A study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in patients with relapsed/refractory Follicular Lymphoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Kite Pharma Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

23 Feb 2023 → ongoing

Decision date (initial)

2024-07-23

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Kite Pharma Inc.

External identifiers

EU CT number

2024-511594-30-00

EudraCT number

2021-003260-28

ClinicalTrials.gov

NCT05371093

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

To determine if axicabtagene ciloleucel is superior to standard of care therapy (SOCT), as measured by progression-free survival (PFS) per a blinded independent radiologic review committee (hereafter referred to as blinded central assessment) in subjects with r/r FL

Secondary objectives 1

1. To further characterize the efficacy and safety profile and patient-reported outcomes associated with axicabtagene ciloleucel versus SOCT

Conditions and MedDRA coding

Relapsed/Refractory Follicular Lymphoma

Regulatory references

Plan to share IPD

No

IPD plan description

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Histologically-confirmed follicular lymphoma (FL) (Grade 1, 2, or 3a)
2. 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
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

Exclusion criteria 18

1. Presence of large B cell lymphoma or transformed FL
2. Small lymphocytic lymphoma
3. Lymphoplasmacytic lymphoma
4. Full-thickness involvement of the gastric wall by lymphoma
5. FL Grade 3b
6. Prior CD19-targeted therapy
7. Prior CAR therapy or other genetically modified T-cell therapy
8. Uncontrolled fungal, bacterial, viral, or other infection
9. Active Infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus
10. History or presence of a clincially significant central nervous system (CNS) disorder.
11. History of autoimmune disease
12. Known history or CNS lymphoma involvement
13. Cardiac lymphoma involvement
14. History of clinically significant cardiac disease 6 months before randomization
15. Neuropathy greater than grade 2
16. Females who are pregnant or breastfeeding
17. Individuals of both genders who are not willing to practice birth control
18. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. PFS, defined as the time from randomization to disease progression per the International Working Group Lugano Classification {Cheson 2014} as determined per a blinded central assessment, or death due to any cause.

Secondary endpoints 11

1. OS
2. CR rate per Lugano Classification {Cheson 2014} as determined per a blinded central assessment
3. ORR (CR + PR per Lugano Classification {Cheson 2014}) as determined per a blinded central assessment
4. DOR
5. Duration of CR
6. EFS
7. TTNT
8. Incidence of adverse events (AEs) and clinically significant changes in safety laboratory values
9. Incidence of replication-competent retrovirus (RCR) detection in blood over time
10. Changes 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 Quality of Life Questionnaire-30 (EORTC QLQ-C30) and the Low Grade NonHodgkin Lymphoma-20 (NHL-LG20)
11. Changes from baseline in the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) and visual analogue scale (VAS).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 7

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Kite Pharma Inc.

Sponsor organisation

Kite Pharma Inc.

Address

2400 Broadway

City

Santa Monica

Postcode

90404-3030

Country

United States

Scientific contact point

Organisation

Kite Pharma Inc.

Contact name

EU CT Support

Public contact point

Organisation

Kite Pharma Inc.

Contact name

EU CT Support

Third parties 5

Locations

4 EU/EEA countries · 27 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 31 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications