Combining chidamide and decitabine for relapsed Non-Hodgkin's lymphoma after CAR T-cell therapy
Chidamide in Combination With Decitabine in Non-Hodgkin's Lymphoma Relapsed After Chimeric Antigen Receptor : An Open-label Phase I/II Trial
This study is testing if combining two drugs, chidamide and decitabine, can help people with Non-Hodgkin's lymphoma who have had a relapse after CAR T-cell therapy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Drugs / interventions | chimeric antigen receptor |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04337606 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of chidamide in combination with decitabine for patients with relapsed Non-Hodgkin's lymphoma following chimeric antigen receptor T-cell infusion. It is a Phase I/II study that aims to determine how well this combination therapy works in this specific patient population. Participants must have measurable disease and meet specific health criteria to be eligible for the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with histologically confirmed Non-Hodgkin lymphoma who have relapsed after CAR T-cell infusion.
Not a fit: Patients with autoimmune diseases, serious uncontrolled medical disorders, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with relapsed Non-Hodgkin's lymphoma after CAR T-cell therapy.
How similar studies have performed: While there have been studies on CAR T-cell therapy and various combinations for lymphoma, this specific combination of chidamide and decitabine is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects must have histological confirmation of Non-Hodgkin lymphoma (NHL) and relapsed after chimeric antigen receptor T cells infusion. 2. 18 to 65 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 new lesion \>1.5cm as defined by lymphoma response criteria. 6. Subjects must have relapsed after chimeric antigen receptor T cells infusion without any intervention treatment prior to Day 1. 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 one 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 (eg, infectious disease) illness
Where this trial is running
Beijing, Beijing
- Biotherapeutic Department of Chinese PLA General Hospital — Beijing, Beijing, China (Recruiting)
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.