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

JRCT ID: jRCT2063230096

Registered date:31/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Relapsed/refractory follicular lymphoma
• Date of first enrollment: 01/02/2024
• Target sample size: 230
• Countries of recruitment: United States,Japan,United Kingdom,Japan,France,Japan,Germany,Japan,Italy,Japan,Spain,Japan
• Study type: Interventional

Intervention(s)

Subjects in the axicabtagene ciloleucel treatment arm will receive a single infusion of axicabtagene ciloleucel.
Subjects in the SOCT arm will receive the investigators choice of either rituximab plus lenalidomide (R2), rituximab plus CHOP, or rituximab plus bendamustine.

Outcome(s)

• Primary Outcome: Progression-free Survival (PFS) as Assessed by Blinded Central Assessment per Lugano Classification

Secondary Outcome

- Overall survival (OS)
- Complete response (CR) rate per Lugano Classification {Cheson 2014} as determined per a blinded central assessment
- Objective response rate (CR + partial response per Lugano Classification {Cheson 2014}) as determined per a blinded central assessment
- Duration of response
- Duration of CR
- Event free survival
- Time to next treatment
- Incidence of adverse events (AEs) and clinically significant changes in safety laboratory values
- Incidence of replication competent retrovirus (RCR) detection in blood over time
- Change from baseline in the Global Health Status Quality of Life scale and the physical functioning domain of the European Organisation for Research and Treatment of
Cancer-30 and Low Grade Non-Hodgkin Lymphoma-20
- Change from baseline in the EuroQoL 5-Dimension 5-Level index and visual analogue scale

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Histologically-confirmed follicular lymphoma (FL) (Grade 1, 2, or 3a)
2. Relapsed/refractory 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
3. Clinical indication for treatment.
4. At least 1 measurable lesion per the Lugano Classification {Cheson 2014}
5. Adequate renal, hepatic, pulmonary, and cardiac function

Exclude 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 Grade 1 or 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.

Related Information

• Primary Sponsor: Asou Hiroya
• Secondary ID(s): NCT05371093,2021-003260-28