Immunochemotherapy With Rituximab-Bendamustine-Cytarabine (R-BAC) for Patients With Mantle Cell Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carlo Visco, St. Bortolo Hospital
ClinicalTrials.gov Identifier:
NCT00992134
First received: October 7, 2009
Last updated: September 25, 2012
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Lymphoma, Mantle-Cell
Drug: Rituximab, Bendamustine, Cytarabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immunochemotherapy With Rituximab-Bendamustine-Cytarabine for Patients With Mantle Cell Lymphoma Not Eligible for Intensive Regimens or Autologous Transplantation.

Resource links provided by NLM:


Further study details as provided by St. Bortolo Hospital:

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 ]

Enrollment: 41
Study Start Date: June 2009
Study Completion Date: June 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

    Other Names:
    • Ribomustin
    • Mabthera
    • Ara-C
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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

Locations
Italy
Department of Hematology, Ospedale San Bortolo
Vicenza, VI, Italy, 36100
Sponsors and Collaborators
St. Bortolo Hospital
Investigators
Principal Investigator: Carlo Visco, MD Department of Hematology, San Bortolo Hospital, Vicenza
  More Information

No publications provided by St. Bortolo Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carlo Visco, MD, St. Bortolo Hospital
ClinicalTrials.gov Identifier: NCT00992134     History of Changes
Other Study ID Numbers: VI-1903, EudraCT 2009-009912-34
Study First Received: October 7, 2009
Last Updated: September 25, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by St. Bortolo Hospital:
Lymphoma, Mantle-Cell
Bendamustine
Cytarabine
Rituximab
Treatment
Combination chemotherapy

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Bendamustine
Cytarabine
Nitrogen Mustard Compounds
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on October 01, 2014