Trial · NCT03517137
Very Early PET-response Adapted Targeted Therapy for Advanced Hodgkin Lymphoma: a Single -Arm Phase II Study
NCT03517137, Phase 2, Active not recruiting, European Organisation for Research and Treatment of Cancer - EORTC; results first posted 2025-08-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Very Early PET-response Adapted Targeted Therapy for Advanced Hodgkin Lymphoma: a Single -Arm Phase II Study. Trials, record NCT03517137. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03517137
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Very Early PET-response Adapted Targeted Therapy for Advanced Hodgkin Lymphoma: a Single -Arm Phase II Study
- NCT number
- NCT03517137
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 150 participants, actual
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
- Conditions
- Advanced Hodgkin Lymphoma
- Interventions
- Brentuximab Vedotin, Adriamycin, Vinblastine, Dacarbazine, Etoposide, Cyclophosphamide, Radiation Therapy
- First posted
- 2018-05-07
- Last updated
- 2026-09-11
- Results first posted
- 2025-08-11
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Modified Progression-free Survival (mPFS) Rate at 2 Years | 2 years from the date of treatment start | Modified PFS (mPFS) is defined as the time interval between the date of treatment start and the date of the first of: * Progressive disease (PD) * Start of new treatment for Classical Hodgkin Lymphoma (cHL) when not in Complete Response at the end of protocol treatment; in this case, the date of mPFS is the date of the FDG-PET/CT scan at the end of protocol treatment. Switching therapy prior to end of protocol treatment for reasons other than Progressive Disease is not considered an event for mPFS. "End of protocol treatment" refers to completion of the planned protocol treatment with no more than 1 missed cycle, including radiotherapy on PET positive lesions if administered * Death due to any cause |
| Secondary | Proportion of Patients With a Negative FDG-PET | At day 22 to 23 from start of treatment (day 1 = date of start of treatment) | It will be assessed how many patients have a negative FDG-PET image when taken at the end of their first cycle of BrAVD. The BrAVD cycle lasts 4 weeks. |
| Secondary | Progression-free Survival (PFS) Rate at 2 Years | 2 years from the date of treatment start | Progression-free survival |
| Secondary | Overall Survival Rate at 2 Years | 2 years from the date of treatment start | Overall survival |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Modified Progression-free Survival (mPFS) Rate at 2 Years | 2 years from the date of treatment start | All registered and eligible patients, who started the allocated treatment according to the result of the FDG-PET/CT after 1 cycle of BrAVD, as assessed by central review. | Percent probability | NUMBER |
| SECONDARY | Proportion of Patients With a Negative FDG-PET | At day 22 to 23 from start of treatment (day 1 = date of start of treatment) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival (PFS) Rate at 2 Years | 2 years from the date of treatment start | Percent probability | NUMBER | |
| SECONDARY | Overall Survival Rate at 2 Years | 2 years from the date of treatment start | Percent probability | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Modified Progression-free Survival (mPFS) Rate at 2 Years | Evaluable Population | 89.5 | 80% Confidence Interval 85.7 to 92.4 | Percent probability | |
| Proportion of Patients With a Negative FDG-PET | Treatment | Negative | 90 | Participants | |
| Proportion of Patients With a Negative FDG-PET | Treatment | Positive | 60 | Participants | |
| Progression-free Survival (PFS) Rate at 2 Years | Evaluable Population | 89.5 | 95% Confidence Interval 83.3 to 93.6 | Percent probability | |
| Overall Survival Rate at 2 Years | Evaluable Population | 100 | Percent probability |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment | 150 | |
| Overall Study | COMPLETED | Treatment | 141 | |
| Overall Study | NOT COMPLETED | Treatment | 9 |
Source ClinicalTrials.gov
Adverse events304
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANEMIA | Blood and lymphatic system disorders | Treatment | 40 | 150 | 147 |
| other | FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | Treatment | 14 | 150 | 23 |
| other | LYMPH NODE PAIN | Blood and lymphatic system disorders | Treatment | 3 | 150 | 4 |
| other | CHEST PAIN - CARDIAC | Cardiac disorders | Treatment | 1 | 150 | 1 |
| other | PERICARDIAL EFFUSION | Cardiac disorders | Treatment | 2 | 150 | 3 |
| other | SINUS TACHYCARDIA | Cardiac disorders | Treatment | 7 | 150 | 7 |
| other | EAR PAIN | Ear and labyrinth disorders | Treatment | 1 | 150 | 1 |
| other | HEARING IMPAIRED | Ear and labyrinth disorders | Treatment | 1 | 150 | 1 |
| other | MIDDLE EAR INFLAMMATION | Ear and labyrinth disorders | Treatment | 1 | 150 | 1 |
| other | TINNITUS | Ear and labyrinth disorders | Treatment | 4 | 150 | 4 |
1 to 10 of 304Source ClinicalTrials.gov
See all 304 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment | 0 | 150 |
| Total, other adverse events | Treatment | 149 | 150 |
| Total, serious adverse events | Treatment | 45 | 150 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT03517137
GET https://conductscience.org/api/trials/v1/NCT03517137/events?page=2