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Trial · NCT07882173

Epcoritamab as Consolidative Therapy for Waldenstr(SqrRoot)(Delta)m Macroglobulinemia (WM) Treated With a Bruton Tyrosine Kinase Inhibitor (BTKi)

NCT07882173, Phase 2, Not yet recruiting, National Heart, Lung, and Blood Institute (NHLBI)

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Epcoritamab as Consolidative Therapy for Waldenstr(SqrRoot)(Delta)m Macroglobulinemia (WM) Treated With a Bruton Tyrosine Kinase Inhibitor (BTKi). Trials, record NCT07882173. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07882173

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Epcoritamab as Consolidative Therapy for Waldenstr(SqrRoot)(Delta)m Macroglobulinemia (WM) Treated With a Bruton Tyrosine Kinase Inhibitor (BTKi)
NCT number
NCT07882173
Status
Not yet recruiting
Phases
Phase 2
Enrollment
24 participants, estimated
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Conditions
Waldenstrom Macroglobulinemia
Interventions
epcoritamab
First posted
2026-10-20
Last updated
2026-11-12

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryRate of complete remission (CR) or very good partial remission (VGPR)12 cycles (approximately 12 months after treatment begins)
CR: No detectable monoclonal IgM, normal bone marrow morphology with no lymphoplasmacytic lymphoma involvement, and resolution of any baseline extramedullary disease.VGPR: At least a 90% reduction in serum IgM from baseline or a serum IgM level within the normal range.
SecondaryOverall survival (OS)From the first dose of epcoritamab until death or up to 5 years after the first dose.Time from treatment initiation to death from any cause.
SecondaryDuration of response (DOR) after BTKi discontinuationAfter BTKi discontinuation until loss of response, progression, death, or initiation of subsequent therapy.The length of time that a confirmed CR or VGPR is maintained after BTKi therapy is discontinued.
SecondaryProgression-free survival (PFS)From the first dose of epcoritamab until progression or death.Time from treatment initiation to disease progression or death from any cause.
SecondaryTreatment-emergent adverse events (TEAEs)From the first dose of epcoritamab through 60 days after the last dose, or until new systemic anticancer therapy.Any new or worsened unfavorable medical occurrence after study treatment begins, regardless of whether it is considered treatment-related.
SecondaryIgM flareBaseline, during treatment, after treatment, and following BTKi discontinuation.Measured through serial serum IgM.
SecondaryImmune effector cell associated neurotoxicity syndrome (ICANS)From the first epcoritamab dose through treatment and safety follow-up, approximately 60 days after the last dose.ICANs will be assessed using the 10-point ICE tool.
SecondaryCytokine release syndrome (CRS)From the first epcoritamab dose through treatment and safety follow-up, approximately 60 days after the last dose.CRS will be graded using the ASTCT CRS criteria.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07882173

GET https://conductscience.org/api/trials/v1/NCT07882173/registered