Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
| 대상 질환 | Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type, Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type |
|---|---|
| 임상 단계 | 3상 |
| 스폰서 | National Cancer Institute (NCI) |
| 상태 | 진행 중(모집 완료) |
| 참여자 수 | 94 명 |
| 중재(약물) | Autologous Bone Marrow Transplantation, Autologous Hematopoietic Stem Cell Transplantation, Carmustine, Cyclophosphamide, Cytarabine |
| 시작일 | 2016년 10월 12일 |
| 완료일 | 2024년 6월 10일 |
| 결과 공개일 | 2025년 9월 30일 |
요약
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 |
BENITIONS에서 보기 ClinicalTrials.gov 원문 보기
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