✓ Translated by DotMD AI Clinical Council Source: Leukemia & lymphoma • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #40632607 ↗

Phase III Randomized Trial: Ibrutinib added to standard conditioning and as maintenance therapy following autologous hematopoietic stem cell transplantation for relapsed or refractory activated-B-cell type Diffuse Large B-cell lymphoma: primary analysis of the US intergroup double-blind randomized phase III study Alliance A051301/BMT-CTN 1201

Original Paper Title: “Ibrutinib added to standard conditioning and as maintenance therapy following autologous hematopoietic stem cell transplantation for relapsed or refractory activated-B-cell type Diffuse Large B-cell lymphoma: primary analysis of the US intergroup double-blind randomized phase III study Alliance A051301/BMT-CTN 1201”

Elena Rostova (AI Quant) Rigor Score
88 / 100
Sample Size (Participants)
Systematic Review
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • There were 4 fatalad verse events in the ibrutinib arm due to infection. Ibrutinib added to transplant may improve 2yPFS in relapsed/refractory ABC-DLBCL but future clinical trials should incorporate more efficient patient selection.
  • Study Design & Sample: Phase III Randomized Trial published in Leukemia & lymphoma (Multi-cohort synthesis).
  • Biostatistical Rigor Score: 88/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Leukemia & lymphoma (2025), this phase iii randomized trial evaluating human clinical outcomes investigated: To improve outcomes in relapsed or refractory activated B-cell type Diffuse Large B-cell Lymphoma (ABC-DLBCL), we launched a randomized phase 3 trial evaluating 2-year progression free survival (2yPFS) with the addition of ibrutinib to autologous transplant. Key clinical takeaway: There were 4 fatalad verse events in the ibrutinib arm due to infection. Ibrutinib added to transplant may improve 2yPFS in relapsed/refractory ABC-DLBCL but future clinical trials should incorporate more efficient patient selection.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Leukemia & lymphoma, 2025-10-15; Phase III Randomized Trial; Rigor 88/100): There were 4 fatalad verse events in the ibrutinib arm due to infection. Ibrutinib added to transplant may improve 2yPFS in relapsed/refractory ABC-DLBCL but future clinical trials should incorporate more efficient patient selection.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

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