ann Arbor classification.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method