Phase 2 Trial of Lisocabtagene Maraleucel for Minimal Residual Disease in Patients With Large B-cell Lymphoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

R-CHOP (cyclophosphamide, doxorubicin, vincristine sulfate, and prednisone)

DA-EPOCH-R

Polatuzumab-R-CHP 8. Achieved complete metabolic response by Lugano criteria4 at the end of treatment response evaluation after first line treatment

Absolute neutrophil count (ANC) ≥1.0 × 109 /L*

Disqualifiers

Having radiologically confirmed relapsed/refractory disease.

Have not recovered from non-hematological AEs due to prior first line therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.

Known central nervous system lymphoma or leptomeningeal disease.

Adequately treated localized non-melanoma skin cancer without evidence of disease.

Trial design

Treatments tested in this trial

  • Leukapheresis
  • Lymphodepleting Chemotherapy

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators