Know Cancer

or
forgot password

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


Phase 2
60 Years
N/A
Open (Enrolling)
Both
Follicular Lymphoma

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate according to Cheson criteria 1999 after a short induction treatment by rituximab and bendamustine

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Pierre FEUGIER, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU Brabois, 54511 Vandoeuvre les Nancy

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

BRIEF

NCT ID:

NCT01313611

Start Date:

February 2011

Completion Date:

August 2015

Related Keywords:

  • Follicular Lymphoma
  • Lymphoma
  • Lymphoma, Follicular

Name

Location