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NCT04479267 · ClinicalTrials.gov registry record · Phase 2
Polatuzumab Vedotin and Combination Chemotherapy for the Treatment of Previously Untreated Lymphoma
A Phase 2 study of Diffuse Large B Cell Lymphoma and High Grade B-Cell Lymphoma, sponsored by Barbara Ann Karmanos Cancer Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT04479267: Active Phase 2 study of Diffuse Large B Cell Lymphoma and High Grade B-Cell Lymphoma, sponsored by Barbara Ann Karmanos Cancer Institute.
NCT04479267 is a Phase 2 study of Diffuse Large B Cell Lymphoma and High Grade B-Cell Lymphoma that is active but no longer recruiting, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 8 participants, below the 219-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04479267, a Phase 2 study of Diffuse Large B Cell Lymphoma and High Grade B-Cell Lymphoma, is active but no longer recruiting, sponsored by Barbara Ann Karmanos Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well polatuzumab vedotin and combination chemotherapy work in treating patients with previously untreated double, triple hit lymphoma, Double Expressor Lymphoma or High-Grade B Cell Lymphoma. Polatuzumab vedotin is a monoclonal antibody that works by binding with cancer cells and releasing another chemotherapy drug, called monomethyl auristatin E, into the cell causing the cancer cells to die or stop growing. Chemotherapy drugs, such as rituximab, cyclophosphamide, doxorubicin, and prednisone, 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 polatuzumab vedotin with combination chemotherapy may work better in treating patients with double or triple hit lymphoma compared to combination chemotherapy alone.
Primary Outcome
Will be assessed by modified Lugano response criteria for malignant lymphoma. The complete remission rate will be summarized by a binomial response rate and its associated 2-sided 80% confidence interval (CI) using Pearson-Klopper method. The primary efficacy analysis will be also performed based on all response evaluable subjects as a sensitivity analysis.
Conditions Studied
Interventions
- DRUG Prednisone
- BIOLOGICAL Rituximab
- DRUG Methylprednisolone
- DRUG Prednisolone
- DRUG Polatuzumab Vedotin
Study Locations (1)
Michigan
- Karmanos Cancer Institute - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2020-08-21 |
| Est. Completion | 2026-07-19 |
| Phase | Phase 2 |
What the registry record for NCT04479267 still lists
NCT04479267 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 219-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (96% lower).
The record links to 5 conditions, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Prednisone is the first listed.
NCT04479267 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT04479267 about?
NCT04479267 is a clinical study titled "Polatuzumab Vedotin and Combination Chemotherapy for the Treatment of Previously Untreated Lymphoma". This phase II trial studies how well polatuzumab vedotin and combination chemotherapy work in treating patients with previously untreated double, triple hit lymphoma, Double Expressor Lymphoma or High-Grade B Cell Lymphoma. Polatuzumab vedotin is a monoclonal antibody that works by binding with canc...
What is the current status of trial NCT04479267?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2020-08-21. Estimated completion is 2026-07-19.
What conditions does trial NCT04479267 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma, High Grade B-Cell Lymphoma, Double-Expressor Lymphoma, High Grade B-Cell Lymphoma w/MYC & BCL2 or BCL6 Rearrangements, High Grade B-Cell Lymphoma w/MYC, BCL2 & BCL6 Rearrangements.
What interventions are being tested in trial NCT04479267?
The interventions under investigation include: Prednisone (DRUG), Rituximab (BIOLOGICAL), Methylprednisolone (DRUG), Prednisolone (DRUG), Polatuzumab Vedotin (DRUG).
Who is sponsoring clinical trial NCT04479267?
This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 139 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04479267 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diffuse Large B Cell Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04479267's enrollment target sits among peer trials
8 111th of 114 higher than 4 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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