Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-24 @ 5:20 PM
NCT ID:
NCT01662050
Eligibility Criteria:
Inclusion Criteria:
* Previously untreated patients with MCL aged \> 65 years if they are FIT according to the geriatric CGA assessment.
* age 60-65 years not eligible to high-dose chemotherapy plus transplantation, FIT or UNFIT according to the geriatric CGA assessment.
* ECOG performance status ≤ 2.
* Positivity for cyclin D1 and SOX11 \[the latter being mandatory in cases lacking cyclin D1- or t(11;14)-negative\], CD20 and CD5.
* 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.
* Hepatitis B core antibody (HBcAb) positive/HBsAg negative/HBV-DNA negative patients may be enrolled if correct antiviral prophylaxis is administered at least 2 weeks before initiating protocol treatment.
* Written informed consent.
Exclusion Criteria:
* Human immunodeficiency virus (HIV) positive.
* Previous treatment for lymphoma
* Medical conditions or organ injuries that could interfere with administration of therapy.
* Active bacterial, viral, or fungal infection requiring systemic therapy.
* Seizure disorders requiring anticonvulsant therapy.
* Severe chronic obstructive pulmonary disease with hypoxemia.
* 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, to Bendamustine or mannitol.
* Major surgery within 4 weeks of study Day 1.
* HBsAg+
* HCVAb+ patients with active viral replication (HCV-RNA+ with AST \> 2 x normal limit)
* 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 treatment complications.
* CNS involvement (a diagnostic lumbar puncture will be performed in patients with the blastoid variant of MCL)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT01662050
Study Brief:
Protocol Section:
NCT01662050