Immunochemotherapy With Rituximab-Bendamustine-Cytarabine for Patients With Mantle Cell Lymphoma Not Eligible for Intensive Regimens or Autologous Transplantation.
- Previously untreated patients with MCL aged 65 years or more, or <65 years if not
eligible for intensive treatments including/not including autologous transplantation.
- MCL patients of any age who relapse/progress or are resistant after one line of
- CD20+ .
- Karnofsky score of at least 70%
- Adequate renal function (Creatinine clearance >40 mL/min), with preserved diuresis.
- Adequate liver function: alanine aminotransferase (ALT)/aspartate aminotransferase
(AST) <2.5 x upper limit of normal (ULN) value, total bilirubin <2 mg/dL, unless
directly attributable to the patient's tumor.
- Negative serum pregnancy test 1 week prior to treatment both for pre-menopausal women
and for women who are <2 years after onset of menopause.
- Hepatitis B core antibody (HBcAb) positive patients may be enrolled if correct
antiviral prophylaxis is administered at least 2 weeks before initiating protocol
- Written informed consent.
- Prior treatment with Bendamustine.
- Refractoriness to Rituximab, defined as progressive disease during a previous cycle
including this drug, or relapse within 6 months to any previous cycle including
- Previous Rituximab infusion-related severe reactions.
- Human immunodeficiency virus (HIV) positive.
- Medical conditions or organ injuries that could interfere with administration of
- Active bacterial, viral, or fungal infection requiring systemic therapy.
- Seizure disorders requiring anticonvulsant therapy.
- Severe chronic obstructive pulmonary disease with hypoxaemia.
- History of severe cardiac disease: New York Heart Association (NYHA) functional class
III-IV, myocardial infarction within 6 months, ventricular tachyarrhythmias,
dilatative cardiomyopathy, or unstable angina.
- Uncontrolled diabetes mellitus.
- Active secondary malignancy.
- Known hypersensitivity or anaphylactic reactions to murine antibodies and proteins
(for patients treated with Rituximab), to Bendamustine or mannitol.
- Fertile men and women of childbearing potential unless surgically sterile or using
adequate measures of contraception.
- Major surgery within 4 weeks of study Day 1.
- HBsAg+ and HCV+ patients
- Any co-existing medical or psychological condition that would preclude participation
in the study or compromise the patient's ability to give informed consent, or that
may affect the interpretation of the results, or render the patient at high risk from