Registered outcomes11

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

1 to 11 of 11

List	Outcome	Time frame	Description
Primary	uMRD CR as defined by negative leukemia cells to the 10^6	Post 12 cycles (approximately 336 days after the start of first cycle) of consolidative therapy with epcoritamab	uMRD CR as defined by negative leukemia cells to the 10\^6 after 12 cycles of consolidative therapy with epcoritamab measured by Adaptive's NGS MRD assay (ClonoSEQ) in patients who have attained a partial response or better with detectable disease after acalabrutinib or zanubrutinib +/- obinutuzumab treatment for a minimum of 12 cycles of therapy
Secondary	Safety measured by CTCAE v. 5.	Day 1 of Cycle 1 to 60 days after end of C12D28 (i.e., approximately 396 days after the start of intervention)	Safety of epcoritamab given together with acalabrutinib or zanubrutinib in patients with CLL/SLL reported as frequency and severity of adverse events using CTCAE v. 5.
Secondary	uMRD CR defined by negative leukemia cells to the 10^6 using NGG ClonoSEQ	Post 6 cycles (approximately 196 days after start of intervention) of consolidation with epcoritamab.	uMRD CR defined by negative leukemia cells to the 10\^6 using NGG ClonoSEQ after 6 cycles of consolidation with epcoritamab.
Secondary	T-cell subsets levels measured by flow-cytometry	Baseline, pre-treatment on Cycle1 Day 1, Cycle 1 Day 8, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 7 Day 1 and end of Cycle 12. Each cycle is 28 days.	T-cell subsets levels (include T-regulatory cells, TH17 T-cells, effector memory T-cells, central memory T-cells, naïve T-cells, and cytotoxic T-cells) at baseline, Day 1, Day 8, C2D1, C4D1, C7D1 and C12 D28 of consolidation with epcoritamab.
Secondary	PFS defined as the interval between the first treatment day to the first sign of disease progression or death from any cause of patient	Post 12 cycles of consolidative epcoritamab (approximately 364 days from start of intervention).. Each cycle is 28 days.	PFS defined as the interval between the first treatment day to the first sign of disease progression or death from any cause after receiving 12 cycles of consolidative epcoritamab.
Secondary	OS defined as time from starting treatment until death of patients	Post 12 cycles of consolidative epcoritamab (approximately 364 days from start of intervention).. Each cycle is 28 days.	OS defined as time from starting treatment until death of patients after receiving 12 cycles of consolidative epcoritamab.
Other	T-cell cytotoxicity against primary pretreatment CLL cells	Baseline, Day 1, Day 8, Day 29 of Cycle 1, end of Cycle 3, Cycle 6 and Cycle 12 of consolidation with epcoritamab. Each cycle is 28 days.	T-cell cytotoxicity against primary pretreatment CLL identified by INF-gamma production in presence of ex-vivo incubated CLL cells at baseline, Day 1, Day 8, Day 29 of Cycle 1, end of Cycle 3, Cycle 6 and Cycle 12 of consolidation with epcoritamab.
Other	T-cell proliferation against primary pretreatment CLL cells	Baseline, Day 1, Day 8, Day 29 of Cycle 1, end of Cycle 3, Cycle 6 and Cycle 12 of consolidation with epcoritamab. Each cycle is 28 days.	T-cell proliferation against primary pretreatment CLL cells through identifying different T cell cells receptor(TCR) using next generation sequencing at baseline, Day 1, Day 8, Day 29 of Cycle 1, end of Cycle 3, Cycle 6 and Cycle 12 of consolidation with epcoritamab.
Other	Cytokine production against autologous CLL cells	Baseline, Day 1, Day 8, Day 29 of Cycle 1, end of Cycle 3, Cycle 6 and Cycle 12 of consolidation with epcoritamab. Each cycle is 28 days.	Cytokine levels ( e.g. IL-6, TNF-alpha) produced using flow cytometry against CLL cells at baseline, Day 1, Day 8, Day 29 of Cycle 1, end of Cycle 3, Cycle 6 and Cycle 12 of consolidation with epcoritamab.
Other	Tumor features of patients who respond to epcoritamab therapy and then relapse following receipt of this treatment.	Screening, Baseline pre-treatment on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, end of Cycle 12 (or at EOT) and Relapse. Each cycle is 28 days.	To determine pre-treatment and serial tumor features changes including development of new mutations and change in genomics through whole exon sequencing and single cell sequecning that are associated with response in CLL patients receiving epcoritamab at the following timepoints Screening, Baseline pre-treatment on C1D1, C1D8, C2D1, C4D1, C7D1, end of C12 (or at EOT) and Relapse.
Other	Pre-treatment and serial findings associated with CRS in CLL patients receiving epcoritamab.	Cycle 1 Day 1, Cycle 1 Day 8, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, end of Cycle 12. Each cycle is 28 days.	To determine pre-treatment and serial levels of ferritin, soluble CD163 , IL-6, IFN-gamma through flow-cytometry that are associated with CRS in CLL patients receiving epcoritamab through measurement of INF gamma production.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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