Rituximab plus lenalidomide or rituximab monotherapy for untreated patients with follicular lymphoma in need of therapy.
- Conditions
- ntreated patients with follicular lymphoma in need of therapy.MedDRA version: 14.0Level: PTClassification code 10025310Term: LymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-021253-39-DK
- Lead Sponsor
- Swiss Group for Clinical Cancer Research SAKK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 152
-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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
-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 3 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the activity of the combination of rituximab and lenalidomide given to untreated follicular lymphoma patients versus rituximab treatment.;Secondary Objective: Safety of the two therapy arms.;Primary end point(s): Complete response assessed at week 23 (+/- 1 week);Timepoint(s) of evaluation of this end point: week 23 (1/- 1 week) after treatment start
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Best Overall Response (OR) within 24 weeks<br>Best OR within 12 weeks<br>Best OR<br>Progression-free Survival<br>Duration of Complete Response<br>Time to first off-trial anti-lymphoma therapy<br>Overall Survival<br>AEs including lab abnormality assessments and vital signs;Timepoint(s) of evaluation of this end point: During follow-up phase of 10 years