Trial · NCT04491370
Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma
NCT04491370, Phase 1, Phase 2, Recruiting, New York Medical College
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma. Trials, record NCT04491370. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04491370
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma
- NCT number
- NCT04491370
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 20 participants, estimated
- Lead sponsor
- New York Medical College
- Conditions
B-cell Lymphoma, Burkitt Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Transformed Non-Hodgkin Lymphoma, Richter Syndrome, Hodgkin Lymphoma
- Interventions
- Polatuzumab vedotin
- First posted
- 2020-07-29
- Last updated
- 2026-04-15
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerability | 1 year | To evaluate the safety and tolerability of Polatuzumab vedotin (PV) immunoconjugate therapy post myeloablative conditioning (MAC) and autologous stem cell transplantation (AutoSCT) in patients with B-cell non-Hodgkin lymphoma (NHL). Patients receiving 1 dose of Polatuzumab Vedotin will be evaluable for safety. To determine the safety events: Number of participants with treatment-related Grade III or higher adverse events as assessed by CTCAE v5.0. To determine the occurrence of any Grade ≥ 3 non hematologic toxicity (per CTCAE v.5) which is possibly, probably, or definitely related to polatuzumab vedotin. |
| Secondary | EFS, PFS, and OS | 2 years | To measure event free survival (EFS), progression free survival (PFS) and overall survival (OS) in patients with B-cell NHL following MAC and AutoSCT and post AutoSCT PV maintenance therapy. All patients who have completed conditioning and autoSCT will be evaluable for EFS, PFS, and OS. EFS, PFS and OS will utilize Kaplan Meier product limit curve method. Response will be defined for patients with non-Hodgkin's lymphoma who had either measurable or detectable disease at the time of study entry in accordance with the revised IPNHL response criteria (Appendix VI) for patients ≤ 21 years of age and with the Lugano classification (Appendix VII) for patients \> 21 years of age. |
| Secondary | ORR | 2 years | To measure overall response rate (ORR) of PV in B-cell NHL patients who are in PR or SD post MAC AutoSCT. Only in patients who are in PR or SD prior to PV and received a minimum of 3 doses will be evaluable. EFS, PFS and OS will utilize Kaplan Meier product limit curve method. Response will be defined for patients with non-Hodgkin's lymphoma who had either measurable or detectable disease at the time of study entry in accordance with the revised IPNHL response criteria (Appendix VI,\[24\]) for patients ≤ 21 years of age and with the Lugano classification (Appendix VII, \[25\]) for patients \> 21 years of age. |
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.
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/NCT04491370
GET https://conductscience.org/api/trials/v1/NCT04491370/registered