CompletedPhase 3

Study of Bendamustine, Gemcitabine and Vinorelbine Regimen in Relapsed/Refractory Classical Hodgkin Lymphoma

Egypt88 participantsStarted 2024-04-30

Plain-language summary

The goal of this phase III clinical trial was to make a direct head to head comparison between the chemotherapeutics; Bendamustine, Gemcitabine and Vinorelbine (BEGEV) and the the Gemcitabine, Dexamethasone and Cisplatin (GDP) regimens in the settings of relapsed and refractory classical Hodgkin lymphoma. Patients were allocated and randomly assigned to either arm. Cycles were received as out-patient setting, every 21 days. Patients were assessed by clinical and routine labs, before receiving the cycle. Efficacy was assessed by performing Positron Emission Tomography (PET-CT) after three cycles. Toxicity was reported according to the National Cancer Institute Common Terminology Criteria of AEs v4.0 and was dealt with accordingly. Patients attained at least partial response (PR) was sent for high dose chemotherapy followed by autologous stem cell rescue(HDC/ASCR). Patients were followed up for a total of 1 year

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion Criteria: Primary refractory classical Hodgkin lymphoma Relapsed classical Hodgkin lymphoma Age 18 years old or more Both genders Eligible to receive the chemotherapeutic protocol. Exclusion Criteria: Eastern Cooperative Oncology Group(ECOG) performance status less than 2. Pregnancy. Second cancers. Chronic kidney disease End stage renal disease Liver cell failure HIV HCV HBV Autoimmune diseases

What they're measuring

Overall response rate

Timeframe: Six months

Trial details

NCT IDNCT07450508

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-30

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