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Axi-cel in CNS Lymphoma

NCT04608487 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-07-30

No results posted yet for this study

Summary

This research is being done to test the safety and effectiveness of axicabtagene ciloleucel (axi-cel), an anti-CD19 directed chimeric antigen receptor (CAR) T-cell therapy in treating relapsed/refractory central nervous system (CNS) lymphoma, systemic lymphoma with concurrent CNS lymphoma, or systemic lymphoma with a history of treated CNS lymphoma, and to better understand what causes neurological toxicity following treatment with axi-cel.

The names of the study drug(s) involved in this study are:

* axicabtagene ciloleucel (axi-cel)
* ludarabine will be given with axicel to help axicel work more effectively
* cyclophosphamide will be given with axicel to help axicel work more effectively

Conditions

Interventions

DRUG

Fludarabine

Intravenous infusion

DRUG

Cyclophosphamide

Intravenous infusion

BIOLOGICAL

Axicabtagene Ciloleucel

Intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • Caron Jacobson, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-04
Primary Completion
2025-06-14
Completion
2038-06-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT04608487 on ClinicalTrials.gov