BRIEF Bendamustine and Rituximab In Elderly Follicular

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01313611
• Date of registration: 21/02/2011
• Prospective Registration: No
• Primary sponsor: The Lymphoma Academic Research Organisation
• Public title: BRIEF Bendamustine and Rituximab In Elderly Follicular BRIEF
• Scientific 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
• Date of first enrolment: February 2011
• Target sample size: 62
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01313611
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Belgium, France

Contacts

• Name: Pierre FEUGIER, MD
• Affiliation: CHU Brabois, 54511 Vandoeuvre les Nancy

Key inclusion & exclusion 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.



Age minimum: 60 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Follicular Lymphoma

Intervention(s)

Drug: Rituximab + bendamustine

Primary Outcome(s)

Complete response rate according to Cheson criteria 1999 after a short induction treatment by rituximab and bendamustine [Time Frame: 12 weeks]

Secondary Outcome(s)

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.]

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]

Time before retreatment [Time Frame: From the end of primary treatment until the institution of the next therapy]

Partial and objective response rates at the end of induction phase [Time Frame: 12 weeks]

Complete response rate according to Cheson criteria 1999 after 24 months of maintenance therapy with Rituximab [Time Frame: 26 months]

Immediate toxicity [Time Frame: 12 weeks]

Evaluation of QoL [Time Frame: 7 years]

Long term toxicity [Time Frame: Until death of the patients]

Overall survival [Time Frame: From the date of randomization to the date of death from any cause]

Secondary ID(s)

BRIEF

Source(s) of Monetary Support

Please refer to primary and secondary sponsors