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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05041309




Registration number
Help: Registration number
NCT05041309
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
27/08/2021
Date registered
Help: Date registered
13/09/2021
Date last updated
Help: Date last updated
21/09/2026

Titles & IDs
Public title
Long-Term Follow-Up Study After Gene-Modified Cell Treatment in Kite Studies
Scientific title
Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
Additional trial identifiers [1] 0 0
2020-005843-21
Additional trial identifiers [2] 0 0
KT-US-982-5968
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Solid and Hematological Malignancies 0 0
Autoimmune Diseases 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of the intervention or exposure
Treatment: Other - Axicabtagene Ciloleucel
Treatment: Other - Brexucabtagene Autoleucel
Treatment: Other - Anitocabtagene autleucel
Treatment: Other - KITE-753
Treatment: Other - KITE-197
Treatment: Other - KITE-363
Treatment: Other - INT2104
Treatment: Other - KITE-512
Treatment: Other - SPRX001
Treatment: Other - SPRX002
Treatment: Other - ARC-T Cells

Axicabtagene Ciloleucel (KTE-C19) - All participants who previously received axicabtagene ciloleucel (KTE-C19) in the parent study will be enrolled in this cohort for long-term follow-up.

Brexucabtagene Autoleucel (KTE-X19) - All participants who previously received brexucabtagene autoleucel (KTE-X19) in the parent study will be enrolled in this cohort for long-term follow-up.

Anitocabtagene autleucel - All participants who previously received anitocabtagene autleucel in the parent study will be enrolled in this cohort for long-term follow-up.

KITE-753 - All participants who previously received KITE-753 in the parent study will be enrolled in this cohort for long-term follow-up.

KITE-197 - All participants who previously received KITE-197 in the parent study will be enrolled in this cohort for long-term follow-up.

KITE-363: Oncology Indication - All participants who previously received KITE-363 for oncology indication in the parent study will be enrolled in this cohort for long-term follow-up.

KITE-363: Autoimmune Indication - All participants who previously received KITE-363 for autoimmune indication in the parent study will be enrolled in this cohort for long-term follow-up.

INT2104 - All participants who previously received INT2104 in the parent study will be enrolled in this cohort for long-term follow-up.

KITE-512 - All participants who previously received KITE-512 in the parent study will be enrolled in this cohort for long-term follow-up.

ACLX-001 (SPRX001 + ARC-T cells) - All participants who previously received ACLX-001 in the parent study will be enrolled in this cohort for long-term follow-up.

ACLX002 (SPRX002 + ARC-T cells) - All participants who previously received ACLX-002 in the parent study will be enrolled in this cohort for long-term follow-up.


Treatment: Other: Axicabtagene Ciloleucel
No investigational product will be administered

Treatment: Other: Brexucabtagene Autoleucel
No investigational product will be administered

Treatment: Other: Anitocabtagene autleucel
No investigational product will be administered

Treatment: Other: KITE-753
No investigational product will be administered

Treatment: Other: KITE-197
No investigational product will be administered

Treatment: Other: KITE-363
No investigational product will be administered

Treatment: Other: INT2104
No investigational product will be administered

Treatment: Other: KITE-512
No investigational product will be administered

Treatment: Other: SPRX001
No investigational product will be administered

Treatment: Other: SPRX002
No investigational product will be administered

Treatment: Other: ARC-T Cells
No investigational product will be administered
Intervention code [1] 0 0
Treatment: Other
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs)
Timepoint [1] 0 0
Up to 15 years
Primary outcome [2] 0 0
Percentage of Participants Experiencing Late-onset Targeted Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to 15 years
Primary outcome [3] 0 0
Percentage of Participants With New Malignancies
Timepoint [3] 0 0
Up to 15 years
Primary outcome [4] 0 0
Percentage of Participants Experiencing Related SAEs
Timepoint [4] 0 0
Up to 15 years
Primary outcome [5] 0 0
Height of Pediatric and Adolescent Participants
Timepoint [5] 0 0
Up to 15 years
Primary outcome [6] 0 0
Weight of Pediatric and Adolescent Participants
Timepoint [6] 0 0
Up to 15 years
Primary outcome [7] 0 0
Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale Score
Timepoint [7] 0 0
Up to 15 years
Secondary outcome [1] 0 0
Time to Subsequent Anticancer Therapies
Timepoint [1] 0 0
Up to 15 years
Secondary outcome [2] 0 0
Survival Status Assessment
Timepoint [2] 0 0
Up to 15 years
Secondary outcome [3] 0 0
Percentage of Participants With Cause of Death
Timepoint [3] 0 0
Up to 15 years
Secondary outcome [4] 0 0
Overall Rate of Replication-competent RCR/RCL
Timepoint [4] 0 0
Up to 15 years
Secondary outcome [5] 0 0
Percentage of Participants With Vector Integration Site(s) for RCR/RCL or Insertional Mutagenesis for Confirmed Events Related to the Cell Therapy Product
Timepoint [5] 0 0
Up to 15 years
Secondary outcome [6] 0 0
Percentage of Participants With Status of Primary Malignant Disease
Timepoint [6] 0 0
Up to 15 years

Eligibility
Key inclusion criteria
* The individual must have been administered gene-modified cell therapy or completed the post-treatment follow-up period in the parent study, as applicable
* The individual must understand and voluntarily sign an Informed Consent Form (ICF) or an Informed Assent Form prior to any study-related assessments or procedures being conducted
* In the investigator's judgment, the individual is willing and able to complete the protocol-required follow-up schedule and comply with the study requirements for participation
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
none

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2040
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
Austria
State/province [25] 0 0
Innsbruck
Country [26] 0 0
Belgium
State/province [26] 0 0
Leuven
Country [27] 0 0
Canada
State/province [27] 0 0
Montreal
Country [28] 0 0
Canada
State/province [28] 0 0
Ottawa
Country [29] 0 0
Canada
State/province [29] 0 0
Québec
Country [30] 0 0
Canada
State/province [30] 0 0
Toronto
Country [31] 0 0
Canada
State/province [31] 0 0
Vancouver
Country [32] 0 0
France
State/province [32] 0 0
Lille
Country [33] 0 0
France
State/province [33] 0 0
Montpellier
Country [34] 0 0
France
State/province [34] 0 0
Paris
Country [35] 0 0
France
State/province [35] 0 0
Pessac
Country [36] 0 0
France
State/province [36] 0 0
Pierre-Bénite
Country [37] 0 0
France
State/province [37] 0 0
Rennes
Country [38] 0 0
Germany
State/province [38] 0 0
Dresden
Country [39] 0 0
Germany
State/province [39] 0 0
Hamburg
Country [40] 0 0
Germany
State/province [40] 0 0
Heidelberg
Country [41] 0 0
Germany
State/province [41] 0 0
Mainz
Country [42] 0 0
Germany
State/province [42] 0 0
München
Country [43] 0 0
Germany
State/province [43] 0 0
Würzburg
Country [44] 0 0
Israel
State/province [44] 0 0
Tel Aviv
Country [45] 0 0
Italy
State/province [45] 0 0
Milan
Country [46] 0 0
Italy
State/province [46] 0 0
Rome
Country [47] 0 0
Japan
State/province [47] 0 0
Fukuoka
Country [48] 0 0
Japan
State/province [48] 0 0
Kyoto
Country [49] 0 0
Japan
State/province [49] 0 0
Okayama
Country [50] 0 0
Japan
State/province [50] 0 0
Sapporo Hokkaido
Country [51] 0 0
Japan
State/province [51] 0 0
Sendai
Country [52] 0 0
Japan
State/province [52] 0 0
Tokyo
Country [53] 0 0
Netherlands
State/province [53] 0 0
Amsterdam
Country [54] 0 0
Netherlands
State/province [54] 0 0
Groningen
Country [55] 0 0
Netherlands
State/province [55] 0 0
Nijmegen
Country [56] 0 0
Netherlands
State/province [56] 0 0
Rotterdam
Country [57] 0 0
Netherlands
State/province [57] 0 0
Utrecht
Country [58] 0 0
Spain
State/province [58] 0 0
Barcelona
Country [59] 0 0
Spain
State/province [59] 0 0
Salamanca
Country [60] 0 0
Switzerland
State/province [60] 0 0
Bellinzona
Country [61] 0 0
United Kingdom
State/province [61] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Kite, A Gilead Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kite Study Director
Address 0 0
Kite, A Gilead Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05041309