CompletedPhase 2

Study of Brentuximab Vedotin in Patients With R/R PTCL Treated With Gemcitabine

Belgium71 participantsStarted 2018-04-10

Plain-language summary

This study is an open label, multicenter phase 2 study. The primary objective of the study is to determine the efficacy of brentuximab vedotin in patients treated by gemcitabine for relapsed or refractory peripheral T-cell lymphoma in term of overall response rate assessed after 4 cycles of treatment according to the international response criteria for malignant lymphoma (Lugano Classification 2014 - CT-Based Response).

Who can participate

Age range18 Years – 80 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.

Exclusion criteria

✕. Absolute neutrophil count (ANC) \< 1500 cells/mm3 (1.5 x 109/L);
✕. Platelet count \<75,000/mm3 (75 x 109/L);
✕. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3.0 x upper limit of normal (ULN). AST or ALT may be elevated up to 5 x ULN if their elevation can be ascribed to the presence of hematologic/solid tumor in the liver;
✕. Serum total bilirubin \> 1.5 x ULN;
✕. Serum lipase level \> 2 x ULN;
✕. Serum creatinine \> 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance \< 40 mL/minute;
✕. Hemoglobin \< 8g/dL;
✕. Myocardial infarction within 2 years of enrollment

What they're measuring

Overall Response Rate (ORR)

Timeframe: 16 weeks = 4 cycles or permanent treatment discontinuation

Trial details

NCT IDNCT03496779

SponsorThe Lymphoma Academic Research Organisation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01-31

View on ClinicalTrials.gov More Refractory Peripheral T-Cell Lymphoma trials