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

NCT06482684 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-07-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

KTE-X19

See description of treatment arms

DRUG

Ibrutinib

See description of treatment arms

Sponsors & Collaborators

  • Johannes Gutenberg University Mainz

    collaborator OTHER

  • Christian Schmidt, MD

    lead OTHER

Principal Investigators

  • Georg Hess, MD · Johannes Gutenberg University Mainz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-15
Primary Completion
2031-06-15
Completion
2031-12-31
FDA Drug
Yes

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06482684 on ClinicalTrials.gov