Phase 2 Trial of Lisocabtagene Maraleucel for Minimal Residual Disease in Patients With Large B-cell Lymphoma
M.D. Anderson Cancer Center
Summary
The goal of the main clinical research study is to learn if treatment with a chimeric antigen receptor (CAR) T-cell therapy called lisocabtagene maraleucel (liso-cel) can help to prevent recurrence of large B-cell cell lymphoma in patients who have achieved complete response (CR) after standard first-line therapy but have tested positive for lymphoma DNA. CAR T therapy is a type of treatment that uses your own immune cells to fight your cancer. The safety of this treatment will also be studied.
Description
Primary Objective: To determine the event-free survival (EFS) of following treatment with lisocabtagene maraleucel in patients with LBCL who have detectable MRD by Foresight CLARITY™ at the end of standard first line treatment Secondary Objectives: To determine the rate of undetectable MRD, progression-free survival (PFS), overall survival (OS), and evaluate safety of lisocabtagene maraleucel as treatment for patients with LBCL who have detectable MRD by Foresight CLARITY™ at end of standard first line treatment To evaluate safety of lisocabtagene maraleucel as treatment for patients with…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Patients must meet the following criteria for study entry: 2\. Age ≥18 years 3. Histologically diagnosed 4. Diffuse large B-cell lymphoma, not otherwise specified (NOS) or 5. High grade B-cell lymphoma (NOS or MYC and BCL2 rearrangements) 6. International Prognostic Index score ≥ 3 or 1-2 with LDH \> 1.3 x ULN and/or bulky disease (single lesion of ≥ 7cm) 7. Received first line standard of care anthracycline-based chemoimmunotherapy for 6 cycles (with or without 2 more cycles of rituximab) for previously untreated disease * R-CHOP (cyclophosphamide, doxorubicin, vincrist…
Interventions
- ProcedureLeukapheresis
Given by infusion
- DrugLymphodepleting Chemotherapy
Given by IV
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas