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Rituximab Plus Bendamustine as Front Line Treatment in Frail Elderly (>70 Years) Patients With DLBCL: a Phase II Multicenter Study of the FIL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01990144
Recruitment Status : Unknown
Verified November 2013 by Fondazione Italiana Linfomi ONLUS.
Recruitment status was:  Recruiting
First Posted : November 21, 2013
Last Update Posted : November 21, 2013
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS

Brief Summary:
The purpose of the study is to evaluate feasibility and efficacy of rituximab-bendamustine (R-B)combination in elderly patients affected by diffuse large B-cell lymphoma and defined as frail according to CGA.

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Drug: Bendamustine+Rituximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rituximab Plus Bendamustine as Front Line Treatment in Frail Elderly (>70 Years) Patients With Diffuse Large B-cell Non-Hodgkin's Lymphoma: a Phase II Multicenter Study of the Fondazione Italiana Linfomi (FIL)
Study Start Date : November 2011
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2016

Arm Intervention/treatment
Experimental: Bendamustine
Bendamustine is a novel chemotherapeutic agent, a hybrid of a purine analogue and an alkylator. It shows only partial in vitro cross-resistance with other alkylating agents and it is clinically well tolerated. In fact it has shown to be active in vitro against cell lines which are resistant to other alkylating agents. Preclinical data demonstrate that bendamustine acts in two distinct ways to kill cancer cells: it damages the DNA in cancer cells, which leads to cell death by a process known as apoptosis (programmed cell death) as well as by an alternate cell death pathway known as mitotic catastrophe (a disruption of normal cell division). This dual-effect may be attributable to its unique chemical structure.Bendamustine has demonstrated clinical activity in patients with chronic lymphocytic leukaemia, patients with relapsed indolent NHL, mantle cell lymphoma, multiple myeloma and several solid tumors.
Drug: Bendamustine+Rituximab

Patients will receive :

  • Rituximab 375 mg/m2 intravenously on day 1*
  • Bendamustine 90 mg/m2 intravenously on days 2 and 3** Treatment will be administered on a 28-day cycle basis.

    • Administration of rituximab during cycle 1 is postponed to day 8, thereafter on day 1.

      • After the first cycle, bendamustine can be administered on days 1-2 or days 2-3 according to Institutional/patient/physician choice.

Primary Outcome Measures :
  1. To evaluate the activity of R-B combination in terms of complete response rate (CRR). [ Time Frame: 4 years ]
  2. To evaluate the safety and tolerability of R-B combination in terms of rate of adverse events occurrence. [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. To evaluate progression free survival (PFS) [ Time Frame: 4 years ]
  2. To evaluate overall survival (OS) [ Time Frame: 4 years ]

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Histologically proven CD20 positive diffuse large B-cell non-Hodgkin's lymphoma
  • Age > 70 years
  • No previous treatment
  • FRAIL patients defined as follows (see Appendices B-E) Age > 80 years with UNFIT profile, i.e.

    • ADL > 5 residual functions
    • IADL > 6 residual functions
    • CIRS 5-8 co-morbidities of grade 2

or Age < 80 years with

  • ADL < 4 residual functions, or
  • IADL < 5 residual functions, or
  • CIRS : 1 co-morbidity of grade 3-4, or > 8 co-morbidities of grade 2

    • Life expectancy > 6 months
    • Written informed consent
    • Accessibility of patient for treatment and follow up

Exclusion Criteria:

  • History of other malignancies within 5 years prior to study entry except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
  • Previous exposure to cytotoxic agents
  • Suspect or clinical evidence of CNS involvement by lymphoma
  • HBsAg, HCV or HIV positivity; HBcAb positivity is accepted only with concomitant treatment with Lamivudine
  • AST /ALT > twice upper the normal range; bilirubin > twice upper the normal range; serum creatinine > 2.5 mg /dl
  • Evidence of any severe active acute or chronic infection
  • Concurrent co-morbid medical condition which might exclude administration of full dose chemotherapy
  • Senile dementia
  • Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01990144

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Contact: Marco Calabrese, Dr +39 0131 206129
Contact: Sonia Perticone, Dr +39 0131 206129

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Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
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Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Fondazione Italiana Linfomi ONLUS Identifier: NCT01990144     History of Changes
Other Study ID Numbers: FIL_R-BENDA FRAIL
First Posted: November 21, 2013    Key Record Dates
Last Update Posted: November 21, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Bendamustine Hydrochloride
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action