CNS-Relapse Prevention in High-Risk Diffuse Large B-cell Lymphoma With Thiotepa-based Auto
A serious consequence of systemic diffuse large B-cell lymphoma (DLBCL) is secondary central nervous system (CNS) relapse, which occurs in approximately 5% of all patients. Many CNS relapses occur within the first year after completion of frontline treatment and are associated with significantly increased mortality; th
| Condition(s) | Diffuse Large B Cell Lymphoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | A serious consequence of systemic diffuse large B-cell lymphoma (DLBCL) is secondary central nervous system (CNS) relapse, which occurs in approximately 5% of all patients. Many CNS relapses occur within the first year after completion of frontline treatment and are associated with significantly increased mortality; thus, it is important to tailor frontline treatment to provide prophylaxis against CNS relapse in those patients who are determined to be high-risk. Autologous stem cell transplantation (ASCT) is standard of care for patients with DLBCL who relapse one year or more after first remission, and it has been shown to improve progression-free survival for patients with primary CNS lymphoma. The four-drug BEAM regimen (carmustine, etoposide, cytarabine, and melphalan) is the preferred |
| Who can participate | Screening Inclusion Criteria: * Newly diagnosed diffuse large B-cell lymphoma, large B-cell lymphoma transformed from underlying indolent lymphoma, or high-grade B-cell lymphoma. Patients with secondary CNS lymphoma are eligible. Patients with Richter's transformation are NOT eligible. * At high risk for CNS relapse prior to start of induction as defined by at least one of the criteria below: * CNS-IPI ≥ 4 * Kidney or adrenal involvement * Testicular involvement * Breast involvement * Ovarian involvement * Uterine involvement * Skin involvement * Double hit lymphoma as defined by containing translocations of MYC gene together with rearrangement of BCL2 and/or BCL6. * Bone marrow involvement * Myocardium involvement * CNS adjacent * Secondary CNS involvement * Intend to receive a full cours |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Washington University School of Medicine |
| Locations | St Louis, Missouri, United States |
| Start date | 2025-01-16 |
| NCT ID | NCT06687772 |
| Official listing | https://clinicaltrials.gov/study/NCT06687772 |