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Clinical Trials in Germany / NCT05371093
Active, not recruiting Phase 3

Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma

NCT05371093 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2022-09-22
Last updated
2025-10-15

Condition(s) studied

Relapsed/Refractory Follicular Lymphoma

Investigational drug(s) / intervention(s)

Axicabtagene Ciloleucel →Cyclophosphamide →Fludarabine →Lenalidomide →Rituximab →Doxorubicin →Vincristine →Prednisone →Bendamustine →

Axicabtagene Ciloleucel: A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells

Cyclophosphamide: Administered intravenously

Fludarabine: Administered intravenously

Lenalidomide: Administered orally

Rituximab: Administered intravenously

Doxorubicin: Administered intravenously

Vincristine: Administered intravenously

Prednisone: Administered orally

Bendamustine: Administered intravenously

Study summary

The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (52)

FacilityCityRegionStatus
City of Hope (City of Hope National Medical Center, City of Hope Medical Center) Duarte California
Stanford Health Care Stanford California
Moffitt Cancer Center Tampa Florida
The University of Kansas Hospital Westwood Kansas
University of Maryland Greenebaum Comprehensive Cancer Center Baltimore Maryland
Dana-Farber Cancer Institute Boston Massachusetts
Novant Health Cancer Institute Hematology - Charlotte Charlotte North Carolina
Penn State Milton S. Hershey Medical Center Hershey Pennsylvania
TriStar Centennial Medical Center - Cell Processing Nashville Tennessee
Henry-Joyce Cancer Clinic Nashville Tennessee
The University of Texas MD Anderson Cancer Center Houston Texas
Virginia Commonwealth University Richmond Virginia
Hopital Henri Mondor Créteil France
CHU de Dijon Dijon France
Hôpital Claude Huriez-CHU de Lille Lille France
Institut Paoli-Calmettes Marseille France
Hopital Saint Eloi Montpellier France
Hopital Pitie-Salpetriere Paris France
CHU Bordeaux - Hospital Haut-Leveque - Centre Francois Magendie Pessac France
Centre Hospitalier Lyon Sud Pierre-Bénite France
CHU de Poitiers Poitiers France
Hopital Pontchaillou - CHU Rennes Rennes France
Centre Henri Becquerel Rouen France
Universitatsmedizin Gottingen Göttingen Germany
Universitatsklinikum Koln Klinik I fur Innere Medizin Würzburg Germany
ASST Papa Giovanni XXIII Bergamo Italy
Azienda Ospedallero-Universitaria di Bologna Policlinico Sant'Orsola-Malpighi Bologna Italy
Fondazione IRCCS - Istituto Nazionale Tumori Milan Italy
Ospedale San Raffaele Milan Italy
Arcispedale Santa Maria Nuova Reggio Emilia Italy
Istituto Clinico Humanitas-IRCCS Rozzano Italy
Hyogo Medical University Hospital Hyōgo Japan
University Hospital Kyoto Prefectural University of Medicine Kyoto Japan
Tohoku University Hospital Miyagi Japan
Okayama University Hospital Okayama Japan
Osaka University Hospital Osaka Japan
Hospital Universitari Vall d'Hebrón Barcelona Spain
Hospital Clinic de Barcelona Barcelona Spain
Instituto Catalan de Oncologia - Hospital Duran i Reynolds (ICO L'Hospitalet) Barcelona Spain
Hospital General Universitario Gregorio Maranon Madrid Spain

+ 12 more sites — see the full list on the official registry below.

On this site

📄 Yescarta (axicabtagene ciloleucel) drug profile → 📄 Revlimid (lenalidomide) drug profile → 📄 Rituxan (rituximab) drug profile → 📄 Deltasone (prednisone) drug profile →

More Kite, A Gilead Company trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05371093 on ClinicalTrials.gov ↗ ← All trials in Germany