Multicenter Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab, Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in Patients With Relapsed/Refractory Hodgkin Lymphoma

Launched by NATIONAL RESEARCH CENTER FOR HEMATOLOGY, RUSSIA · Dec 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with relapsed or refractory Hodgkin lymphoma, a type of cancer that affects the lymphatic system. The treatment being tested combines a medication called nivolumab with other drugs (Bendamustine, Gemcitabine, and Vinorelbine), aiming to improve the safety and effectiveness of care for patients who have not responded to previous treatments. The researchers want to see if this combination can help patients achieve better outcomes and possibly prepare them for a procedure called autologous stem cell transplantation, which can help restore healthy blood cells.

To participate in this study, patients need to be between 18 and 70 years old and have a confirmed diagnosis of Hodgkin lymphoma that has either come back or did not respond to initial treatment. They should also be generally healthy, with good heart function, and able to understand the study requirements. Participants can expect to receive close monitoring and support throughout the trial. It’s important to note that individuals with certain severe health issues or specific conditions may not be eligible to join the study. If you or someone you know is considering participation, it could be a valuable opportunity to access new treatments in a supportive environment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis: Histologically confirmed Hodgkins lymphoma
• • Relapsed or refractory disease after the first line of treatment
• • Age 18-70 years old
• • Ejection fraction greater than 50%
• • ECOG 0-2 status
• • Signed informed consent
• • No severe concurrent illness
• Exclusion Criteria:
• • Uncontrolled bacterial or fungal infection at the time of enrollment
• • Requirement for vasopressor support at the time of enrollment
• • Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms
• • Karnofsky index \<30%
• • Pregnancy
• • Somatic or psychiatric disorder making the patient unable to sign an informed consent
• • Active or prior documented autoimmune disease requiring systemic treatment.

Trial Officials