RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-01-08

Study Completion:2028-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06043323

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Men and women 18 years of age or older * Histologically proven FL (Grade 1-3A) * Relapsed or refractory following 2 or more prior lines of systemic therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Medically appropriate for CAR-T cell therapy: adequate organ function CrCL \>/= 45 mL/min/m2, hemoglobin level ≥ 8 g/dl, serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 x ULN if documented liver involvement, baseline oxygen saturation levels (SpO2) ≥92% on room air * Have at least 2 measurable lesions on imaging, defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) and ≥1 cm on CT, MRI, or clinical exam. At least one lesion will be omitted from the radiation treatment field. * Prior radiation therapy is permitted provided normal tissue tolerance is not exceeded * Female of child-bearing potential (FOCBP, defined below) must have a negative pregnancy test within 1 week of simulation for RT * Ability to understand and the willingness to sign a written informed consent document.	* Histologic evidence of transformed follicular lymphoma, or follicular lymphoma grade 3B * History of invasive malignancy requiring active therapy (systemic therapy, radiation, or surgery) within the past 3 years, excluding non-melanomatous skin cancer * Women of childbearing potential who are pregnant * Women who are breastfeeding and unwilling to discontinue prior to lymphodepleting chemotherapy and for 12 months following lymphodepleting chemotherapy and CAR-T cell infusion * Urgent need for bridging chemotherapy or rituximab between apheresis and CAR T cell product infusion (steroids permitted) * Additional RT would exceed standard organ at risk constraints * History of severe, immediate hypersensitivity reaction attributed to aminoglycosides * Uncontrolled fungal, bacterial, or viral infection requiring intravenous antimicrobials for management. Urinary tract infection and uncomplicated bacterial pharyngitis is permitted if responding to active treatment. Recent COVID19 infection is permitted if patient is deemed medically stable for CAR-T cell therapy.

Inclusion Criteria

Exclusion Criteria

* Men and women 18 years of age or older
* Histologically proven FL (Grade 1-3A)
* Relapsed or refractory following 2 or more prior lines of systemic therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Medically appropriate for CAR-T cell therapy: adequate organ function CrCL \>/= 45 mL/min/m2, hemoglobin level ≥ 8 g/dl, serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 x ULN if documented liver involvement, baseline oxygen saturation levels (SpO2) ≥92% on room air
* Have at least 2 measurable lesions on imaging, defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) and ≥1 cm on CT, MRI, or clinical exam. At least one lesion will be omitted from the radiation treatment field.
* Prior radiation therapy is permitted provided normal tissue tolerance is not exceeded
* Female of child-bearing potential (FOCBP, defined below) must have a negative pregnancy test within 1 week of simulation for RT
* Ability to understand and the willingness to sign a written informed consent document.

* Histologic evidence of transformed follicular lymphoma, or follicular lymphoma grade 3B
* History of invasive malignancy requiring active therapy (systemic therapy, radiation, or surgery) within the past 3 years, excluding non-melanomatous skin cancer
* Women of childbearing potential who are pregnant
* Women who are breastfeeding and unwilling to discontinue prior to lymphodepleting chemotherapy and for 12 months following lymphodepleting chemotherapy and CAR-T cell infusion
* Urgent need for bridging chemotherapy or rituximab between apheresis and CAR T cell product infusion (steroids permitted)
* Additional RT would exceed standard organ at risk constraints
* History of severe, immediate hypersensitivity reaction attributed to aminoglycosides
* Uncontrolled fungal, bacterial, or viral infection requiring intravenous antimicrobials for management. Urinary tract infection and uncomplicated bacterial pharyngitis is permitted if responding to active treatment. Recent COVID19 infection is permitted if patient is deemed medically stable for CAR-T cell therapy.

Contacts and Locations

Study Contact

Susan Wu, MD

CONTACT

(281) 630-7607

sywu1@mdanderson.org

Principal Investigator

Susan Wu, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Susan Wu, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-08

Study Completion Date2028-09-01

Study Record Updates

Study Start Date2024-01-08

Study Completion Date2028-09-01

Terms related to this study

Additional Relevant MeSH Terms

Follicular Lymphoma