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Study to Evaluate the Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in People With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

NCT03624036 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-11-18

Study results available
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Summary

The primary objective of this study is to evaluate the safety and tolerability of brexucabtagene autoleucel (KTE-X19) in adults with relapsed/refractory chronic lymphocytic leukemia (r/r CLL) and small lymphocytic lymphoma (r/r SLL) who have received at least 2 prior lines of treatment, one of which must include a Bruton's tyrosine kinase (BTK) inhibitor.

After the end of KTE-C19-108, participants who received an infusion of brexucabtagene autoleucel will complete the remainder of the 15-year follow-up assessments in a separate Long-term Follow-up study, KT-US-982-5968 (NCT05041309).

Conditions

  • Relapsed/Refractory Chronic Lymphocytic Leukemia and Relapsed/Refractory Small Lymphocytic Lymphoma

Interventions

BIOLOGICAL

brexucabtagene autoleucel

CAR-transduced autologous T cells administered intravenously

DRUG

Fludarabine

Administered intravenously

DRUG

Cyclophosphamide

Administered intravenously

Sponsors & Collaborators

  • Kite, A Gilead Company

    lead INDUSTRY

Principal Investigators

  • Kite Study Director · Kite, A Gilead Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-15
Primary Completion
2021-02-12
Completion
2022-11-18
FDA Drug
Yes

Countries

  • United States
  • Italy

Study Locations

More Related Trials

Entities

Drugs

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 NCT03624036 on ClinicalTrials.gov