Study of Axicabtagene Ciloleucel Given With Steroids In Participants With Relapsed Or Refractory Large B-Cell Lymphoma
Purpose
The goal of this clinical study is to learn more about the study drug, axicabtagene ciloleucel, in participants with relapsed or refractory large B-cell lymphoma (LBCL) in the outpatient setting.
Condition
- Relapsed or Refractory Large B-cell Lymphoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Histologically confirmed large B-cell lymphoma (LBCL), including the following types defined by World Health Organization (WHO) 2016 classification, by local pathology laboratory assessment, are eligible as defined below: - Diffuse large B-cell lymphoma (DLBCL) not otherwise specified. - High-grade B-cell lymphoma (HGBL) with or without MYC and BCL2 and/or BCL6 rearrangement. - DLBCL associated with chronic inflammation; Epstein-Barr virus (EBV) + DLBCL. - Primary mediastinal (thymic) LBCL. - Primary cutaneous DLBCL, leg type. - Transformation of follicular lymphoma to DLBCL will also be included. - Relapsed or refractory disease after 1 or more lines of therapy. - Individuals must have received adequate prior therapy including: - Anti-CD20 monoclonal antibody AND - An anthracycline-containing chemotherapy regimen. - At least 1 measurable lesion according to the Lugano Response Criteria for Malignant Lymphoma. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Individual agrees to outpatient treatment setting and to adhere to the prespecified clinical monitoring requirements.
Exclusion Criteria
- History of autologous or allogeneic stem cell transplant. - Prior cluster of differentiation (CD)19 targeted therapy. - Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy. - Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management. Simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite medical monitor. - Individuals with detectable cerebrospinal fluid malignant cells, brain metastases, or with a history of central nervous system (CNS) lymphoma or primary CNS lymphoma. DLBCL epidural involvement should be considered as positive CNS disease. - In the investigator's judgment, the individual is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Axicabtagene Ciloleucel |
Participant will receive lymphodepleting chemotherapy (cyclophosphamide 500 mg/m^2/day and fludarabine 30 mg/m^2/day) over 3 days (Days -5, -4, and -3) followed by prophylactic corticosteroid treatment with 10 mg dexamethasone on Day 0 (prior to axicabtagene ciloleucel), Day 1, and Day 2. Participant will receive axicabtagene ciloleucel consisting of a single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells on Day 0 (following dexamethasone 10 mg) at a target dose of 2 x 10^6 cells/kg. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Kite, A Gilead Company
Study Contact
Detailed Description
Participants who complete at minimum 24 months follow up will be transitioned to a separate long-term follow-up study (study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.