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

NCT00992134 | Completed Phase 2 DMC

• 2 other identifiers: VI-1903EudraCT 2009-009912-34
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoma, Mantle-Cell

Keywords

Lymphoma, Mantle-Cell; Bendamustine; Cytarabine; Rituximab; Treatment; Combination chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  June 2011

Secondary Outcomes (1)

• Overall response and freedom from progression after R-BAC treatment

  June 2011

Interventions

Rituximab, Bendamustine, Cytarabine DRUG

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.

Also known as: Ribomustin, Mabthera, Ara-C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Bortolo Hospital: lead

Study Sites (1)

Department of Hematology, Ospedale San Bortolo

Vicenza, VI, 36100, Italy

Location

Related Publications (1)

• 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. Epub 2013 Feb 11.

  PMID: 23401442 DERIVED

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

Rituximab; Bendamustine Hydrochloride; Cytarabine

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Carlo Visco, MD

  Department of Hematology, San Bortolo Hospital, Vicenza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 7, 2009
• First Posted: October 9, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2012
• Last Updated: September 26, 2012

Record last verified: 2010-09

Locations

IT (1)