Immunochemotherapy With Rituximab-Bendamustine-Cytarabine (R-BAC) for Patients With Mantle Cell Lymphoma
Information source: St. Bortolo Hospital
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma, Mantle-Cell
Intervention: Rituximab, Bendamustine, Cytarabine (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: St. Bortolo Hospital Official(s) and/or principal investigator(s):
Carlo Visco, MD, Principal Investigator, Affiliation: Department of Hematology, San Bortolo Hospital, Vicenza
Overall contact:
Carlo Visco, MD, Phone: +39 0444 753626, Email: carlovisco@hotmail.com
Summary
The objective of the study is to demonstrate the safety, tolerability, and activity of
Rituximab-Bendamustine-Cytarabine(R-BAC) regimen in patients with mantle cell lymphoma (MCL)
aged 65 years or more, as well as in younger patients who are not eligible for intensive
regimens including/not including autologous transplantation.
Clinical Details
Official title: Immunochemotherapy With Rituximab-Bendamustine-Cytarabine for Patients With Mantle Cell Lymphoma Not Eligible for Intensive Regimens or Autologous Transplantation.
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The safety and tolerability of R-BAC treatment will be tested to determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of Ara-C when combined with Bendamustine and Rituximab.
Secondary outcome: Overall response and freedom from progression after R-BAC treatment
Detailed description:
Since Bendamustine has recently shown promising safety and efficacy in combination with
monoclonal antibodies in the treatment of patients with MCL, the goal of this study is to
investigate the possible therapeutic benefit of combining Ara-C with Bendamustine and
Rituximab (R-BAC). All three agents exhibit individual and unique mechanisms of action in
MCL, and a synergistic or additive effect might be expected when these agents are used in
combination, as suggested by the pre-clinical studies.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
chemotherapy.
- 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
treatment.
- Written informed consent.
Exclusion Criteria:
- 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
Rituximab.
- Previous Rituximab infusion-related severe reactions.
- Human immunodeficiency virus (HIV) positive.
- 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 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
treatment complications.
Locations and Contacts
Carlo Visco, MD, Phone: +39 0444 753626, Email: carlovisco@hotmail.com
Department of Hematology, Ospedale San Bortolo, Vicenza, VI 36100, Italy; Recruiting
Carlo Visco, MD, Phone: +39 0444 753626, Email: carlovisco@hotmail.com
Francesco Rodeghiero, MD, Email: rodeghiero@hemato.ven.it
Additional Information
Starting date: June 2009
Last updated: July 21, 2010
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