Phase
Condition
Lymphoma
Lymphoproliferative Disorders
Mantle Cell Lymphoma
Treatment
RB/RBAC alternating
RB
Clinical Study ID
Ages > 60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
newly diagnosed, previously untreated, histologically confirmed CD20+ mantle celllymphoma, confirmed by WHO classification criteria
age ≥70 years or 60-69 years if the patients are ineligible for high-dose therapywith autologous stem cell transplantation.
ECOG performance status 2 or less
Adequate organ functions
adequate heart function: LVEF ≥50% by echocardiography or MUGA
adequate renal function: serum creatinine ≤ 2.0mg/dL or CrCl ≥40 mL/min basedon the Cockcroft-Gault method
adequate hepatic function: ≤2.5 times the upper limit of ALT (≤5 times theupper limit of ALT if the elevation is attributed by underlying lymphoma) and ≤2 times the upper limit of ALT (≤3 times the upper limit of total bilirubin ifthe elevation is attributed by underlying lymphoma)
adequate hematologic function: absolute neutrophil counts (ANC) ≥ 1,500/mL,platelet counts ≥ 100,000/mL (any ANC and platelet counts are allowed, if theywere related to bone marrow involvement)
- Written informed consent
Exclusion
Exclusion Criteria:
In-situ mantle cell lymphoma
Ann Arbor stage 1 disease
Prior treatment for Hodgkin lymphoma or non-Hodgkin lymphoma within the last 5years.
Active malignancy within the past 3 years except for localized non-melanoma skincancer, papillary thyroid cancer, cervical carcinoma in situ, breast cancer in situ,or localized prostate cancer that has been definitely treated,
Central nervous system involvement
HBsAg (+) or anti-HBc Ab (+) (patients will be eligible if they receive appropriateprophylactic antiviral therapy using entecavir, tenofovir, and so on)
History of prior hepatitis C infection (patients positive for HCV IgG will beeligible if they are negative for HCV-RNA)
Known history of human immunodeficiency virus (HIV) infection
any serious illness or medical conditions that are unstable or could jeopardize thesafety of the patient and his/her compliance in the study
Congestive heart failure ≥ NYHA class 3
Acute coronary syndrome within 6 months (unstable angina or new-onset angina,myocardial infarct, or ventricular arrhythmia)
History of significant neurological or psychological disorder includingdementia and seizure disorder
Severe chronic obstructive pulmonary disease with hypoxemia
Cerebrovascular disease including transient ischemic attack within the past 6months
Non-healing wound, ulcer, or bone fracture
Active uncontrolled bacterial, viral, or fungal infection requiring systemictherapy
concomitant administration of any other experimental drugs under investigation
Known hypersensitivity to bendamustine, rituximab, cytarabine, or mannitol
major surgical procedure or significant trauma within 28 days before start of studytreatment, open biopsy within 7 days before start of study treatment
If the patient's partner is a woman who could possibly get pregnant, men who didn'thave a vasectomy must agree to use medically recommended methods for adequatecontraception (tubal ligation, intrauterine devices, or barriers [diaphragm,cervical cap] in the patient's partner and the use of condoms in men) when sexuallyactive.
Study Design
Study Description
Connect with a study center
Samsung Medical Center
Seoul, Gangnam-Gu 06351
Korea, Republic ofActive - Recruiting
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