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OncoMatch/Clinical Trials/NCT04587687

Brentuximab Vedotin and Bendamustine for the Treatment of Relapsed or Refractory Follicular Lymphoma

Is NCT04587687 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Bendamustine Hydrochloride and Brentuximab Vedotin for recurrent follicular lymphoma.

Phase 2RecruitingJoseph TuscanoNCT04587687Data as of May 2026

Treatment: Bendamustine Hydrochloride · Brentuximab VedotinThis phase II trial investigates how well brentuximab vedotin and bendamustine work in treating patients with follicular lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. Chemotherapy drugs, such as bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial is being done to determine if the combination of brentuximab vedotin plus bendamustine is safe and to determine the effectiveness of the combination.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Biomarker criteria

Required: TNFRSF8 expression >1% (>1% (tumor cells or surrounding peripheral microenvironment))

follicular CD30+ non-Hodgkin lymphoma (NHL)... CD30 positivity > 1% (tumor cells or surrounding peripheral microenvironment)

Performance status

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

Prior therapy

Min 1 prior line

Must have received:

Relapsed or refractory disease after at least 1 prior regimen, defined using the 2014 Lugano classification

Cannot have received: bendamustine (bendamustine)

Exception: allowed if no progression within 6 months of receiving treatment

Prior therapy with bendamustine or a bendamustine-containing regimens with progression within 6 months of receiving treatment

Lab requirements

Blood counts

Leukocytes >= 2,500/mcL; Absolute neutrophil count >= 1,000/mcL; Platelets >= 50,000/mcL; Hemoglobin >= 8 g/dL

Kidney function

Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault

Liver function

Total bilirubin <= 1.5 x ULN (<= 3 x ULN for Gilbert disease); AST/ALT <= 3 x ULN (<= 5 x ULN for patients with liver involvement); Alkaline phosphatase <= 2.5 x ULN (<= 5 x ULN for patients with documented liver involvement or bone metastases)

Leukocytes >= 2,500/mcL; Absolute neutrophil count >= 1,000/mcL; Platelets >= 50,000/mcL; Hemoglobin >= 8 g/dL; Total bilirubin <= 1.5 x ULN (however, patients with known Gilbert disease who have serum bilirubin level <= 3 x ULN may be enrolled); AST/ALT <= 3 x ULN (<= 5 x ULN for patients with liver involvement); Alkaline phosphatase <= 2.5 x ULN (<= 5 x ULN for patients with documented liver involvement or bone metastases); Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault

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

US trial sites

  • University of California Davis Comprehensive Cancer Center · Sacramento, California

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