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OncoMatch/Clinical Trials/NCT05848765

Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy

Is NCT05848765 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for relapsed follicular lymphoma.

Phase 2RecruitingUniversity of BirminghamNCT05848765Data as of May 2026

Treatment: Epcoritamab · Lenalidomide · Rituximab · Obinutuzumab · Bendamustine · Vincristine · Doxorubicin · Cyclophosphamide · Prednisone · Investigation agent 2 · Investigation agent 3The 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.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Biomarker criteria

Required: MS4A1 positive

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: immunochemotherapy

Prior therapy with at least one line of immunochemotherapy

Cannot have received: allogenic stem cell transplantation

Prior allogenic stem cell transplantation (SCT) or solid organ transplant

Cannot have received: solid organ transplant

Prior allogenic stem cell transplantation (SCT) or solid organ transplant

Cannot have received: lenalidomide (lenalidomide)

Prior treatment with lenalidomide

Cannot have received: CAR-T cell therapy

Exception: within 100 days of starting trial treatment

Treatment with CAR-T therapy within 100 days of starting trial treatment

Cannot have received: immunochemotherapy with a platinum-containing regimen

Exception: planned

Immunochemotherapy with a platinum-containing regimen planned

Cannot have received: experimental therapy under investigation

Prior treatment with the experimental therapy under investigation

Lab requirements

Blood counts

ANC ≥ 1.0 x 10^9/L (growth factor use is permitted); Platelet count ≥ 75 x 10^9/L, or ≥ 50 x 10^9/L if bone marrow infiltration or splenomegaly

Kidney function

CrCl ≥ 50mL/min (by Cockcroft-Gault formula)

Liver function

ALT and AST level ≤3 x ULN; Direct bilirubin level ≤ 2 x ULN, unless due to Gilbert's syndrome

Cardiac function

LVEF within normal limits by MUGA or echocardiography

Adequate organ function defined as; i. ANC ≥ 1.0 x 10^9/L (growth factor use is permitted) ii. Platelet count ≥ 75 x 10^9/L, or ≥ 50 x 10^9/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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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