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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05495464
Phase
EARLY_PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acalabrutinib — DRUG
    Given by PO
  • Rituximab — DRUG
    Given by IV (vein)
  • Brexucabtagene Autoleucel — OTHER
    Given by IV (vein)
  • Cyclophosphamide — DRUG
    Given by IV (vein)
  • Fludarabine Phosphate — DRUG
    Given by IV (vein)

Study Details

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.

Key Dates

Start date
Nov 18, 2022
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Acalabrutinib and Rituximab (Part 1)
    Participants may receive acalabrutinib and rituximab for up to 12 cycles. Each cycle is 28 days.
  • Experimental: Brexucabtagene Autoleucel (Part 2)
    Participants will have a procedure called leukapheresis to collect enough T cells.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Within 30 days after CAR T-cell infusion ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
M D Anderson Cancer Center· Houston, TX

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