RecruitingPhase 2NCT06190067
Azacitidine Plus PD-1 Therapy for R/R Hodgkin Lymphoma
Azacitidine Plus PD-1 Therapy for Relapsed/Refractory Hodgkin Lymphoma
Sponsor
Navy General Hospital, Beijing
Enrollment
40 participants
Start Date
Oct 30, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
The goal of this phase 2 trial is to test the safety and efficacy of azacitidine when given together with PD-1 therapy in treating patients with relapsed/refractory classic Hodgkin lymphoma.
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- Pathologically confirmed Hodgkin Lymphoma according World Health Organization (WHO) classification.
- Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
- Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted.
- Patient is willing and able to adhere to the study visit schedule and other protocol requirements.
- Meet the following lab criteria: Absolute Neutrophil Count (ANC) ≥ 1,5 x 10\^9/L (≥ 1 x 10\^9/L if bone marrow (BM) involvement by lymphoma); Platelet ≥ 75 x 10\^9/L (≥ 50 x 10\^9/L if BM involvement by lymphoma); Hemoglobin ≥ 8 g/dL.
- Anticipated life expectancy at least 3 months.
Exclusion Criteria3
- Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
- Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
- Pregnant or lactating women.
Interventions
DRUGAzacitidine Plus PD-1 therapy
Patients were treated by Azacytidine(75 mg/m2 subcutaneous injection qd on days 1-7) plus PD-1 therapy(200mg iv qd d8)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06190067
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