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Trial Title:
Azacitidine Plus PD-1 Therapy for R/R Hodgkin Lymphoma
NCT ID:
NCT06190067
Condition:
Relapsed Classic Hodgkin Lymphoma
Refractory Classic Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Hodgkin Disease
Azacitidine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Azacitidine Plus PD-1 therapy
Description:
Patients were treated by Azacytidine(75 mg/m2 subcutaneous injection qd on days 1-7) plus
PD-1 therapy(200mg iv qd d8)
Arm group label:
Azacitidine Plus PD-1 therapy
Other name:
Azacitidine Plus PD-1 antibody
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Navy General Hospital
Address:
City:
Beijing
Zip:
100048
Country:
China
Status:
Recruiting
Contact:
Last name:
Liren Qian, M.D.
Phone:
+861066957676
Email:
qlr2007@126.com
Start date:
October 30, 2023
Completion date:
December 2028
Lead sponsor:
Agency:
Navy General Hospital, Beijing
Agency class:
Other
Source:
Navy General Hospital, Beijing
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06190067
