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NCT04665765 · ClinicalTrials.gov registry record · Phase 2
Polatuzumab Vedotin, Rituximab, Ifosfamide, Carboplatin, and Etoposide (PolaR-ICE) as Initial Salvage Therapy for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
A Phase 2 study of Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
- 2
- Study locations
NCT04665765: Active Phase 2 study of Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, sponsored by City of Hope Medical Center.
NCT04665765 is a Phase 2 study of Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 41 participants, below the 47-participant average among 43 other Recurrent Diffuse Large B-Cell Lymphoma trials with a reported enrollment target (13% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04665765, a Phase 2 study of Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial studies the effect of polatuzumab vedotin, rituximab, ifosfamide, carboplatin, and etoposide as initial salvage therapy in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin. Polatuzumab attaches to CD79b positive cancer cells in a targeted way and delivers vedotin to kill them. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with immunotherapy may kill more cancer cells in patients with diffuse large B-cell lymphoma.
Primary Outcome
Estimated by the proportion of response-evaluable patients achieving CR after 2 cycles of salvage therapy, along with the 95% exact binomial confidence interval. Polatuzumab vedotin (Pola) was added to rituximab, ifosfamide, carboplatin, and etoposide (PolaR-ICE) as salvage therapy.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Etoposide
- BIOLOGICAL Rituximab
- DRUG Ifosfamide
- DRUG Polatuzumab Vedotin
Study Locations (2)
California
- City of Hope Medical Center - Duarte
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2021-01-18 |
| Est. Completion | 2026-07-01 |
| Phase | Phase 2 |
What the registry record for NCT04665765 still lists
NCT04665765 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 47-participant average among 43 other Recurrent Diffuse Large B-Cell Lymphoma trials with a reported enrollment target (13% lower).
The record links to 7 conditions, with Recurrent Diffuse Large B-Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT04665765 reports a single indexed study location in California, Georgia.
Frequently Asked Questions
What is clinical trial NCT04665765 about?
NCT04665765 is a clinical study titled "Polatuzumab Vedotin, Rituximab, Ifosfamide, Carboplatin, and Etoposide (PolaR-ICE) as Initial Salvage Therapy for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma". This phase II trial studies the effect of polatuzumab vedotin, rituximab, ifosfamide, carboplatin, and etoposide as initial salvage therapy in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Polatuzumab vedotin is a mo...
What is the current status of trial NCT04665765?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2021-01-18. Estimated completion is 2026-07-01.
What conditions does trial NCT04665765 study?
This clinical trial studies the following conditions: Recurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Recurrent Transformed B-Cell Non-Hodgkin Lymphoma, Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma, Refractory Transformed B-cell Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT04665765?
The interventions under investigation include: Carboplatin (DRUG), Etoposide (DRUG), Rituximab (BIOLOGICAL), Ifosfamide (DRUG), Polatuzumab Vedotin (DRUG).
Who is sponsoring clinical trial NCT04665765?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04665765 being conducted?
This trial has 2 study locations across California, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04665765's enrollment target sits among peer trials
41 12th of 43 higher than 32 of 43 other Recurrent Diffuse Large B-Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Diffuse Large B-Cell Lymphoma 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.
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