A PHASE III MULTICENTER, RANDOMIZED STUDY COMPARING CONSOLIDATION WITH (90)YTTRIUM-LABELED IBRITUMOMAB TIUXETAN (ZEVALIN®) RADIOIMMUNOTHERAPY VS AUTOLOGOUS STEM CELL TRANSPLANTATION (ASCT) IN PATIENTS WITH RELAPSED FOLLICULAR LYMPHOMA (FL) AGED 18-65 YEARS

• Conditions: Patients aged 18-65 years with follicular lymphoma in first or second relapse; MedDRA version: 14.1Level: PTClassification code 10016905Term: Follicle centre lymphoma, follicular grade I, II, III recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-000251-14-IT
• Lead Sponsor: FONDAZIONE ITALIANA LINFOMI ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-11
• Last Update Posted: 28 October 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Age 18-65; 2.Histologically documented diagnosis of grade I-IIIa FL defined according to WHO guidelines 2008 (Re-biopsy required); 3.Collection of BM and PB for MRD analysis; 4.Relapsed or refractory disease after = 2 chemotherapy lines at least one containing rituximab (rituximab maintenance is not considered a therapeutic line); 5.Clinical indication of systemic treatment i.e. Stage II-IV who require therapy according to SIE and GELF criteria; 6.ECOG performance status 0-2 (unless disease-related); 7.Availability of histological material for centralized revision; 8.Laboratory values: •ANC = 1500/mmc and/or platelets = 100000/mmc (unless due to marrow involvement by lymphoma) •Serum creatinine = 1.5 x ULN (unless disease-related) •bilirubin = 1.5 x ULN (or = 3.0 x ULN, if patient has Gilbert’s syndrome), AST/SGOT and/or ALT/SGPT = 2.5 x ULN if not disease related or = 5.0 x ULN in case of lymphoma liver involvement; 9.Adequate cardiac function: LVEF > 50% by echocardiography or MUGA scan; 10.Not pregnant or breast-feeding; 11.Willingness to use effective contraception during the study and 3 months after the end of treatment; 12.No other prior malignancies except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histological finding of prostate cancer (TNM stage of T1a or T1b) or other cancer from which the patient has been disease-free for > 5 years; 13.Signed informed written 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 245
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1.Grade IIIb FL, transformed FL or histologies different from FL; 2.Previous treatment with > 2 lines of chemotherapy ± rituximab (rituximab maintenance is not considered a treatment line); 3.Previous ASCT or RIT treatment; 4.CNS involvement by lymphoma; 5.HBV positivity (except of patients HbcAb positive and HbsAg negative, HBV-DNA negative, provided lamivudine prophylaxis is given); 6.HCV positivity with active virus replication (HCV-RNA copies in serum), active hepatitis or impaired liver function. 7.HIV positivity; 8.Any concurrent medical condition requiring long term use (greater than one month) of systemic corticosteroids; 9.Active bacterial, viral, or fungal infection requiring systemic therapy; 10.Any concurrent medical or psychiatric condition which might impair administration of therapy or preclude the ability to give informed consent; 11.Treatment within an experimental agent within 30 days prior to study entry; 12.Myelosuppressive chemotherapy or biological therapy within three weeks before study entry (use rituximab course delivered as maintenance is not an exclusion therapy); 13.Major surgery other than diagnosis within four weeks prior to study entry.14.Previous i.v. or i.m. treatments with murine or animal derived antibodies.

Study & Design

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