None listed
Conditions
Brief summary
The purpose of this study is to determine the clinical utility of therapy based on the result of a PET-scan for patients with follicular lymphoma. Who is it for? You may be eligible for this study if you are aged over 18 and have a documented diagnosis of follicular lymphoma What it involves Participants in this study will be divided into groups (PET-ve and PET +ve) based on their PET-scan. PET +ve patients will be randomised (by chance) into two groups. One group (called Arm A) will have the drug Rituximab through a needle in the arm every 8 weeks for up to 22 months. The other PET +ve group (called Arm B) will also have Rituximab, but will also receive a drug called Lenalidomide by orally every month for up to 24 months. PET –ve patients will also be randomised (by chance) into two groups. One group (called Arm A) will have the drug Rituximab through a needle in the arm every 8 weeks for up to 22 months. The other PET –ve group (called Arm B) will receive no treatment. All participants in all groups and arms will be monitored for disease progression by physical examination and PET scans throughout their time in the study. It is hoped this study will demonstrate effectiveness of Lenalidomide in converting PET positive patients to PET negative patients. It is also hoped this research will show no treatment to be as effective as the current maintenance treatment (Rituximab) in PET negative patients.
Interventions
Randomised Phase III PET -response adapted maintenance therapy
Based on PET response (negative or positive) patients are randomised in the following manner -
Group 1: PET +ve (Deauville 4-5)
Arm A: Rituximab maintenance
Rituximab: 375 mg/m2 intravenous (or 1400 mg subcutaneously) on day 1 of each cycle, repeated every 8 weeks for up to 12 cycles
Arm B: Rituximab + lenalidomide (R2)
Rituximab 375 mg/m2 intravenously (or 1400 mg subcutaneously) on day 1 of each cycle of, repeated every 8 weeks
Randomised Phase III PET -response adapted maintenance therapy Based on PET response (negative or positive) patients are randomised in the following manner - Group 1: PET +ve (Deauville 4-5) Arm A: Rituximab maintenance Rituximab: 375 mg/m2 intravenous (or 1400 mg subcutaneously) on day 1 of each cycle, repeated every 8 weeks for up to 12 cycles Arm B: Rituximab + lenalidomide (R2) Rituximab 375 mg/m2 intravenously (or 1400 mg subcutaneously) on day 1 of each cycle of, repeated every 8 weeks for up to 12 cycles, a cycle lasts 28 days Lenalidomide oral tablet once daily on days 1 to 21 of every 28-day cycle (dose tailored to renal function and tolerance) for up to 24 cycles Group 2: PET –ve (Deauville 1-3) Arm A: Rituximab maintenance Rituximab: 375 mg/m2 intravenously (or 1400 mg subcutaneously) on day 1 of each cycle, repeated every 8 weeks for up to 12 cycles, a cycle last 28 days Arm B: No further treatment
Sponsors
University of Liverpool
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must be greater than or equal to 18 years of age at the time of signing the informed consent form. 2. Must be able to adhere to the study visit schedule and other protocol requirements. 3. Must have a documented diagnosis of follicular lymphoma (grade 1, 2 or 3a). 4. Must be at non-contiguous stage II, stage III or stage IV. 5. Must fulfil at least one of the Groupe d'Etude des Lymphomas Folliculaires (GELF) GELF criteria for high tumour burden: a. Systemic symptoms (> 10% weight loss, temperature greater than or equal to 38°C for more than 5 days, abundant night sweats) b. Performance status (PS) greater than 1 according to the Eastern Cooperative Oncology Group (ECOG) scale c. Elevated lactate dehydrogenase (LDH) level d. ß2-microglobulin level greater than 25.5 nM/L (3 µg/mL) e. A single lymph node larger than 7 cm f. Involvement of at least 3 nodal sites, each with diameter greater than 3 cm g. Marked splenomegaly h. Organ failure i. Pleural effusion or ascites j. Orbital or epidural involvement k. Blood infiltration l. Cytopenia 6. Must not have received prior systemic therapy (local radiotherapy is permitted). 7. Must have a WHO performance status score of less than or equal to 2. 8. Must agree to adhere to the Celgene guidance on pregnancy prevention.
Exclusion criteria
1. Any serious medical condition that would prevent the subject from participating in the study. 2. Known active infection with HIV, HBV or HCV. 3. Pregnant or lactating females. 4. Central nervous system involvement as documented by spinal fluid cytology or imaging. 5. History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, prostate cancer (TNM stage of T1a or T1b) 6. Any of the following laboratory abnormalities: a. Absolute neutrophil count (ANC) <1,000/µL (1.0 X 10^9/L) b. Platelet count <50,000/µL (50 X 10^9/L) c. Serum alanine transaminase (ALT) > 3.0 x upper limit of normal (ULN) d. Serum total bilirubin >1.5 x ULN unless due to Gilbert's Syndrome or biliary obstruction by lymphoma
Outcome results
None listed