Combination treatment for patients with relapsed classical Hodgkin lymphoma who can't undergo transplant
Official title: A Randomized, Open-label, Phase 2 Trial of Chidamide+Decitabine Plus Anti- PD-1 Antibody for Patients With R/R cHL Who Are Transplant-ineligible or Refused Transplant
Run by Chinese PLA General Hospital · NCT06393361 · Data updated 2026-11-12
This study is testing a new combination treatment for patients with relapsed classical Hodgkin lymphoma who can't have a transplant to see if it helps them live longer without their cancer getting worse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Drugs / interventions | Brentuximab |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | June 1, 2024 |
| Main results expected | June 1, 2027 |
| Study ends | June 1, 2027 |
| Registry record updated | January 2, 2026 |
| Trial ID | NCT06393361 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 with histologically confirmed classical Hodgkin lymphoma who have received at least two lines of antitumor therapy and are either transplant-ineligible or have refused transplant.
✕Probably not a fit
Patients who have previously received the combination therapies being tested or those with autoimmune diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label, randomized phase 2 study evaluates the efficacy of Chidamide combined with Decitabine and an Anti-PD-1 antibody versus Brentuximab Vedotin combined with an Anti-PD-1 antibody in patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who are ineligible for or have refused transplantation. The primary objective is to assess progression-free survival, while secondary endpoints include complete response rate, objective response rate, and safety. The study aims to provide a new treatment option for patients with poor prognosis due to their transplant status.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with relapsed classical Hodgkin lymphoma who are not candidates for transplantation.
How similar studies have gone: While there have been various treatment approaches for classical Hodgkin lymphoma, this specific combination therapy is novel and has not been extensively tested in this patient population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1.18 to 75 years of age. 2.ECOG performance of less than 2. 3.Subjects must have histological confirmation classical Hodgkin lymphoma (cHL). 4. Patients must have at least two lines of antitumor therapy, those who were transplant-ineligible or refused transplant. 5.Life expectancy of at least 3 months. 6.Subjects with lymphoma must have at least one measureable lesion \>1cm as defined by lymphoma response criteria. 7. Previous treatment must be completed for more than 4 weeks prior to the enrollment of this study, and subjects have recovered to ≤ grade 1 toxicity. 8.Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. 9.Subjects must have adequate marrow, live, renal and heart functions. Exclusion Criteria: 1\. Subjects have received the combination therapy of Chidamide+Decitabine and anti-PD-1 antibody or BV+ anti-PD-1 antibody.2.Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. 3. Serious uncontrolled medical disorders or active infections, pulmonary infection especially. 4. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month. 5. Prior organ allograft. 6. Women who are pregnant or breastfeeding. 7. Women with a positive pregnancy test on enrollment or prior to investigational product administration. 8. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
Where it's running
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Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital
Beijing, China Recruiting
Study contacts
- Study coordinator: Han wei dong
- Email: hanwdrsw@sina.com
- Phone: +861055499341
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.