None listed
Conditions
Brief summary
The prognosis for patients with FL has significantly improved during the last decade with the incorporation of Rituximab into therapy. Rituximab maintenance has become a standard of care after initial rituximab-chemotherapy for remission induction. Lenalidomide is an immune system modulating drug that has anti-lymphoma properties demonstrated in smaller studies of patients with relapsed/refractory Diffuse large B-cell lymphoma. Lenalidomide consolidation added to Rituximab maintenance therapy may convert PET+ patients to PET-, without causing unmanageable side effects. Positron emission tomography (PET) is a medical imaging tool that can detect cancer in its early stages, help to monitor cancer treatment and check if the cancer is coming back. Lay Summary: Follicular lymphoma is the most common type of slow growing non Hodgkin lymphoma. Treatments and outcomes have improved considerably in the last 10 years with the introduction of the drug, rituximab to standard chemotherapy treatments. However, the disease returns repeatedly in many patients. PET scanning is a type of test used by doctors to outline where the lymphoma is in the body. PET scans will ‘light up’ the areas of active follicular lymphoma. Such positive PET scans after the end of treatment indicate that it is likely the lymphoma will return soon. This study is for patients with returned disease who have already received treatment again and so are at even higher risk of disease returning yet again. Patients will receive rituximab and up to 24 months of another drug, lenalidomide, which is designed to help the body’s own immune system to keep the lymphoma away. The study will decide if the extra treatment with lenalidomide can change the scan result to negative and improve patient outcomes.
Interventions
Patients will undergo a Positron Emission Tomography (PET) scan and then be assigned to the PET+ or PET- arm of the study.
PET scan preparation and procedure will take approximately 2 hours. Patients will also be required to fast for four hours prior to the scan. Diabetic patients should discuss fasting requirements with their doctor. Plain, unflavoured water may be consumed while fasting.
Postinducton PET- patients:
Rituximab 375mg/m2 by i.v or 1400mg s.c every 3 months for 2 years.
Posti
Patients will undergo a Positron Emission Tomography (PET) scan and then be assigned to the PET+ or PET- arm of the study. PET scan preparation and procedure will take approximately 2 hours. Patients will also be required to fast for four hours prior to the scan. Diabetic patients should discuss fasting requirements with their doctor. Plain, unflavoured water may be consumed while fasting. Postinducton PET- patients: Rituximab 375mg/m2 by i.v or 1400mg s.c every 3 months for 2 years. Postinducton PET+ patients: Rituximab 375mg/m2 by i.v or 1400mg s.c every 3 months for 2 years, plus Lenalidomide consolidation therapy. Lenalidomide capsules will be administered at a starting dose of 10mg orally per day for 21 days of a 28 day cycle, for 6 months. After this patients will be reassessed via PET scan and treatment will be adapted based on these results: Patients remaining PET+ will continue Lenalidomide at a dose of 15mg/day for a maximum total of 2 years Lenalidomide therapy. Patients becoming PET- will continue Lenalidomide at a dose of 10mg/day for a maximum total of 2 years Lenalidomide therapy. If there is PET determined progression patients will discontinue Lenalidomide but continue to be followed.
Sponsors
Australasian Leukaemia and Lymphoma Group
Study design
Allocation
Non-randomised 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
Relapsed follicular lymphoma having obtained conventional Stable disease (SD), Partial Response (PR), Complete remission unconfirmed (CRu) or Complete Remission (CR) after most recent reinduction therapy. Response assessment within 4-6 weeks of day 1 of last chemotherapy cycle. Relapsed disease must be either Stage III or IV, or Stage II bulky disease defined as a tumor diameter of greater than or equal to 7 cm. Symptomatic disease in need of systemic immunochemotherapy treatment as defined by the investigator. Patient has provided written informed consent Life expectancy at least 6 months An Eastern Co-operative Oncology Group (ECOG) performance status score of less than or equal to 2 at Screening
Exclusion criteria
Patients with demonstrated histological transformation Patients who have: >6 prior cycles of Fludarabine Allogeneic transplant Prior exposure to Lenalidomide Patients who have had a negative PET scan during re-induction therapy Patients with poor haemopoeitic recovery 4-8 weeks post chemotherapy Patients with inadequate liver function Patients with severe renal impairment Medial contraindication to rituximab CNS involvement with lymphoma Any uncontrolled inter-current illness HIV, Hepatitis B or Hepatitis C infection Pregnant or breastfeeding women Prior malignancy, other than FL, unless free from disease / treatment for greater than or equal to 5 years. Exceptions include localised non-melanoma skin cancer and carcinoma in situ., and prostate cancer TNM Stage T1a or T1b Patients at high risk of venous thromboembolism who are not willing to take prophylaxis Patients with any psychiatric , social or geographic circumstance that would preclude protocol compliance
Outcome results
None listed