NCT06482684

CAR-T-cell Treatment for Untreated High Risk MANtle Cell Lymphoma

Early Treatment Intensification in Patients With High Risk Mantle Cell Lymphoma Using CAR-T-cell Treatment After an Abbreviated Induction Therapy With Rituximab and Ibrutinib and 6 Months Ibrutinib Maintenance (Arm A) as Compared to Standard of Care Induction and Maintenance (Arm B)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Christian Schmidt, MD · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

First-line CAR-T-cell consolidation after an abbreviated induction with 2 cycles of Rituximab and Ibrutinib prior to CAR-T-cell treatment and followed by 6 months of maintenance with Ibrutinib in patients with high risk MCL.

Detailed description

This phase II clinical trial will compare the efficacy, safety and tolerability of first-line treatment with KTE-X19 after a shortened induction with Rituximab and Ibrutinib to conventional immunochemotherapy and Ibrutinib followed by ASCT in younger patients in high-risk MCL patients or immunochemotherapy plus BTKi for elderly, but still fit patients (need to be CAR-T-cell eligible). As primarily the potential of CAR-T-cell treatment is evaluated within this trial, in case of failure to achieve a partial response will be treated with 2 additional cycles of R-CHOP, which can be omitted in case of sufficient response to Ibrutinib-based treatment.

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	KTE-X19	See description of treatment arms
DRUG	Ibrutinib	See description of treatment arms

Timeline

• Start date: 2024-02-15
• Primary completion: 2031-06-15
• Completion: 2031-12-31
• First posted: 2024-07-01
• Last updated: 2024-07-01

Locations

2 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study