Lenzilumab and Axicabtagene Ciloleucel for Large B-Cell Lymphoma (ZUMA-19 Trial)

Phase 1

Waitlist Available

Research Sponsored by Kite, A Gilead Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first infusion date axicabtagene ciloleucel to data cut off date of 09 may 2022 (maximum duration: 22.3 months).

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to treat lymphoma that uses two drugs. The first part is to find out if it's safe and what the best dose is. The second part is to see if it causes any neurological problems.

Eligible Conditions

Large B-Cell Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first infusion date axicabtagene ciloleucel to data cut off date of 09 may 2022 (maximum duration: 22.3 months).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first infusion date axicabtagene ciloleucel to data cut off date of 09 may 2022 (maximum duration: 22.3 months).

This trial's timeline: 3 weeks for screening, Varies for treatment, and first infusion date axicabtagene ciloleucel to data cut off date of 09 may 2022 (maximum duration: 22.3 months). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1: Percentage of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs) Related to Sequenced Therapy With Lenzilumab and Axicabtagene

Secondary study objectives

Phase 1 and Phase 2: Axicabtagene Ciloleucel Pharmacokinetics: Peak Level of Anti-CD19 CAR T Cells in Blood

Phase 1 and Phase 2: Complete Response (CR) Rate Per Internal Working Group (IWG) Lugano Classification as Determined by the Study Investigators

Phase 1 and Phase 2: Duration of Response (DOR) in Participants Who Experience an Objective Response Per IWG Lugano Classification as Determined by Study Investigators

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Lenzilumab and Axicabtagene CiloleucelExperimental Treatment4 Interventions

Phase 1: Participants will receive cyclophosphamide and fludarabine lymphodepleting chemotherapy followed by sequenced therapy of lenzilumab and axicabtagene ciloleucel on Day 0 to determine a recommended Phase 2 dose (RP2D) of lenzilumab. Phase 2: Participants will receive cyclophosphamide and fludarabine lymphodepleting chemotherapy followed by sequenced therapy of lenzilumab, at the RP2D, and axicabtagene ciloleucel on Day 0.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Fludarabine

2012

Completed Phase 4

~1860