NCT06190067 Azacitidine Plus PD-1 Therapy for R/R Hodgkin Lymphoma
| NCT ID | NCT06190067 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Navy General Hospital, Beijing |
| Condition | Relapsed Classic Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-10-30 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2023-10-30 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Liren Qian, PhD
PRINCIPAL INVESTIGATOR
Navy General Hospital, Beijing
Frequently Asked Questions
Who can join the NCT06190067 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed Classic Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06190067 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06190067 currently recruiting?
Yes, NCT06190067 is actively recruiting participants. Contact the research team at qlr2007@126.com for enrollment information.
Where is the NCT06190067 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06190067 clinical trial?
NCT06190067 is sponsored by Navy General Hospital, Beijing. The principal investigator is Liren Qian, PhD at Navy General Hospital, Beijing. The trial plans to enroll 40 participants.