Bendamustine and rituximab in elderly untreated follicular lymphoma

• Register: EUCTR
• Last refreshed on: 23 July 2018
• Main ID: EUCTR2010-020757-14-BE
• Date of registration: 11/02/2011
• Prospective Registration: Yes
• Primary sponsor: LYSARC
• Public title: Bendamustine and rituximab in elderly untreated follicular lymphoma
• Scientific title: 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 - BRIEF
• Date of first enrolment: 27/07/2011
• Target sample size: 62
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020757-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: no; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Belgium

Contacts

• Name: Chairman of the study
• Affiliation: Professor Pierre Feugier

• Name: Chairman of the study
• Affiliation: Professor Pierre Feugier

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 et CD5
• Age must be = 60 years.
• Patients not previously treated.
• Patients with an intermediate or high risk FLIPI score requiring with one or more of the following adverse prognostic factors:
1. Ann Arbor Stage (I-II vs. III-IV)
2. Hemoglobin level ( < 12g/dL vs. = 12 g/dL)
3. Number of nodal areas (< 5 vs. = 5)
• 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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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
• 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
• Known HIV infection or active HBV or HCV infection
• 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:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

Initial diagnosis of histologically confirmed follicular lymphoma
MedDRA version: 14.1 Level: HLT Classification code 10016903 Term: Follicle centre lymphomas, follicular grade I, II, III System Organ Class: 100000004851

Intervention(s)

Trade Name: LEVACT
Product Name: bendamustine
Pharmaceutical Form: Powder for solution for infusion

Trade Name: MABTHERA
Product Name: rituximab
Pharmaceutical Form: Powder for solution for infusion

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: After the completion of the induction phase for all the 62 included patients

Secondary Objective: - Complete response rate at the end of induction according to Cheson 2007
- Overall response rates at the end of induction phase
- Overall response rate at the end of induction phase according to Cheson 2007
- Response rates at the end of maintenance phase according to Cheson 1999
- Response rates at the end of maintenance phase according toCheson 2007
- Duration of response
- Progression free survival
- Overall survival
- Time to next anti lymphoma treatment
- Immediate toxicity (grades 3 and 4, during the twelve first weeks)
- Long-term toxicity
- QoL evaluation

Main Objective: To evaluate the complete response rate according to Cheson criteria 1999 after a short induction treatment by Rituximab and Bendamustine in 1st line follicular lymphoma patients, = 60 years old, with an intermediate or high FLIPI score, and without high tumor burden (according to GELF criteria)

Primary end point(s): To evaluate the response rate after a short treatment by rituximab and bendamustine instead of a watch-and-wait approach.

Secondary Outcome(s)

Secondary end point(s): - Complete response rate at the end of induction according to Cheson 2007
- Overall response rates at the end of induction phase according to Cheson 1999
- Overall response rate at the end of induction phase according to Cheson 2007
- Response rates at the end of maintenance phase according to Cheson 1999
- Response rates at the end of maintenance phase according toCheson 2007
- Duration of response
- Progression free survival
- Overall survival
- Time to next anti lymphoma treatment
- Immediate toxicity (grades 3 and 4, during the twelve first weeks)
- Long-term toxicity
- QoL evaluation

Timepoint(s) of evaluation of this end point: - After the completion of the induction phase for all the 62 included patients
- After the completion of the maintenance phase for all the 62 included patients

Secondary ID(s)

BRIEF

NCT01313611

Source(s) of Monetary Support

Mundipharma

Roche