Clinical trial · Interventional
Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
An Open-label, Multicenter, phase2/3 Study of Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
- 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 an open-label, Phase 2/3，multicenter and single-arm clinical trial of Camrelizumab plus decitabine for Anti-PD-1 treatment-naive patients with relapsed or refractory Hodgkin Lymphoma. The primary objective of this study is to evaluate the long-term response duration with Camrelizumab plus decitabine in relapsed or refractory Hodgkin Lymphoma.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab and Decitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Camrelizumab plus decitabine
- description
- Decitabine 10 mg/day, days 1-5; Camrelizumab 200 mg, day 8, every 3 weeks.
- interventionNames
- Drug: Camrelizumab and Decitabine
Primary outcomes (2)
- measure
- duration of response
- timeFrame
- 5 years
- description
- Time measured from the day of first documented PR or CR to the date of first documented progression, or death from any cause.
- measure
- Progression free survival
- timeFrame
- 5 years
- description
- Time measured from the day of treatment to the date of first documented progression, or death from any cause
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 at least two lines of prior regimens without Anti-PD-1 antibody treatment history, and must be off therapy for at least 4 weeks prior to Day 1. 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 nvestigational product administration. * 7 Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
References
Publications (0)
Data not yet available