2024-08-22
minor
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Eligibility v2
Enrollment target60→100
InterventionsChidamide; Decitabine; Anti-PD-1 Antibody (Drug), Gemcitabine, Vinorelbine, Pegylated liposomal doxorubicin, Ifosfamide, Carboplatin…→Brentuximab Vedotin, anti-PD-1 antibody. (Drug), Chidamide; Decitabine; Anti-PD-1 Antibody (Drug)
Eligibility criteria-151 characters
Inclusion Criteria:
1.18 to 75 years of age.
2.ECOG performance of less than 2. 3.Subjects must have histological confirmation classical Hodgkin lymphoma (cHL).
24.18 toPatients 75must yearshave at least two lines of ageantitumor therapy, those who were transplant-ineligible or refused transplant.
3.ECOG performance of less than 2.
45.Life expectancy of at least 3 months.
56.Subjects with lymphoma must have at least one measureable lesion >1cm as defined by lymphoma response criteria.
67.Subjects mustPrevious have received Anti-PD-1 antibody therapy and were confirmed Anti-PD-1 antibody failur [...] [...]
Study description-263 characters
Anti-PD-1The antibody induces a high response rate in patients with relapsed/refractory classic Hodgkin lymphoma, but more than 60%prognosis of patientsrefractory 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 diseasebeen relapsedeveloped, orthere progressionis duringno orstandard afterof immune checkpoint inhibitors and subsequent salvage therapies could not meet the needcare.
Preliminary clinical observations have shown that Chidamide +Decitabine plus antiAnti-PD-1 antibodyAntibody might b [...] [...]
Study title+12 characters
Chidamide+Decitabine Plus Anti-PD-1 Antibody in PD-1 Inhibitor Failedfor Patients With ClassicalR/R HodgkincHL LymphomaWho Are Transplant-ineligible or Refused Transplant.
2024-06-09
notable
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-05-15→2026-06-01
Completion date2027-05-15→2027-06-01
Start dateestimated 2024-05-15→confirmed 2024-06-01
Study sites0→1
Eligibility criteria+149 characters
Inclusion Criteria:
1.Subjects must have histological confirmation classical Hodgkin lymphoma (cHL).
2.1218 to 75 years of age.
3.ECOG performance of less than 2.
4.Li [...] must have adequate marrow, live, renal and heart functions.
8.Patients who have received Chidamide+Decitabine+ immune checkpoint inhibitors can be directly assigned to the control group without randomization.
Exclusion Criteria:
Subjects with any autoimmune disease or [...]