A Study Comparing Rituximab/Bendamustin(RB) Alternating With Rituximab/Bendamustin/Cytarabin(RBAC) With RB Therapy in Elderly Patients With Mentle Cell Lymphoma

Korábbi kezelés

• Prior treatment for Hodgkin lymphoma or non-Hodgkin lymphoma within the last 5 years.
• HBsAg (+) or anti-HBc Ab (+) (patients will be eligible if they receive appropriate prophylactic antiviral therapy using entecavir, tenofovir, and so on)
• History of prior hepatitis C infection (patients positive for HCV IgG will be eligible if they are negative for HCV-RNA)
• concomitant administration of any other experimental drugs under investigation
• major surgical procedure or significant trauma within 28 days before start of study treatment, open biopsy within 7 days before start of study treatment

Más betegség

• Ann Arbor stage 1 disease
• Active malignancy within the past 3 years except for localized non-melanoma skin cancer, papillary thyroid cancer, cervical carcinoma in situ, breast cancer in situ, or localized prostate cancer that has been definitely treated,
• Known history of human immunodeficiency virus (HIV) infection
• any serious illness or medical conditions that are unstable or could jeopardize the safety 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 including dementia and seizure disorder
  • Severe chronic obstructive pulmonary disease with hypoxemia
  • Cerebrovascular disease including transient ischemic attack within the past 6 months
  • Non-healing wound, ulcer, or bone fracture
  • Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
• Known hypersensitivity to bendamustine, rituximab, cytarabine, or mannitol

Egyéb

• In-situ mantle cell lymphoma
• Central nervous system involvement
• If the patient's partner is a woman who could possibly get pregnant, men who didn't have a vasectomy must agree to use medically recommended methods for adequate contraception (tubal ligation, intrauterine devices, or barriers \[diaphragm, cervical cap\] in the patient's partner and the use of condoms in men) when sexually active.

• newly diagnosed, previously untreated, histologically confirmed CD20+ mantle cell lymphoma, confirmed by WHO classification criteria
• age ≥70 years or 60-69 years if the patients are ineligible for high-dose therapy with 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 based on the Cockcroft-Gault method
  • adequate hepatic function: ≤2.5 times the upper limit of ALT (≤5 times the upper 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 if the 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 they were related to bone marrow involvement)
• Written informed consent