Clinical trial · Interventional
Addition of Chidamide to the Combination Treatment of Decitabine Plus Camrelizumab in Combination Treatment Resistant/Relapsed Patients With Classical Hodgkin Lymphoma
Addition of Chidamide to the Combination Treatment of Decitabine Plus Camrelizumab in Combination Treatment Resistant/Relapsed Patients With Classical Hodgkin Lymphoma: an Open-label, Single Arm, Phase II Trial
NCT04233294CI-TRIAL-00046642unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a Phase II clinical trial for Decitabine plus Camrelizumab resistant/relapsed patients with Hodgkin Lymphoma. The purpose is to evaluate the efficacy and safety of the combination therapy of Chidamide plus Decitabine Plus Camrelizumab.
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 |
|---|---|---|---|
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab | ALIAS |
| Chidamide | Drug | — | UNRESOLVED |
| Decitabine | Drug | Decitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- chidamide in combination with camrelizumab plus decitabine
- description
- chidamide 10mg/day, days 1-4, 20mg/day, day 8, 11, 15, 18; camrelizumab 200mg d6; decitabine 10 mg/day, days 1-5, every 3 weeks
- interventionNames
- Drug: Chidamide
- Drug: Camrelizumab
- Drug: Decitabine
Primary outcomes (2)
- measure
- ORR
- timeFrame
- 3 years
- description
- ORR assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects
- measure
- Adverse effects
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL). 2. 12 to 75 years of age. 3. ECOG performance of less than 2. 4. Life expectancy of at least 3 months. 5. Subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria. 6. Subjects must be relapsed or resistant for the treatment of Decitabine plus Camrelizumab. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. 7. Subjects must have adequate marrow, live, renal and heart functions. Exclusion Criteria: 1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. 2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially. 3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in one month . 4. Prior organ allograft. 5. Women who are pregnant or breastfeeding. 6. Women with a positive pregnancy test on enrollment or prior to investigational product administration. 7. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
References
Publications (1)
- DERIVEDNie J, Wang C, Zheng L, Liu Y, Wang C, Chang Y, Hu Y, Guo B, Pan Y, Yang Q, Hu X, Han W. Epigenetic agents plus anti-PD-1 reprogram the tumor microenvironment and restore antitumor efficacy in Hodgkin lymphoma. Blood. 2024 Oct 31;144(18):1936-1950. doi: 10.1182/blood.2024024487. PMID 39093981