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.
The prognosis of refractory or early-relapsed lymphoma is poor, and it is even worse for those who are not eligible or refuse transplantation. Although many salvage regimens have been developed, there is no standard of care. Preliminary clinical observations have shown that Chidamide +Decitabine plus Anti-PD-1 Antibody might be beneficial for these patients. Brentuximab Vedotin plus Anti-PD-1 Antibody is a standard regimen . 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 patients with classical Hodgkin lymphoma who are transplant-ineligible or refused transplant . The primary objective of the study is to evaluate the progression free survival.The key secondary end points are complete response rate, objective response rate and the safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
Brentuximab Vedotin 1.8mg/kg d1, anti-PD-1 antibody d1. Physicians will decide which immune checkpoint inhibitors will be used during treatment.
Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital
Beijing, China
RECRUITING1-year progression-free survival (PFS) rate
The proportion of patients who do not documented disease progression or death for a year from the date of first administration of the study drug.
Time frame: 12 months
Complete response rate (CRR)
CRR assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects
Time frame: 12 months
Objective response rate (ORR)
The percentage of patients with CR or PR was determined according to the revised lymphoma efficacy evaluation criteria (Lugano 2014 criteria).
Time frame: 12 months
Number of Subjects with treatment-related adverse events (AEs)
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
Time frame: 12 months
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