Trial · NCT07572123
Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem Cell Transplant Alone for High-risk Patients With Relapsed or Refractory Hodgkin Lymphoma
NCT07572123, Phase 2, Phase 3, Not yet recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem Cell Transplant Alone for High-risk Patients With Relapsed or Refractory Hodgkin Lymphoma. Trials, record NCT07572123. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07572123
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem Cell Transplant Alone for High-risk Patients With Relapsed or Refractory Hodgkin Lymphoma
- NCT number
- NCT07572123
- Status
- Not yet recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 374 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Classic Hodgkin Lymphoma, Refractory Classic Hodgkin Lymphoma
- Interventions
3-Dimensional Conformal Radiation Therapy, Autologous Hematopoietic Stem Cell Transplantation, Biospecimen Collection, Brentuximab Vedotin, Computed Tomography, High Dose Chemotherapy, Intensity-Modulated Radiation Therapy, Nivolumab, Pembrolizumab, Pencil Beam Scanning, Positron Emission Tomography, Salvage Therapy, Scattering Proton Beam Therapy, Tomotherapy, Uniform Active Scanning Proton Beam Therapy, Volume Modulated Arc Therapy
- First posted
- 2026-05-07
- Last updated
- 2026-07-08
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival (PFS) (Standard risk cohort) | From randomization to progression or death without documented progression, assessed up to 15 years | The analysis will be performed using the repeated confidence intervals methodology. Two-sided repeated confidence interval will be constructed using the partial likelihood estimate from stratified Cox proportional hazards model and the critical value based on the Lan-DeMets error-spending function that corresponds to the truncated O'Brien-Fleming boundaries. Sensitivity analysis will be performed to assess the possible impact of treatment non-compliance. The actual treatment received may be considered in a multivariable Cox model where possible effects of clinical and biological characteristics on outcome are assessed. |
| Primary | PFS (High-risk cohort) | From randomization to progression or death without documented progression, assessed up to 15 years | Stratified log-rank test will be used for the primary analysis to compare the PFS between arms D and C. |
| Secondary | Overall survival (OS) (Standard risk cohort) | From randomization to death due to any cause, assessed up to 15 years | The analysis will be performed using the stratified log-rank test. To preserve the overall type I error rate, critical values at the interim efficacy analyses will be determined using a truncated version of the Lan-DeMets error spending function corresponding to the O'Brien-Fleming boundary. |
| Secondary | OS (High risk cohort) | From randomization to death due to any cause, assessed up to 15 years | Stratified log-rank test will be used to compare the OS between the two arms. |
| Secondary | Incidence of adverse events | Up to 30 days after last dose of study treatment | Will be measured using the most recent version of the Common Terminology Criteria for Adverse Events. |
| Other | Estimates of treatment effects by sex | Up to 15 years | Estimates of the primary outcome treatment effect and the corresponding 95% confidence intervals (CIs) by sex. |
| Other | Estimates of treatment effects by race | Up to 15 years | Estimates of the primary outcome treatment effect and the corresponding 95% CIs by race. |
| Other | Estimates of treatment effects by ethnicity | Up to 15 years | Estimates of the primary outcome treatment effect and the corresponding 95% CIs by ethnicity. |
Source ClinicalTrials.gov
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180820 | ECOG-ACRIN Network Group Operations Center | ODwyer, Peter J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
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/NCT07572123
GET https://conductscience.org/api/trials/v1/NCT07572123/registered