BRIEF Bendamustine and Rituximab In Elderly Follicular

This study has been terminated.
(Treament with rituximab during maintenance phase was stoped, according to DSMC recommendations, since 3 cases of deaths occured.)
Sponsor:
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier:
NCT01313611
First received: February 21, 2011
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

The objective of this study is to evaluate the complete response rate after a short induction treatment with rituximab (375mg/m2)and bendamustine (90mg/m2)in In Elderly (≥ 60 years old) patients with untreated Follicular lymphoma, with an intermediate or high FLIPI score and without high tumor burden.

This short induction is followed by a rituximab (375mg/m2)maintenance/ Induction schedule:Rituximab+Bendamustine on Day 1, Bendamustine on Day 2, Rituximab on Day 8, Rituximab on Day 15, rituximab on day 22, Bendamustine on Day 29, Bendamustine on Day 30 Maintenance schedule: 12 infusions of rituximab, each 8 weeks


Condition Intervention Phase
Follicular Lymphoma
Drug: Rituximab + bendamustine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: BRIEF: Bendamustine and Rituximab In Elderly Follicular: A Multicentric Phase II Study Evaluating the Benefit of a Short Induction Treatment by Bendamustine and Rituximab Followed by Maintenance Therapy With Rituximab In Elderly (≥ 60 Years Old) Patients With Untreated Follicular Lymphoma Patients, With an Intermediate or High FLIPI Score

Resource links provided by NLM:


Further study details as provided by The Lymphoma Academic Research Organisation:

Primary Outcome Measures:
  • Complete response rate according to Cheson criteria 1999 after a short induction treatment by rituximab and bendamustine [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete response rate according to Cheson criteria 1999 after 24 months of maintenance therapy with Rituximab [ Time Frame: 26 months ] [ Designated as safety issue: No ]
  • Partial and objective response rates at the end of induction phase [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: From the time of attainment of CR or PR to the date of first documented disease progression, relapse or death from any cause ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: From the date of randomization to the date of first documented disease progression, relapse, initiation of new anti-lymphoma therapy or death from any cause. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: From the date of randomization to the date of death from any cause ] [ Designated as safety issue: No ]
  • Time before retreatment [ Time Frame: From the end of primary treatment until the institution of the next therapy ] [ Designated as safety issue: No ]
  • Immediate toxicity [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Long term toxicity [ Time Frame: Until death of the patients ] [ Designated as safety issue: Yes ]
  • Evaluation of QoL [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: February 2011
Estimated Study Completion Date: June 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab+bendamustine Drug: Rituximab + bendamustine
Induction phase: rituximab and bendamustine on Day 1, Bendamustine on Day 2, Rituximab on Day 8, Rituximab on Day 15, Rituximab on Day 22, bendamustine on Day 29, Bendamustine on Day 30

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed follicular lymphoma CD20+, all grades except the grade 3b with a lymph node biopsy performed within 6 months before study entry and with material available for central review
  • A minimal initial immunology is required, including : CD20, bcl-2, CD10 and CD5
  • Age must be ≥ 60 years
  • Patients not previously treated
  • Patients with an intermediate or high risk FLIPI score requiring 2 or more of the following adverse prognostic factors:

    1. Age >60 ans
    2. Ann Arbor Stage (III-IV vs. I-II)
    3. Hemoglobin level ( < 12g/dL vs. ≥ 12 g/dL)
    4. Number of nodal areas (< 5 vs. ≥ 5) (Note: LDH should not be considered as an adverse prognostic factor in this study since it is considered as high tumor burden in the GELF criteria)
  • Low burden disease at study entry according to the GELF criteria
  • Patients with at least one measurable site of disease: patients with only blood or marrow or splenic infiltration are excluded
  • Performance status ≤ 2 on the ECOG scale
  • Adequate hematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow) including:
  • Hemoglobin ≥ 8.0 g/dL (5.0 mmol/L)
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Platelet count ≥ 100 x 109/L
  • Adequate renal function: calculated creatinine clearance > 50 ml/min (according to MDRD method) unless these abnormalities are related to lymphoma
  • Adequate hepatic function: Total bilirubin < 2.0 mg/dl (34 µmol/L), AST (SGOT) and ALT (SGPT) ≤ 2.5 x the upper limit of normal unless these abnormalities are related to lymphoma
  • Adequate cardiac function: LEVF ≥ 50% calculated by echocardiography or scintigraphy
  • Having previously signed a written informed consent

Exclusion Criteria:

  • Other histological types of lymphoma than follicular lymphoma
  • Grade 3b follicular lymphoma
  • Patients previously on watch and wait since more than 6 months from diagnosis
  • Patients previously treated for lymphoma, except splenectomy
  • Patients with low FLIPI score (0 or 1 adverse prognostic factors not considering elevated LDH)
  • Bulky disease at study entry according to the GELF criteria
  • Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis)
  • Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer or previous cancer in CR without any treatment in the last 5 years
  • Positive HIV, HBV (anti-HBc positivity) and HCV serologies before inclusion
  • Poor Performance status > 2 on the ECOG scale
  • Known contra-indication to study product
  • Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease).
  • Any other co-existing medical or psychological condition that will preclude participation in the study or compromise ability to give informed consent.
  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: NCT01313611

  Show 117 Study Locations
Sponsors and Collaborators
The Lymphoma Academic Research Organisation
Investigators
Principal Investigator: Pierre FEUGIER, MD CHU Brabois, 54511 Vandoeuvre les Nancy
  More Information

No publications provided

Responsible Party: The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier: NCT01313611     History of Changes
Other Study ID Numbers: BRIEF
Study First Received: February 21, 2011
Last Updated: May 28, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 18, 2014