Comparing two treatment combinations for Hodgkin Lymphoma patients resistant to Anti-PD-1 therapy
A Randomized, Open-label, Phase 2 Trial of Chidamide+Decitabine+Camrelizumab Versus Decitabine+Camrelizumab in Anti-PD-1 Antibody Resistant Patients With Classical Hodgkin Lymphoma.
This study is testing a new combination treatment for Hodgkin Lymphoma patients who didn't respond to previous therapy to see if it works better than the standard treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 12 Years to 75 Years |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Drugs / interventions | Camrelizumab |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04514081 on ClinicalTrials.gov |
What this trial studies
This open-label, randomized phase 2 trial aims to evaluate the effectiveness of a combination treatment involving Chidamide, Decitabine, and Camrelizumab against a control group receiving Decitabine and Camrelizumab. The study focuses on patients with classical Hodgkin Lymphoma who have shown resistance to Anti-PD-1 antibody therapy. Participants will be monitored for overall response rates to determine the efficacy of the new treatment regimen. The trial is designed to provide insights into alternative therapeutic options for this challenging patient population.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 12 to 75 with relapsed or refractory Hodgkin lymphoma who have previously received Anti-PD-1 antibody therapy and are confirmed resistant.
Not a fit: Patients with autoimmune diseases, serious uncontrolled medical disorders, or those who have had recent alimentary tract hemorrhage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new effective treatment option for patients with Hodgkin Lymphoma who are resistant to current therapies.
How similar studies have performed: While there is ongoing research in this area, the specific combination of Chidamide, Decitabine, and Camrelizumab in Anti-PD-1 resistant Hodgkin Lymphoma patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing
- Biotherapeutic Department of Chinese PLA General Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Weidong Han, M.D.
- Email: hanwdrsw@sina.com
- Phone: +861055499341
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.