Combining azacitidine with PD-1 therapy for treating relapsed Hodgkin lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial aims to evaluate the safety and efficacy of azacitidine in combination with PD-1 therapy for patients suffering from relapsed or refractory classic Hodgkin lymphoma. The study will assess key outcomes such as response rate, progression-free survival, overall survival, and the toxicity of the treatment regimen. Participants will undergo treatment and regular assessments to monitor their health and response to the therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Navy General Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Liren Qian, PhD — Navy General Hospital, Beijing
• Study coordinator: Liren Qian, PhD
• Email: qlr2007@126.com
• Phone: +861066947192

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.