Advancing Regenerative Medicine
Stanford's Alpha Clinic supports the advancement of regenerative therapies in the following ways
Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma
The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- biological: Axicabtagene Ciloleucel
- drug: Cyclophosphamide
- drug: Fludarabine
- drug: Lenalidomide
- drug: Rituximab
- drug: Doxorubicin
- drug: Vincristine
- drug: Prednisone
- drug: Bendamustine
Eligibility
Key Inclusion Criteria:
* Histologically-confirmed follicular lymphoma (FL) (Grade 1, 2, or 3a)
* Relapsed/refractory (R/r) disease after first-line chemoimmunotherapy and high-risk disease with relapse or progression within 24 months of the initial course of chemoimmunotherapy (ie, POD24), Or r/r disease after ≥ 2 prior systemic lines of therapy
* Clinical indication for treatment.
* At least 1 measurable lesion per the Lugano Classification {Cheson 2014}
* Adequate renal, hepatic, pulmonary, and cardiac function
Key Exclusion Criteria:
* Presence of large B cell lymphoma or transformed FL
* Small lymphocytic lymphoma
* Lymphoplasmacytic lymphoma
* Full-thickness involvement of the gastric wall by lymphoma
* FL Grade 3b
* Prior CD19-targeted therapy
* Prior CAR therapy or other genetically modified T-cell therapy
* Uncontrolled fungal, bacterial, viral, or other infection
* Active Infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus
* History or presence of a clincially significant central nervous system (CNS) disorder.
* History of autoimmune disease
* Known history or CNS lymphoma involvement
* Cardiac lymphoma involvement
* History of clinically significant cardiac disease 6 months before randomization
* Neuropathy greater than grade 2
* Females who are pregnant or breastfeeding
* Individuals of both genders who are not willing to practice birth control
* Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, G/J-tube, pleural/peritoneal/pericardial catheter, or Ommaya reservoirs). Dedicated central venous access catheters such as Port-a-Cath or Hickman catheter are permitted.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
ALL
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Christina Tran
ctran13@stanford.edu
I'm interested
The Alpha Clinic Network
We are part of a state-wide network funded by the California Institute for Regenerative Medicine
This network includes: