Clinical trial · Interventional
Chidamide+Decitabine Plus Anti-PD-1 Antibody for Patients With R/R cHL Who Are Transplant-ineligible or Refused 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The prognosis for patients with relapsed/refractory classical Hodgkin lymphoma (cHL) who refuse or are ineligible for transplant is poor. This open label, randomized, phase 2 study aims to evaluate the efficacy of Chidamide+Decitabine plus Anti-PD-1 Antibody and Brentuximab Vedotin + Bendamustine plus Anti-PD-1 Antibody in transplant-ineligible or refused transplant diagnosed R/R cHL. The primary objective of the study is to evaluate progression-free survival.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ineligible Or Refused Transplant Patients With Classical Hodgkin Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brentuximab Vedotin+ Bendamustine+Anti-PD-1 antibody | Drug | — | UNRESOLVED |
| Chidamide; Decitabine; Anti-PD-1 Antibody | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chidamide+Decitabine+ Anti-PD-1 Antibody
- description
- Chidamide is a novel and orally active benzamide class of HDAC inhibitor that selectively inhibits activity of HDAC1, 2, 3 and 10, which can Induce tumor-cell apoptosis, suppress cell proliferation and enhance immune surveillance. Decitabine is an investigational (experimental) drug that works by depleting DNA methyltransferase 1(DNMT1), which can increase tumor antigens and HLA expression, enhances antigen processing, promotes T cell infiltration, and boosts effector T cell function. Immune checkpoint inhibitors have emerged as effective therapies for many cancers by promoting the reactivation and restoring function of T cells.
- interventionNames
- Drug: Chidamide; Decitabine; Anti-PD-1 Antibody
- type
- ACTIVE_COMPARATOR
- label
- Brentuximab Vedotin+ Bendamustine+anti-PD-1 antibody
- interventionNames
- Drug: Brentuximab Vedotin+ Bendamustine+Anti-PD-1 antibody
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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 Brentuximab Vedotin + Bendamustine Plus 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. \-
References
Publications (0)
Data not yet available