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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Leukapheresis

    Procedure/Surgery

    Given by infusion

  • Lymphodepleting Chemotherapy

    Drug

    Given by IV

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Liso-cel in patients with LBCLExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety and Adverse Events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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