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Trial · NCT07365306

Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

NCT07365306, Phase 2, Recruiting, City of Hope Medical Center

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Trials, record NCT07365306. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07365306

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Trial

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

Title
Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
NCT number
NCT07365306
Status
Recruiting
Phases
Phase 2
Enrollment
43 participants, estimated
Lead sponsor
City of Hope Medical Center
Conditions
Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified, Recurrent Primary Mediastinal Large B-Cell Lymphoma, Recurrent Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Refractory High Grade B-Cell Lymphoma, Not Otherwise Specified, Refractory Primary Mediastinal Large B-Cell Lymphoma, Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma
Interventions
Autologous Hematopoietic Stem Cell Transplantation, Biopsy Procedure, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Epcoritamab, Gemcitabine, Oxaliplatin, Positron Emission Tomography, Rituximab
First posted
2026-01-26
Last updated
2026-08-28

Source ClinicalTrials.gov

Registered outcomes8

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

ListOutcomeTime frameDescription
PrimaryComplete response (CR)Up to 2 years
Defined as achieving a best response of CR during/after epcoritamab + rituximab, gemcitabine and oxaliplatin (R-GemOx) salvage therapy (prior to autologous stem cell transplantation \[ASCT\] or any non-protocol anti-lymphoma therapy) in a response-evaluable participant. Will be estimated by the binomial proportion along with the 95% exact binomial confidence interval
SecondaryOverall responseUp to 2 years
Defined as achieving a best response of CR or partial response (PR) during/after epcoritamab + R-GemOx salvage therapy (prior to ASCT or any non-protocol anti-lymphoma therapy) in a response-evaluable participant. Will be estimated by the binomial proportion along with the 95% exact binomial confidence interval.
SecondaryAbility to proceed to ASCTUp to 2 years
Defined as being able to proceed to and also receive an ASCT after epcoritamab + R-GemOx salvage therapy. Will be estimated by the binomial proportion along with the 95% exact binomial confidence interval.
SecondaryProgression-free survivalFrom start of protocol treatment to time of disease relapse/progression or death due to any cause, whichever occurs earlier, assessed up to 2 yearsWill be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation.
SecondaryDuration of response
From the time of first achieving CR/PR during/after epcoritamab + R-GemOx salvage therapy to time of disease relapse/progression or death due to any cause, whichever occurs earlier, assessed up to 2 yrs
Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation.
SecondaryOverall survivalTime in a participant from start of protocol treatment to time of death due to any cause, assessed up to 2 yearsWill be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation.
SecondaryStem cell mobilization failureUp to 2 years
Defined as failure to collect adequate CD34 stem cells (within 3 attempts) in a participant who attempt stem cell collection. Will be estimated by the binomial proportion along with the 95% exact binomial confidence interval.
SecondaryIncidence of adverse eventsUp to 2 years
Toxicities will be coded and collected per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, except that cytokine-release syndrome and Immune effector cell-associated neurological toxicity syndrome will be coded and collected per American Society for Transplantation and Cellular Therapy 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.

Grants1

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
P30CA033572Cancer Center Support GrantCARPTEN, JOHN D.BECKMAN RESEARCH INSTITUTE/CITY OF HOPENATIONAL CANCER INSTITUTE1985 to 2025

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.

Source

Release
trials-2026-11-12-0.4.0
Release manifest SHA-256
0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture
2026-11-12
Results copy, AACT
2026-03-23
NIH clinical studies file
2026-11-13

Source ClinicalTrials.gov

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone 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/NCT07365306

GET https://conductscience.org/api/trials/v1/NCT07365306/registered