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NCT04491370 · ClinicalTrials.gov registry record · Phase 1
Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma
A Phase 1 study, sponsored by New York Medical College.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT04491370: Recruiting Phase 1 study, sponsored by New York Medical College.
NCT04491370 is a Phase 1 study that is actively recruiting participants, run by New York Medical College. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04491370, a Phase 1 study, is actively recruiting participants, sponsored by New York Medical College.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Patients will receive one of two conditioning regimens (BEAM or CBV) before receiving an autologous stem cell transplant (ASCT). If patients achieve either complete, partial, or stable response following ASCT, they will receive an IV dose of Polatuzumab Vedotin once every 21 days until they receive 8 doses. After Polatuzumab Vedotin therapy is completed, patients will be followed every 4 months for about 2 years.
Primary Outcome
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 n
Interventions
- DRUG Polatuzumab vedotin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-08-01 |
| Est. Completion | 2027-08-15 |
| Phase | Phase 1 |
What NCT04491370 shows while recruiting
NCT04491370 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Polatuzumab vedotin is the first listed.
NCT04491370 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04491370 about?
NCT04491370 is a clinical study titled "Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma". Patients will receive one of two conditioning regimens (BEAM or CBV) before receiving an autologous stem cell transplant (ASCT). If patients achieve either complete, partial, or stable response following ASCT, they will receive an IV dose of Polatuzumab Vedotin once every 21 days until they receive ...
What is the current status of trial NCT04491370?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2021-08-01. Estimated completion is 2027-08-15.
What interventions are being tested in trial NCT04491370?
The interventions under investigation include: Polatuzumab vedotin (DRUG).
Who is sponsoring clinical trial NCT04491370?
This trial is sponsored by New York Medical College, which has 47 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04491370's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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