Immunochemotherapy With Rituximab-Bendamustine-Cytarabine (R-BAC) for Patients With Mantle Cell Lymphoma
This study has been completed.
Information provided by (Responsible Party):
Carlo Visco, St. Bortolo Hospital
First received: October 7, 2009
Last updated: September 25, 2012
Last verified: September 2010
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.
Drug: Rituximab, Bendamustine, Cytarabine
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Immunochemotherapy With Rituximab-Bendamustine-Cytarabine for Patients With Mantle Cell Lymphoma Not Eligible for Intensive Regimens or Autologous Transplantation.
Primary Outcome Measures:
- 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. [ Time Frame: June 2011 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Overall response and freedom from progression after R-BAC treatment [ Time Frame: June 2011 ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2011 (Final data collection date for primary outcome measure)
Drug: Rituximab, Bendamustine, Cytarabine
Rituximab IV 375 mg/m2 on day 1. Bendamustine IV 70 mg/m2 over a 30-60 minute infusion on day 1 and 2. Cytarabine IV 800 mg/m2, over a 2-hour infusion, 2 hours after Bendamustine, on Day 1, 2, and 3.
Four to six cycles. Recycle every 28 days.
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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992134
|Department of Hematology, Ospedale San Bortolo
|Vicenza, VI, Italy, 36100 |
St. Bortolo Hospital
||Carlo Visco, MD
||Department of Hematology, San Bortolo Hospital, Vicenza
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Visco C, Finotto S, Zambello R, Paolini R, Menin A, Zanotti R, Zaja F, Semenzato G, Pizzolo G, D'Amore ES, Rodeghiero F. Combination of rituximab, bendamustine, and cytarabine for patients with mantle-cell non-Hodgkin lymphoma ineligible for intensive regimens or autologous transplantation. J Clin Oncol. 2013 Apr 10;31(11):1442-9. doi: 10.1200/JCO.2012.45.9842.
||Carlo Visco, MD, St. Bortolo Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 7, 2009
||September 25, 2012
||Italy: Ethics Committee
Keywords provided by St. Bortolo Hospital:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on January 14, 2017
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating