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Efficacy and Safety of Bendamustine Plus Rituximab in Chronic Lympocytic Leukemia (LLC1315)

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.
 
ClinicalTrials.gov Identifier: NCT02491398
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary:
This study is intended for Chronic Lymphocytic Leukemia patients who have already undergone a first or second treatment with drugs named bendamustine and rituximab. It will observe the results of this treatment and evaluate its efficacy and side effects.

Condition or disease Intervention/treatment
Chronic Lymphocytic Leukemia Drug: Bendamustine + Rituximab

Detailed Description:
This cohort study will recruit chronic lymphocytic leukemia (CLL) patients who were treated with first and second-line Bendamustine plus Rituximab (BR) from January 2008 to December 2014 from European centres adhering to the GIMEMA group and the ERIC group, and aims at observing the progression-free survival in CLL patients.

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Study Type : Observational
Actual Enrollment : 494 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Observational Study to Assess the Efficacy and Safety of Bendamustine Plus Rituximab in Patients Affected by Chronic Lymphocytic Leukemia
Study Start Date : February 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017


Group/Cohort Intervention/treatment
First-line
Previously untreated CLL requiring therapy according to the NCI criteria and treated with at least one cycle of BR as first-line treatment.
Drug: Bendamustine + Rituximab
Second-line
CLL that received one previous line of treatment using alkylating agents and/or purine analogues with or without monoclonal antibodies, requiring second-line therapy according to the NCI criteria and treated with at least one cycle of BR.
Drug: Bendamustine + Rituximab



Primary Outcome Measures :
  1. Number of patients alive without progression [ Time Frame: At 12 months from treatment start ]
    Progression-free survival


Secondary Outcome Measures :
  1. Number of patients untreated [ Time Frame: At 12 months from treatment start ]
    Time-to-next treatment

  2. Number of patients attaining Complete Response (CR) [ Time Frame: At six months, that is, at the end of the induction therapy. ]
  3. Number of patients attainint CR/partial response (PR) [ Time Frame: At six months, that is, at the end of the induction therapy. ]
  4. Number of patients alive [ Time Frame: At 12 months from treatment start ]
  5. Number of patients with grade 3-4 adverse events [ Time Frame: At 12 months from treatment start ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This cohort study will recruit chronic lymphocytic leukemia (CLL) patients who were treated with first and second-line Bendamustine plus Rituximab (BR) from January 2008 to December 2014 from European centres adhering to the GIMEMA group and the ERIC group.
Criteria

Inclusion Criteria:

  • Diagnosis of CLL / Small Lymphocytic Lymphoma (CLL/) according to the World Health Organisation (WHO) classification 2008.
  • Patients who were treated with first and second-line Bendamustine plus Rituximab (BR) from January 2008 to December 2014 from European centres adhering to the GIMEMA group and the ERIC group.
  • Previously untreated CLL patients requiring therapy according to the NCI criteria (Hallek M et al, Blood 2008 - Appendix G) and treated with at least one cycle of BR as first-line treatment.
  • CLL patients that received one previous line of treatment using alkylating agents and/or purine analogues with or without monoclonal antibodies, requiring second-line therapy according to the NCI criteria (Hallek M et al, Blood 2008 - Appendix G) and treated with at least one cycle of bendamustine and rituximab.
  • Age ≥ 18 years old.
  • Signed written informed consent according to ICH/EU/GCP and national local law.

Exclusion Criteria:

  • Patients who have received 2 or more lines of prior therapy.
  • Patients with:

Transformation of CLL into aggressive lymphomas (Richter's Syndrome). HIV infection. Active and uncontrolled HCV and/or HBV infections or liver cirrhosis.


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 ClinicalTrials.gov identifier (NCT number): NCT02491398


Locations
Show Show 41 study locations
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
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Study Chair: Antonio Cuneo Ematologia; Azienda Ospedaliera di Ferrara
Study Director: Gian Matteo Rigolin Ematologia; Azienda Ospedaliera di Ferrara
Additional Information:
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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT02491398    
Other Study ID Numbers: LLC1315
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Rituximab
Bendamustine Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action