Blood and marrow transplant clinical trials network — Moffitt Consortium
Blood and Marrow Transplant Clinical Trials Network (BMT CTN) - Core Clinical Centers - UG1
This project compares three different pre‑CAR‑T chemotherapy plans to find which one best helps people with large B‑cell lymphoma receiving approved CD19 CAR‑T treatments.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | H. Lee Moffitt Cancer Ctr & Res Inst NIH-funded |
| Lab location | 1 site (Tampa, United States) |
| Project ID | NIH-11168922 on NIH RePORTER |
What this research studies
If you have large B‑cell lymphoma and are getting CD19 CAR‑T therapy, you could be randomly assigned to one of three lymphodepleting chemotherapy plans before your CAR‑T infusion: standard fludarabine/cyclophosphamide with fludarabine dosing adjusted by a modeling approach, bendamustine, or cladribine/cyclophosphamide. The trial uses two approved commercial CAR‑T products (axi‑cel and liso‑cel) and enrolls patients across multiple transplant centers in the national BMT CTN. Doctors will collect treatment details, track disease status for at least 12 months, and monitor serious side effects closely. The Moffitt Consortium is providing leadership and enrolling patients as part of this multicenter randomized phase II effort.
Who could benefit from this research
Good fit: Adults with relapsed or refractory large B‑cell lymphoma who are planning to receive CD19 CAR‑T therapy with axi‑cel or liso‑cel and who meet the trial's medical and safety criteria are ideal candidates.
Not a fit: People not receiving CD19 CAR‑T (axi‑cel or liso‑cel), those with different cancer types, or individuals too frail or medically ineligible for lymphodepleting chemotherapy would not be expected to benefit from participation.
Why it matters
Potential benefit: If successful, the project could identify a lymphodepletion approach that improves one‑year disease control and/or reduces serious treatment toxicity for CAR‑T recipients with large B‑cell lymphoma.
How similar studies have performed: Single‑center series and observational reports support each regimen, but this is the first large randomized trial to compare these lymphodepletion approaches head‑to‑head.
Where this research is happening
Tampa, United States
- H. Lee Moffitt Cancer Ctr & Res Inst — Tampa, United States (Active)
Researchers
- Principal investigator: Pidala, Joseph a — H. Lee Moffitt Cancer Ctr & Res Inst
- Study coordinator: Pidala, Joseph a
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.