Bendamustine and rituximab in elderly untreated follicular lymphoma

Phase 1

• Conditions: Initial diagnosis of histologically confirmed follicular lymphoma; MedDRA version: 14.1Level: HLTClassification code 10016903Term: Follicle centre lymphomas, follicular grade I, II, IIISystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-020757-14-BE
• Lead Sponsor: YSARC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-11
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified