Combination treatment for patients with relapsed classical Hodgkin lymphoma who can't undergo transplant

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

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
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (Academic / other)
• Drugs / interventions: Brentuximab
• Locations: 1 site (Beijing)
• Trial ID: NCT06393361 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients who have previously received the combination therapies being tested or those with autoimmune diseases may not benefit from this study.

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 performed: 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.

Eligibility 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 this trial is running

Beijing

• Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Han wei dong

Conditions Ineligible Or Refused Transplant Patients With Classical Hodgkin Lymphoma