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

NCT ID: NCT06190067

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-30

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Relapsed Classic Hodgkin Lymphoma Refractory Classic Hodgkin Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Azacitidine Plus PD-1 therapy

Patients were treated by Azacitidine plus PD-1 therapy

Group Type EXPERIMENTAL

Azacitidine Plus PD-1 therapy

Intervention Type DRUG

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

Interventions

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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)

Intervention Type DRUG

Other Intervention Names

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Azacitidine Plus PD-1 antibody

Eligibility Criteria

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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.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Navy General Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Liren Qian

Vice Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liren Qian, PhD

Role: PRINCIPAL_INVESTIGATOR

Navy General Hospital, Beijing

Locations

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Navy General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liren Qian, PhD

Role: CONTACT

+861066947192

Facility Contacts

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Liren Qian, M.D.

Role: primary

+861066957676

Other Identifiers

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PA2023

Identifier Type: -

Identifier Source: org_study_id

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