NCT03506373 · OUTCOME

Biologic Effects of Ibrutinib and Ixazomib Citrate on Microenvironment in WM

Ibrutinib and Ixazomib Citrate in Treating Newly Diagnosed, Relapsed or Refractory Waldenstrom Macroglobulinemia · Source last updated 2026-05-05

This outcome was registered, but no numerical results were posted in the captured record.

Measure: Not reported
Unit: Not reported
Interval / dispersion: Not reported
Time frame: Up to 5 years

What was measured

Blood samples \& bone marrow aspirate to be taken from participants. The study will explore biologic effects of ibrutinib and ixazomib on microenvironment in WM and correlate with response to treatment. Immunophenotyping of tumor infiltrating lymphocytes (TILs) using the Multi-Omyx TILs platform. This will identify 17 different types of TILs from BM samples collected at baseline and then after one cycle of treatment. This data is represented as % and actual cell counts. Next, identification of 4 types of T-cells from the blood. This will be done from peripheral blood samples collected at Baseline and then after one cycle of treatment with ixazomib + ibrutinib (Ixa+Ibr). Next, BTK receptor occupancy: This is a competitive-binding assay essentially and will be performed in CD19+/CD138+ WM cells collected at baseline and then after one cycle of treatment with Ixa+Ibr. Readout is % occupancy. Values to be correlated with response (responder vs. non-responder) using Wilcoxon rank sum tests.

Groups in this outcome

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields

denom Units Selected: Participants
description: Blood samples \& bone marrow aspirate to be taken from participants. The study will explore biologic effects of ibrutinib and ixazomib on microenvironment in WM and correlate with response to treatment. Immunophenotyping of tumor infiltrating lymphocytes (TILs) using the Multi-Omyx TILs platform. This will identify 17 different types of TILs from BM samples collected at baseline and then after one cycle of treatment. This data is represented as % and actual cell counts. Next, identification of 4 types of T-cells from the blood. This will be done from peripheral blood samples collected at Baseline and then after one cycle of treatment with ixazomib + ibrutinib (Ixa+Ibr). Next, BTK receptor occupancy: This is a competitive-binding assay essentially and will be performed in CD19+/CD138+ WM cells collected at baseline and then after one cycle of treatment with Ixa+Ibr. Readout is % occupancy. Values to be correlated with response (responder vs. non-responder) using Wilcoxon rank sum tests.
reporting Status: NOT_POSTED
time Frame: Up to 5 years
title: Biologic Effects of Ibrutinib and Ixazomib Citrate on Microenvironment in WM
type: OTHER_PRE_SPECIFIED

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Preserved source evidence · Not medical advice