Ineligible Or Refused Transplant Patients With Classical Hodgkin Lymphoma
Conditions
Brief 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.
Detailed description
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.
Interventions
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.
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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). 4. Patients must have at least two lines of antitumor therapy, those who were transplant-ineligible or refused transplant. 5.Life expectancy of at least 3 months. 6.Subjects with lymphoma must have at least one measureable lesion \>1cm as defined by lymphoma response criteria. 7. Previous treatment must be completed for more than 4 weeks prior to the enrollment of this study, and subjects have recovered to ≤ grade 1 toxicity. 8.Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. 9.Subjects must have adequate marrow, live, renal and heart functions.
Exclusion criteria
1\. Subjects have received the combination therapy of Chidamide+Decitabine and anti-PD-1 antibody or BV+ anti-PD-1 antibody.2.Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. 3. Serious uncontrolled medical disorders or active infections, pulmonary infection especially. 4. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month. 5. Prior organ allograft. 6. Women who are pregnant or breastfeeding. 7. Women with a positive pregnancy test on enrollment or prior to investigational product administration. 8. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year progression-free survival (PFS) rate | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate (CRR) | 12 months | CRR assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects |
| Objective response rate (ORR) | 12 months | The percentage of patients with CR or PR was determined according to the revised lymphoma efficacy evaluation criteria (Lugano 2014 criteria). |
| Number of Subjects with treatment-related adverse events (AEs) | 12 months | Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers predictive of efficacy and toxicity | 12 months | Biomarkers such as PD-1 from tumor tissue and peripheral blood will be assessed for their potential in predicting clinical efficacy and toxicity. |
Countries
China
Contacts
Primary ContactHan wei dong
Outcome results
None listed