RecruitingPhase 2NCT06393361

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


Sponsor

Chinese PLA General Hospital

Enrollment

100 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — chidamide (a targeted drug), decitabine (a type of chemotherapy), and an anti-PD-1 antibody (an immunotherapy) — in people with relapsed or treatment-resistant classical Hodgkin lymphoma who cannot have or have refused a stem cell transplant. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with classical Hodgkin lymphoma confirmed by biopsy - You have had at least 2 prior lines of treatment - You are not eligible for a stem cell transplant or have refused one - You have at least one measurable lymph node greater than 1 cm - Your liver, kidney, bone marrow, and heart function are adequate **You may NOT be eligible if...** - You have already received the specific combination of chidamide + decitabine + anti-PD-1 antibody, or brentuximab + anti-PD-1 antibody - You have an autoimmune disease requiring steroid treatment - You have active serious infections, especially lung infections - You have a history of serious gastrointestinal bleeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGChidamide; 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.

DRUGBrentuximab 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.


Locations(1)

Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital

Beijing, China

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NCT06393361