Phase
Condition
Lymphoma
Follicular Lymphoma
Treatment
Vincristine
Lenalidomide
Cyclophosphamide
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Biopsy proven relapsed or refractory CD20 positive, grade 1-3a follicular lymphoma (biopsy within 3 months of trial entry)
- Aged 18 years or over
- Advanced disease that in the opinion of the treating physician requires treatment
- Patient suitable for standard available therapy at the Investigator's discretion
- Prior therapy with at least one line of immunochemotherapy. Previous radiotherapy atany time is permitted and will not count as a line of therapy. Previous rituximabmonotherapy is also permitted as long as patients have at any time also received atleast one line of immunochemotherapy
- Assessable disease by PET-CT (at least one involved node with long diameter >1.5cm, orextranodal lesion >1cm )
- ECOG performance status of 0, 1 or 2 at trial entry
- Adequate organ function defined as; i. ANC ≥ 1.0 x 109/L (growth factor use ispermitted) ii. Platelet count ≥ 75 x 109/L, or ≥ 50 x 109/L if bone marrowinfiltration or splenomegaly iii. ALT and AST level ≤3 x ULN iv. Direct bilirubinlevel ≤ 2 x ULN, unless due to Gilbert's syndrome v. CrCl ≥ 50mL/min (byCockcroft-Gault formula) vi. PT, INR and aPTT ≤ 1.5 x ULN, unless receivinganticoagulation vii. LVEF within normal limits by MUGA or echocardiography
- Able to provide written informed consent
- Women of childbearing potential (or their partners) must use an effective form ofcontraception
Exclusion
Exclusion Criteria:
- Current (or within 1 year) transformation to high grade lymphoma, including grade 3bfollicular lymphoma (patients with historical high-grade transformation over 1 yearago are eligible)
- Non-Fluorodeoxyglucose (FDG) avid disease
- Prior allogenic stem cell transplantation (SCT) or solid organ transplant
- Prior treatment with lenalidomide
- Treatment with CAR-T therapy within 100 days of starting trial treatment
- SCT or maintenance therapy planned within 24 weeks of starting treatment (patientsplanning SCT/maintenance after at least 24 weeks of treatment are eligible)
- Immunochemotherapy with a platinum-containing regimen planned
- Known serological positivity for HIV or uncontrolled HCV
- Hepatitis B surface antigen (HBsAg) positive and/or detectable viral DNA. Patientspositive for Hepatitis B core antibody (anti-HBc) but viral DNA negative are eligible
- Other malignancy within 2 years of enrolment, excepting cervical carcinoma stage 1B orless, non-invasive basal cell or squamous cell skin carcinoma, non-invasive,superficial bladder cancer, prostate cancer with a current PSA level <0.1ng/mL, anycurable cancer with a CR of > 2 years duration
- Active systemic infection requiring treatment
- Current or prior CNS involvement with lymphoma
- History of allergy or anaphylaxis to anti-CD20 monoclonal antibody therapy
- Known hypersensitivity to any of the experimental arm IMPs. Patients with a knownhypersensitivity to a control arm regimen may still be eligible if they have nohypersensitivity to other potential control arm IMPs.
- Serious medical or psychiatric illness likely to interfere with participation in thisclinical study
- Recent cancer treatment (chemotherapy, immunotherapy, biological therapy) within 4weeks of starting trial treatment; systemic steroid treatment (prednisolone > 10mgdaily (or equivalent)) within 7 days of cycle 1 day 1 dosing
- Unwilling to use appropriate contraception methods whilst on study treatment and for 12 months following end of treatment (or 18 months for female patients whose ICTregimen contains obinutuzumab)
- Women who are pregnant or breastfeeding
- Prior treatment with the experimental therapy under investigation
- Major surgery within 30 days of starting treatment
- Severe arrhythmias, heart failure, previous myocardial infarction, acute inflammatoryheart disease for ICT regimen containing doxorubicin, or severe heart failure (NewYork Heart Association Class IV) or severe, uncontrolled cardiac disease for ICTregimen containing rituximab
Study Design
Study Description
Connect with a study center
NHS Grampian
Aberdeen,
United KingdomSite Not Available
Belfast Health & Social Care Trust
Belfast,
United KingdomSite Not Available
University Hospitals Birmingham NHS Foundation Trust
Birmingham,
United KingdomSite Not Available
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool,
United KingdomSite Not Available
Cambridge University Hospitals NHS Foundation Trust
Cambridge,
United KingdomSite Not Available
Cardiff and vale University LHB
Cardiff,
United KingdomSite Not Available
University Hospitals Coventry and Warwickshire NHS Trust
Coventry,
United KingdomSite Not Available
Croydon Health Services NHS Trust
Croydon,
United KingdomSite Not Available
NHS Greater Glasgow and Clyde
Glasgow,
United KingdomSite Not Available
The Leeds Teaching Hospitals NHS Trust
Leeds,
United KingdomSite Not Available
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool,
United KingdomSite Not Available
Guy's and St Thomas' NHS Foundation Trust
London,
United KingdomSite Not Available
King's College Hospital NHS Foundation Trust
London,
United KingdomSite Not Available
The Royal Marsden NHS Foundation Trust
London,
United KingdomSite Not Available
University College London Hospital NHS Foundation Trust
London,
United KingdomSite Not Available
The Christie NHS Foundation Trust
Manchester,
United KingdomActive - Recruiting
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle,
United KingdomSite Not Available
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich,
United KingdomSite Not Available
Nottingham University Hospitals NHS Trust
Nottingham,
United KingdomActive - Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford,
United KingdomSite Not Available
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield,
United KingdomSite Not Available
University Hospital Southampton NHS Foundation Trust
Southampton,
United KingdomSite Not Available
University Hospital of North Midlands NHS Trust
Stoke-on-Trent,
United KingdomSite Not Available
Swansea Bay University Local Health Board
Swansea,
United KingdomSite Not Available
Torbay and South Devon NHS Foundation Trust
Torquay,
United KingdomSite Not Available
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