Azacitidine Plus PD-1 Therapy for R/R Hodgkin Lymphoma

Navy General Hospital, Beijing

Status and phase: Enrolling; Phase 2

Conditions: Relapsed Classic Hodgkin Lymphoma; Refractory Classic Hodgkin Lymphoma

Treatments: Drug: Azacitidine Plus PD-1 therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06190067

PA2023

Details and patient eligibility

About

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.

Full 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 lymphoma.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Azacitidine Plus PD-1 therapy

Experimental group

Description:

Patients were treated by Azacitidine plus PD-1 therapy

Treatment:

Drug: Azacitidine Plus PD-1 therapy