Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy (NCT05848765) | Clinical Trial Compass
RecruitingPhase 2
Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy
United Kingdom284 participantsStarted 2023-09-04
Plain-language summary
The aim of the REFRACT clinical trial is to find new therapies with improved outcomes compared to the current standard treatment available, in patients with relapsed or refractory follicular lymphoma. This will be done by comparing patients who have received a new treatment against patients who receive standard treatment based on their response to the treatment received.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 at any time is permitted and will not count as a line of therapy. Previous rituximab monotherapy is also permitted as long as patients have at any time also received at least one line of immunochemotherapy
✓. Assessable disease by PET-CT (at least one involved node with long diameter \>1.5cm, or extranodal 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 is permitted) ii. Platelet count ≥ 75 x 109/L, or ≥ 50 x 109/L if bone marrow infiltration or splenomegaly iii. ALT and AST level ≤3 x ULN iv. Direct bilirubin level ≤ 2 x ULN, unless due to Gilbert's syndrome v. CrCl ≥ 50mL/min (by Cockcroft-Gault formula) vi. PT, INR and aPTT ≤ 1.5 x ULN, unless receiving anticoagulation vii. LVEF within normal limits by MUGA or echocardiography
Exclusion criteria
✕. Current (or within 1 year) transformation to high grade lymphoma, including grade 3b follicular lymphoma (patients with historical high-grade transformation over 1 year ago are eligible)
✕. 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 (patients planning 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