The Clinical Trial of Chidamide+Decitabine+Camrelizumab Versus Decitabine+Camrelizumab in Anti-PD-1 Antibody Resistant Patients With Classical Hodgkin Lymphoma.

Launched by CHINESE PLA GENERAL HOSPITAL · Aug 13, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a combination of three medications—Chidamide, Decitabine, and Camrelizumab—to see how well they work for patients with Hodgkin Lymphoma who have not responded to previous treatment with Anti-PD-1 antibodies. The trial aims to compare this new combination against a different treatment that includes Decitabine and Camrelizumab alone. It is designed for patients aged 12 to 75 who have been diagnosed with relapsed or refractory Hodgkin Lymphoma, meaning their cancer has either returned or has not improved with treatment. Participants should have at least one measurable tumor and must have confirmed resistance to Anti-PD-1 therapy.

If you or a loved one qualifies and decides to participate, you will receive the study medications and be closely monitored by healthcare professionals throughout the trial. It's important to note that certain health conditions, like autoimmune diseases or serious infections, may exclude someone from participating. The goal of this research is to find more effective treatments for patients who have limited options due to their resistance to previous therapies. Your participation could help advance our understanding of Hodgkin Lymphoma and improve future treatment options for others.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
• • 2. 12 to 75 years of age.
• • 3. ECOG performance of less than 2.
• • 4. Life expectancy of at least 3 months.
• • 5. Subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria.
• • 6. Subjects must have received Anti-PD-1 antibody therapy and were confirmed Anti-PD-1 antibody resistant. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.
• • 7. Subjects must have adequate marrow, live, renal and heart functions.
• Exclusion Criteria:
• • 1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
• • 2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
• • 3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month.
• • 4. Prior organ allograft.
• • 5. Women who are pregnant or breastfeeding.
• • 6. Women with a positive pregnancy test on enrollment or prior to investigational product administration.
• • 7. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.