Comparison of rituximab with lenalidomide or rituximab alone for patients with follicular lymphoma.

Phase 1

• Conditions: Patients having follicular lymphoma in need of therapy; MedDRA version: 14.1Level: LLTClassification code 10059432Term: Follicular mixed small and large cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-021253-39-IT
• Lead Sponsor: SAKK - GRUPPO SVIZZERO DI RICERCA CLINICA SUL CANCRO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-12
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

-Histologically confirmed FL CD20+; grade 1, 2, 3a; stage III+IV; stage II not suitable for radiotherapy -Patients in need of systemic therapy: (at least one of these indications must be fulfilled) •symptomatic enlarged lymph nodes, spleen or other lymphoma manifestations •bulky disease = 6 cm in long diameter •clinically significant progression over at least 6 months of any tumor lesion •anemia (Hb < 100 g/L) or thrombocytopenia (Platelets < 100 x 109/L) due to lymphoma •clinically significant progressive decrease in Hb or platelet count due to lymphoma •B-symptoms ,weight loss > 10 % in 6 months, drenching night sweats or fever > 38°C not due to infection -Patients must have at least one two-dimensionally measurable lesion with longest transverse diameter > 10 mm -Paraffin embedded tumor tissue is available for sending for pathology review -Age > 18 years -WHO performance status 0-2 -For patients with history of cardiac disease or older than 70 years: adequate cardiac function must be confirmed by EF = 50% -Adequate hematological values unless due to marrow infiltration by FL: (Neutrophils = 1.5 x 109/l, Platelets = 100 x 109/l) -Adequate hepatic function: Bilirubin = 1.5 x ULN (unless due to Gilbert’s syndrome), ALT/AP = 2.5 x ULN -Adequate renal function (calculated creatinine clearance = 30 ml/min, according to the formula of Cockroft- Gault) -Patient must give written informed consent before randomization -Patient compliance and geographic proximity allow proper staging and follow-up -Women with Childbearing potential •are not pregnant and agree not to become pregnant during participation in the trial and during the 12 months thereafter •are using effective contraception since 30 days at least •have a negative pregnancy test within 4 days before randomization -Men agree not to father a child, not to donate semen and to use condoms during trial treatment and 12 months thereafter -Patients (male and female) agree to follow the special pregnancy prevention requirements for Revlimid (lenalidomide)
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 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

-Previous systemic therapy for follicular lymphoma -Radiotherapy within the last 3 months -Known CNS involvement -Any serious underlying medical condition (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes) -Previous malignancy within 5 years with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer -Psychiatric disorder precluding understanding information of trial related topics, giving informed consent, or interfering with compliance for oral drug intake -Known hypersensitivity to trial drug(s) or hypersensitivity to any other component of the trial drugs -Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information -Concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to trial entry -Known HIV+ infection or HCV infection -Patients with any serological evidence of current or past hepatitis B, unless the serological findings are clearly due to vaccination -Patients regularly taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to Prednisone = 15 mg/day for indications other than lymphoma or lymphoma-related symptoms -Pregnant or lactating females -Patients in need of urgent chemotherapy, e.g. because of existing or imminent compression

Study & Design

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