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Phase II Study of Age‐Adjusted R‐BAC (Rituximab, Bendamustine, Cytarabine) as Induction Therapy in Older Patients With Mantle Cell Lymphoma (MCL)

Phase 2
65 Years
Open (Enrolling)
Mantle Cell Lymphoma

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Trial Information

Phase II Study of Age‐Adjusted R‐BAC (Rituximab, Bendamustine, Cytarabine) as Induction Therapy in Older Patients With Mantle Cell Lymphoma (MCL)

Study End points Primary efficacy end point of the study is the proportion of CR defined
according to Cheson criteria (2007) at the end of treatment (6 or 4 cycles). Primary safety
end point is the occurrence of any of the stop treatment criteria or of any episode of
relevant toxicity, as above defined.

Secondary end points are MRD defined response, OS, PFS and DOR (Cheson 2007). Molecular
response is the proportion of patients with molecular rearrangements at baseline that become
negative during treatment, measured by qualitative and quantitative PCR.

OS is measured from enrollment until death from any cause. PFS is measured from the time of
enrollment until disease progression, relapse or death from any cause. DOR is measured from
the first assessment that documents response (CR or PR) to the date of disease relapse or
progression. Minimum follow up required for all patients will be 24 months.

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

- 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)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

complete remission rate at the end of treatment

Outcome Description:

The primary objective is to determine the activity [complete remission rate (CR) according to Cheson 2007 criteria]

Outcome Time Frame:

6 months

Safety Issue:



Italy: Ministry of Health

Study ID:




Start Date:

February 2012

Completion Date:

January 2016

Related Keywords:

  • Mantle Cell Lymphoma
  • MCL
  • Mantle Cell Lymphoma
  • Older
  • Lymphoma
  • Lymphoma, Mantle-Cell