Chidamide Decitabine Plus Anti-PD-1 Antibody for Patients With R/R cHL Who Are Transplant-ineligible or Refused Transplant.
NCT06393361 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-01-02
Summary
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 plus Anti-PD-1 Antibody in transplant-ineligible or refused transplant diagnosedR/R cHL. The primary objective of the study is to evaluate progression-free survival.
Conditions
- Ineligible Or Refused Transplant Patients With Classical Hodgkin Lymphoma
Interventions
- DRUG
-
Chidamide; Decitabine; Anti-PD-1 Antibody
Chidamide 10mg/day, day1-4; 20mg/day, day 8,11, 15, 18. Decitabine 10mg/day, day1-5. Physicians will decide which immune checkpoint inhibitors will be used during treatment.
- DRUG
-
Brentuximab Vedotin, anti-PD-1 antibody.
Brentuximab Vedotin 1.8mg/kg d1, anti-PD-1 antibody d1. Physicians will decide which immune checkpoint inhibitors will be used during treatment.
Sponsors & Collaborators
-
Chinese PLA General Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-01
- Primary Completion
- 2027-06-01
- Completion
- 2027-06-01
Countries
- China
Study Locations
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