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

NCT06190067 | Recruiting Phase 2

• 1 other identifier: PA2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsed Classic Hodgkin Lymphoma; Refractory Classic Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR was defined as the proportion of patients who achieved CR or PR as their best response

  1 year

Secondary Outcomes (2)

• Overall Survival (OS)

  through study completion, an average of 2 year

• Progression Free Survival (PFS)

  18 months

Study Arms (1)

Azacitidine Plus PD-1 therapy

EXPERIMENTAL

Patients were treated by Azacitidine plus PD-1 therapy

Drug: Azacitidine Plus PD-1 therapy

Interventions

Azacitidine Plus PD-1 therapy DRUG

Patients were treated by Azacytidine(75 mg/m2 subcutaneous injection qd on days 1-7) plus PD-1 therapy(200mg iv qd d8)

Also known as: Azacitidine Plus PD-1 antibody

Azacitidine Plus PD-1 therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• Navy General Hospital, Beijing: lead

Study Sites (1)

Navy General Hospital

Beijing, Beijing Municipality, 100048, China

RECRUITING

MeSH Terms

Interventions

Azacitidine

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Liren Qian, PhD

  Navy General Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liren Qian, PhD

CONTACT

+861066947192; qlr2007@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: October 30, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

CN (1)