Clinical trial · Interventional
The Clinical Trial of Chidamide+Decitabine+Camrelizumab Versus Decitabine+Camrelizumab in Anti-PD-1 Antibody Resistant Patients With Classical Hodgkin Lymphoma.
A Randomized, Open-label, Phase 2 Trial of Chidamide+Decitabine+Camrelizumab Versus Decitabine+Camrelizumab in Anti-PD-1 Antibody Resistant Patients With Classical Hodgkin Lymphoma.
NCT04514081CI-TRIAL-00046673unknownPhase 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 open-label, randomized, two-arm, phase 2 study has the primary objective of comparing the ORR obtained with Chidamide+Decitabine+Camrelizumab against that obtained with Decitabine+Camrelizumab in patients with Hodgkin Lymphoma who were confirmed resistant to Anti-PD-1 antibody therapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anti-PD-1 Antibody Resistant | — | UNRESOLVED | — |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide; Decitabine; Camrelizumab | Drug | — | UNRESOLVED |
| Decitabine+Camrelizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chidamide+Decitabine+Camrelizumab
- interventionNames
- Drug: Chidamide; Decitabine; Camrelizumab
- type
- ACTIVE_COMPARATOR
- label
- Decitabine+Camrelizumab
- interventionNames
- Drug: Decitabine+Camrelizumab
Primary outcomes (2)
- measure
- ORR assess by investigators per the 2014 Lugano classification
- timeFrame
- 3 years
- description
- rate of subjects achieved objective response in all evaluable subjects
- measure
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 have received Anti-PD-1 antibody therapy and were confirmed Anti-PD-1 antibody resistant. 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 1 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 illness.
References
Publications (0)
Data not yet available
No reference posted for this study.