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NCT05934448 · ClinicalTrials.gov registry record · Phase 2
Pembro Plus CAR T-cell Therapy in R/R in PMBCL
A Phase 2 study of Primary Mediastinal Large B Cell Lymphoma and Primary Mediastinal Large B-cell Lymphoma (PMBCL), sponsored by Jennifer Crombie, MD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
- 2
- Study locations
NCT05934448: Recruiting Phase 2 study of Primary Mediastinal Large B Cell Lymphoma and Primary Mediastinal Large B-cell Lymphoma (PMBCL), sponsored by Jennifer Crombie, MD.
NCT05934448 is a Phase 2 study of Primary Mediastinal Large B Cell Lymphoma and Primary Mediastinal Large B-cell Lymphoma (PMBCL) that is actively recruiting participants, run by Jennifer Crombie, MD. The registered enrollment target is 35 participants, below the 58-participant average among 11 other Primary Mediastinal Large B Cell Lymphoma trials with a reported enrollment target (40% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05934448, a Phase 2 study of Primary Mediastinal Large B Cell Lymphoma and Primary Mediastinal Large B-cell Lymphoma (PMBCL), is actively recruiting participants, sponsored by Jennifer Crombie, MD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
- 2
- Study locations
Study Summary
This research study is evaluating the combination of drugs, pembrolizumab with chimeric antigen receptor (CAR) T-cell therapy, as a possible treatment for primary mediastinal B-cell lymphoma that has recurred after prior treatment. The names of the study drugs involved in this study are: \- Pembrolizumab Standard treatment will include: * CAR T-cell therapy (either axicabtagene-ciloleucel or lisocabtagene maraleucel) * Cyclophosphamide * Fludarabine
Primary Outcome
Per Lugano 2014 criteria, Complete Response (CR) is defined as PET-CT, score 1, 2, or 3\* with or without a residual mass on 5 point scale; or on CT, target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, and no extralymphatic sites of disease.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- PROCEDURE Leukapheresis
- DRUG Lymphodepletion Chemotherapy
- DRUG Chimeric Antigen Receptor (CAR) Therapy Infusion
Study Locations (2)
Massachusetts
- Dana-Farber Cancer Institute - Boston
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2023-11-15 |
| Est. Completion | 2031-06-06 |
| Phase | Phase 2 |
What NCT05934448 shows while recruiting
NCT05934448 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 58-participant average among 11 other Primary Mediastinal Large B Cell Lymphoma trials with a reported enrollment target (40% lower).
The record links to 6 conditions, with Primary Mediastinal Large B Cell Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT05934448 reports a single indexed study location in Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT05934448 about?
NCT05934448 is a clinical study titled "Pembro Plus CAR T-cell Therapy in R/R in PMBCL". This research study is evaluating the combination of drugs, pembrolizumab with chimeric antigen receptor (CAR) T-cell therapy, as a possible treatment for primary mediastinal B-cell lymphoma that has recurred after prior treatment. The names of the study drugs involved in this study are: \- Pembro...
What is the current status of trial NCT05934448?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2023-11-15. Estimated completion is 2031-06-06.
What conditions does trial NCT05934448 study?
This clinical trial studies the following conditions: Primary Mediastinal Large B Cell Lymphoma, Primary Mediastinal Large B-cell Lymphoma (PMBCL), T-Cell/Histiocyte-Rich Large B-Cell Lymphoma, Primary Mediastinal Large B-Cell Lymphoma Recurrent, Primary Mediastinal Large B-Cell Lymphoma Refractory.
What interventions are being tested in trial NCT05934448?
The interventions under investigation include: Pembrolizumab (DRUG), Leukapheresis (PROCEDURE), Lymphodepletion Chemotherapy (DRUG), Chimeric Antigen Receptor (CAR) Therapy Infusion (DRUG).
Who is sponsoring clinical trial NCT05934448?
This trial is sponsored by Jennifer Crombie, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05934448 being conducted?
This trial has 2 study locations across Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05934448's enrollment target sits among peer trials
35 7th of 11 higher than 5 of 11 other Primary Mediastinal Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Mediastinal 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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