Combining azacitidine with PD-1 therapy for treating relapsed Hodgkin lymphoma
Azacitidine Plus PD-1 Therapy for Relapsed/Refractory Hodgkin Lymphoma
This study is testing whether combining azacitidine with PD-1 therapy can help people with relapsed Hodgkin lymphoma feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Navy General Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06190067 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with pathologically confirmed relapsed or refractory classic Hodgkin lymphoma who have undergone at least one line of systemic therapy.
Not a fit: Patients who have not been diagnosed with Hodgkin lymphoma or those who have not received prior systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with relapsed or refractory Hodgkin lymphoma.
How similar studies have performed: While this approach is innovative, similar studies combining immunotherapy with other agents have shown promise in treating various cancers, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.