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A Pilot "Window-3" Study of Acalabrutinib Plus Rituximab Followed by Brexucabtagene Autoleucel Therapy in Patients With Previously Untreated High-risk Mantle Cell Lymphoma

NCT05495464 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-05-20

No results posted yet for this study

Summary

To learn if giving acalabrutinib, rituximab, and brexucabtagene autoleucel to patients with previously untreated high-risk mantle cell lymphoma (MCL) can help to control the disease.

Conditions

Interventions

DRUG

Acalabrutinib

Given by PO

DRUG

Rituximab

Given by IV (vein)

OTHER

Brexucabtagene Autoleucel

Given by IV (vein)

DRUG

Cyclophosphamide

Given by IV (vein)

DRUG

Fludarabine Phosphate

Given by IV (vein)

Sponsors & Collaborators

  • Kite, A Gilead Company

    collaborator INDUSTRY

  • Acerta Pharma, LLC

    collaborator OTHER

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Preetesh Jain, MD, PHD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-18
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05495464 on ClinicalTrials.gov