Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
| 适应症 | Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type, Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type |
|---|---|
| 分期 | 3期 |
| 申办方 | National Cancer Institute (NCI) |
| 状态 | 进行中（已停止招募） |
| 受试者人数 | 94 人 |
| 干预（药物） | Autologous Bone Marrow Transplantation, Autologous Hematopoietic Stem Cell Transplantation, Carmustine, Cyclophosphamide, Cytarabine |
| 开始日期 | 2016年10月12日 |
| 完成日期 | 2024年6月10日 |
| 结果公布日 | 2025年9月30日 |
摘要
This randomized phase III trial studies ibrutinib to see how well it works compared to placebo when given before and after stem cell transplant in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Before transplant, stem cells are taken from patients and stored. Patients then receive high doses of chemotherapy to kill cancer cells and make room for healthy cells. After treatment, the stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Ibrutinib is a drug that may stop the growth of cancer cells by blocking a protein that is needed for cell growth. It is not yet known whether adding ibrutinib to chemotherapy before and after stem cell transplant may help the transplant work better in patients with relapsed or refractory diffuse large B-cell lymphoma.
24-month Progression-free Survival (PFS), Defined as the Proportion of Patients Who Are Alive and Progression-free 2 Years From Randomization
| Arm I (Ibrutinib, Chemotherapy, autoHCT) | 0.576 proportion of participants |
|---|---|
| Arm II (Placebo, Chemotherapy, autoHCT) | 0.408 proportion of participants |
在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文
同一适应症的其他试验
- A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Ve — Hoffmann-La Roche
- Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diag — National Cancer Institute (NCI)
- Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating — National Cancer Institute (NCI)
- Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Tr — National Cancer Institute (NCI)
- Testing the Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibruti — National Cancer Institute (NCI)
- An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymph — Acerta Pharma BV