Status:
RECRUITING
Azacitidine Plus PD-1 Therapy for R/R Hodgkin Lymphoma
Lead Sponsor:
Navy General Hospital, Beijing
Conditions:
Relapsed Classic Hodgkin Lymphoma
Refractory Classic Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity of azacytidine combined with PD-1 therapy in classic relapsed/refractory Hodgkin lym...
Eligibility Criteria
Inclusion
- 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.
- Relapsed (after partial or complete response) or refractory AITL after at least one line of systemic therapy (there is no mandatory resting period after the previous treatment as long as the biochemistry and hematology labs meet the inclusion criteria as below).
- 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
- 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.
Key Trial Info
Start Date :
October 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06190067
Start Date
October 30 2023
End Date
December 1 2028
Last Update
January 30 2024
Active Locations (1)
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1
Navy General Hospital
Beijing, Beijing Municipality, China, 100048