Trial · NCT07108998
Study of Epcoritamab as a Consolidation Therapy in CLL/SLL
NCT07108998, Phase 2, Recruiting, Zulfa Omer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Epcoritamab as a Consolidation Therapy in CLL/SLL. Trials, record NCT07108998. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07108998
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Epcoritamab as a Consolidation Therapy in CLL/SLL
- NCT number
- NCT07108998
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 22 participants, estimated
- Lead sponsor
- Zulfa Omer
- Conditions
- CLL/SLL, CLL, SLL, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Small Lymphocytic Lymphoma Variant, Chronic Lymphocytic Leukemia Variants
- Interventions
- Epcoritamab
- First posted
- 2025-08-07
- Last updated
- 2026-01-06
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
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.
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/NCT07108998
GET https://conductscience.org/api/trials/v1/NCT07108998/registered