Azacitidine Plus PD-1 Therapy for R/R Hodgkin Lymphoma
Recruiting now · Phase 2
Conditions studied: Relapsed Classic Hodgkin Lymphoma, Refractory Classic Hodgkin Lymphoma
In brief
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.
Key facts
- Study ID
- NCT06190067
- Run by
- Navy General Hospital, Beijing
- People needed
- 40
- Starts
- 2023-10-30
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2024-01-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Navy General Hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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