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NCT02443077 · ClinicalTrials.gov record · last posted 2026-07-31

Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

StatusActive, Not Recruiting
PhasePhase 3
Started2016-10-12
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 585 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 585 times since 2015-05-11; most recent amendment 2026-06-27. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2022-12-21
Status change Recruiting→Active, Not Recruitingv523
2019-10-03
Status change Suspended→Recruitingv223
2018-12-14
Status change Recruiting→Suspendedv179
2016-09-23
Status change Not Yet Recruiting→Recruitingv18
Trial Details
NCT Number NCT02443077
Lead Sponsor National Cancer Institute (NCI)
Conditions Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type, Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type
Enrollment 94 participants
Start Date 2016-10-12
Primary Completion 2024-06-10 (estimated)
Study Completion 2026-12-23 (estimated)
Updated on ClinicalTrials.gov 2026-07-31