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

Refractory Classic Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06190067
• Other study ID #: PA2023
• Status: Recruiting
• Phase: Phase 2
• Start date: October 30, 2023
• Est. completion date: December 2028

Study information

• Verified date: January 2024
• Source: Navy General Hospital, Beijing
• Contact: Liren Qian, PhD
• Phone: +861066947192
• Email: qlr2007[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2028
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Refractory Classic Hodgkin Lymphoma

Intervention

Drug:
• Azacitidine 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

Country	Name	City	State
China	Navy General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Navy General Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	ORR was defined as the proportion of patients who achieved CR or PR as their best response	1 year
Secondary	Overall Survival (OS)	OS was defined as time from diagnosis to death from any cause or the last follow-up	through study completion, an average of 2 year
Secondary	Progression Free Survival (PFS)	PFS using local assessment of progressive disease according to Lugano Response Criteria (2014)	18 months