Azacitidine Plus PD-1 Therapy for Relapsed/Refractory Hodgkin Lymphoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Navy General Hospital
RECRUITING
Beijing
Contact Information
Primary
Liren Qian, PhD
qlr2007@126.com
+861066947192
Time Frame
Start Date: 2023-10-30
Estimated Completion Date: 2028-12
Participants
Target number of participants: 40
Treatments
Experimental: Azacitidine Plus PD-1 therapy
Patients were treated by Azacitidine plus PD-1 therapy
Related Therapeutic Areas
Sponsors
Leads: Navy General Hospital, Beijing

This content was sourced from clinicaltrials.gov