Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
| 対象疾患 | Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type, Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type |
|---|---|
| 相 | 第3相 |
| スポンサー | National Cancer Institute (NCI) |
| ステータス | 実施中（募集終了） |
| 参加者数 | 94 名 |
| 介入（薬剤） | Autologous Bone Marrow Transplantation, Autologous Hematopoietic Stem Cell Transplantation, Carmustine, Cyclophosphamide, Cytarabine |
| 開始日 | 2016年10月12日 |
| 完了日 | 2024年6月10日 |
| 結果公開日 | 2025年9月30日 |
概要
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 |
BENITIONS で見る ClinicalTrials.gov の原文を見る
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