Clinical Trial TitleA randomized double-blind phase III study of ibrutinib during and following autologous stem cell transplantation versus placebo in patients with relapsed or refractory diffuse large B-cell lymphoma of the activated B-cell subtype.
Clinical Trial Protocol Description:
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.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have tissue from the diagnostic or relapsed biopsy available to be submitted for central pathology review and integral molecular subtyping. This review is mandatory prior to registration to confirm eligibility and should be initiated as soon as possible. Determination of cell-of-origin subtype will be performed using the Lymphoma Subtyping Test (LST) assay.
- Are 18 years old or older.
- Have a diagnosis of diffuse large B-cell lymphoma (DLBCL) or a high grade B-cell lymphoma not otherwise specified.
- Have determination of ABC subtype DLBCL.
- Are eligible for high-dose chemotherapy and autologous stem cell transplant.
- Have disease that has progressed or is resistant to prior anthracycline-containing chemotherapy (R-CHOP, DA-EPOCH-R, etc.).
- Have received no more than 3 prior chemotherapy regimens.
- Have disease that is chemosensitive (must have had at least a partial response to chemotherapy).
You will be excluded from the study if any of the following criteria apply to you:
- Have active central nervous system or brain involvement by lymphoma.
- Have evidence of myelodysplasia.
- Have a known bleeding disorder.
- Have a requirement for warfarin or similar vitamin K antagonists.
This is a partial list of elgibility requirements.