Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
| Condition | Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type, Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type |
|---|---|
| Phase | Phase 3 |
| Sponsor | National Cancer Institute (NCI) |
| Status | Active, not recruiting |
| Enrollment | 94 participants |
| Interventions | Autologous Bone Marrow Transplantation, Autologous Hematopoietic Stem Cell Transplantation, Carmustine, Cyclophosphamide, Cytarabine |
| Start date | Oct 12, 2016 |
| Completion date | Jun 10, 2024 |
| Results posted | Sep 30, 2025 |
Summary
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 |
Open in BENITIONS View on ClinicalTrials.gov
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