This study is conducted on patients with relapsed or refractory Hodgkin lymphoma, a type of blood and lymphatic cancer that does not respond to initial treatments or recurs after therapy. The aim is to evaluate the efficacy and safety of a combination regimen of Gemcitabine + Vinorelbine with Pembrolizumab as a second-line treatment prior to stem cell transplantation.. Hodgkin lymphoma
Conditions
Interventions
.Intervention group: Patients with relapsed or refractory Hodgkin lymphoma receive a combination regimen of gemcitabine, vinorelbine, and pembrolizumab as second-line therapy.Gemcitabine is administer
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Confirmation of the diagnosis of classical Hodgkin lymphoma through biopsy History of unsuccessful initial treatment or disease recurrence ECOG performance status = 2 Normal or acceptable liver, kidney, and bone marrow function Written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Having active or chronic autoimmune diseases Serious active infection (such as HIV or uncontrolled hepatitis) Taking systemic immunosuppressive medications Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome:•Overall Response Rate (ORR): Percentage of patients achieving complete or partial response based on Lugano criteria, assessed after completion of treatment and before autologous stem cell transplantation.Secondary Outcomes:1.Complete Response Rate (CR rate): Percentage of patients achieving CR based on Lugano criteria, assessed after treatment.2.Partial Response Rate (PR rate): Percentage of patients achieving PR based on Lugano criteria, assessed after treatment.3.Incidence of adverse events: Percentage of patients experiencing treatment-related adverse events, graded according to CTCAE v5.0, during treatment.4.Incidence of grade =3 adverse events: Percentage of patients with grade 3 or higher toxicity (CTCAE v5.0).5.Progression-Free Survival (PFS)6.Overall Survival (OS). Timepoint: At baseline and at the end of treatment (3–4 weeks after the last chemotherapy cycle, prior to autologous stem cell transplantation). Method of measurement: Overall Response Rate: Computed tomography imaging and positron emission tomography imaging based on Lugano classification criteria for Hodgkin lymphoma /Complete Response Rate: Computed tomography imaging and positron emission tomography imaging based on Lugano classification criteria for Hodgkin lymphoma /Partial Response Rate: Computed tomography imaging and positron emission tomography imaging based on Lugano classification criteria for Hodgkin lymphoma /Incidence of adverse events: Clinical assessment based on Common Terminology Criteria for Adverse Events version five /Incidence of grade three or higher adverse events: Clinical assessment based on Common Terminology Criteria for Adverse Events version five /Progression-free survival: Clinical follow-up and imaging assessment /Overall survival: Follow-up of vital status of patients. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSara teihou jorshari
Iran University of Medical Sciences
Outcome results
None listed