Study of Bendamustine, Gemcitabine and Vinorelbine Regimen in Relapsed/Refractory Classical Hodgk… (NCT07450508) | Clinical Trial Compass
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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a combination of bendamustine, gemcitabine, and vinorelbine for relapsed or refractory classical Hodgkin lymphoma — is this specific three-drug combination something you'd consider for my situation, and how does its overall response rate compare to what I might expect from other salvage regimens you'd recommend?
2Since this was a Phase 3 trial and recruitment is now completed, does that mean results are available, and if so, what did the data show about how well this regimen worked and what side effects patients experienced?
3How does the BGV regimen tested in this trial compare to standard salvage chemotherapy options like ICE or DHAP that are often used before a stem cell transplant — would one approach be more appropriate for me?
4Because this trial enrolled people with relapsed or refractory classical Hodgkin lymphoma specifically, how does my own relapse history and prior treatments affect whether this regimen would even be a reasonable option to discuss for my care?
5Given that the trial is completed and no longer enrolling, are there any currently open trials or expanded access programs studying similar combinations that might be worth exploring alongside standard treatment options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.