A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06043323
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Axicabtagene Ciloleucel — DRUG
    Given by IV (vein)
  • Cyclophosphamide — DRUG
    Given by IV (vein)
  • Fludarabine phosphate — DRUG
    Given by IV (vein)
  • Prednisone — DRUG
    Given by IV (vein)
  • Diphenhydramine — DRUG
    Given by IV (vein)
  • Acetaminophen — DRUG
    Given by IV (vein)

Study Details

To learn about the safety of a drug called axicabtagene ciloleucel given in combination with radiation therapy to patients with relapsed/refractory FL.

Key Dates

Start date
Jan 8, 2024
Status verified
May 2026
Primary completion
Sep 1, 2026
Completion
Sep 1, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Axicabtagene Ciloleuce
    Participants will first have a procedure to collect your white blood cells that will be used to make axicabtagene ciloleucel. Then participatns will receive radiation therapy, followed by conditioning chemotherapy and 1 infusion of axicabtagene ciloleucel.

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Susan Wu, MD
[email protected]
281-630-7607

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By research site
MD Anderson Cancer Center· Houston, TX

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