Purpose

The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in combination with either rituximab or lenalidomide, as measured by assessment of response rates in adult participants with relapsed/refractory large B-cell lymphoma.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histologically confirmed large B-cell lymphoma
  • Chemotherapy-refractory disease, defined as one or more of the following:
  • No response to first-line therapy (primary refractory disease)
  • No response to second or greater lines of therapy OR
  • Refractory after autologous stem cell transplant (ASCT)
  • At least 1 measureable lesion according to the Lugano Classification (Cheson 2014).
  • Individuals must have received adequate prior therapy, including at a minimum:
  • Anti-CD20 monoclonal antibody
  • An anthracycline-containing chemotherapy regimen
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate renal, hepatic, pulmonary, and cardiac function
  • Individuals must be able to comply with relevant, equivalent requirements adopted from the REVLIMID Risk Evaluation and Mitigation Strategy (REMS)® (United States) or additional Risk Minimization Measures (aRMMs) as part of the Risk Management Plan (RMP) (European Union)

Exclusion Criteria

  • Known CD19 negative or CD20 negative tumor
  • History of Richter's transformation of Chronic Lymphocytic Leukemia (CLL)
  • Prior lenalidomide or other immunomodulatory imide drug (IMiD) treatment
  • Prior CAR therapy or other genetically modified T-cell therapy
  • Prior organ transplantation including prior allogeneic stem cell transplant (SCT)
  • Prior CD19 targeted therapy
  • Clinically significant infection or cardiopulmonary disease
  • Presence of any in-dwelling lines or drains (dedicated central venous access catheters allowed)
  • History or presence of central nervous system (CNS) lymphoma or nonmalignant CNS disorder or cerebrospinal fluid (CSF) malignant cells or brain metastases
  • History of autoimmune disease
  • History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last year

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Axicabtagene Ciloleucel and Rituximab Combination
Participants will receive rituximab, and fludarabine and cyclophosphamide conditioning chemotherapy, followed by axicabtagene ciloleucel and additional rituximab.
  • Biological: Axicabtagene Ciloleucel
    A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously
    Other names:
    • Yescarta®
  • Drug: Rituximab
    Administered intravenously
    Other names:
    • RITUXAN®
  • Drug: Fludarabine
    Administered according to package insert
  • Drug: Cyclophosphamide
    Administered according to package insert
Experimental
Axicabtagene Ciloleucel and Lenalidomide Combination
Participants will receive lenalidomide, and fludarabine and cyclophosphamide conditioning chemotherapy, followed by axicabtagene ciloleucel and additional lenalidomide.
  • Biological: Axicabtagene Ciloleucel
    A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously
    Other names:
    • Yescarta®
  • Drug: Lenalidomide
    Capsule(s) administered orally with or without food
    Other names:
    • REVLIMID®
  • Drug: Fludarabine
    Administered according to package insert
  • Drug: Cyclophosphamide
    Administered according to package insert

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232

More Details

Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

Medical Information
1-844-454-5483(1-844-454-KITE)
medinfo@kitepharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.