RECRUITINGPhase 2INTERVENTIONAL
Azacitidine Plus PD-1 Therapy for R/R Hodgkin Lymphoma
Azacitidine Plus PD-1 Therapy for Relapsed/Refractory Hodgkin Lymphoma
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Pathologically confirmed Hodgkin Lymphoma according World Health Organization (WHO) classification.
- Patient is ≥ 18 years of age at the time of signing the willing to sign a consent form 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 count at least 75 x 10\^9/L (≥ 50 x 10\^9/L if BM involvement by lymphoma); blood count (hemoglobin) at least 8 g/dL.
- Anticipated expected to live at least 3 months.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
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 (1)
Navy General Hospital
Beijing, Beijing Municipality, China