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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
NCT05041309
Ethics application status
Date submitted
27/08/2021
Date registered
13/09/2021

Titles & IDs
Public title
Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
Scientific title
Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
Secondary ID [1] 0 0
2020-005843-21
Secondary ID [2] 0 0
KT-US-982-5968
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid and Hematological Malignancies 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Axicabtagene Ciloleucel
Treatment: Other - Brexucabtagene Autoleucel
Treatment: Other - KITE-585
Treatment: Other - KITE-718
Treatment: Other - KITE-439
Treatment: Other - KITE-222
Treatment: Other - KITE-363

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

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

Experimental: KITE-585 - All participants who previously received KITE-585 in the parent study will be enrolled in this arm for long-term follow-up.

Experimental: KITE-718 - All participants who previously received KITE-718 in the parent study will be enrolled in this arm for long-term follow-up.

Experimental: KITE-439 - All participants who previously received KITE-439 in the parent study will be enrolled in this arm for long-term follow-up.

Experimental: KITE-222 - All participants who previously received KITE-222 in the parent study will be enrolled in this arm for long-term follow-up.

Experimental: KITE-363 - All participants who previously received KITE-363 in the parent study will be enrolled in this arm 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: KITE-585
No investigational product will be administered

Treatment: Other: KITE-718
No investigational product will be administered

Treatment: Other: KITE-439
No investigational product will be administered

Treatment: Other: KITE-222
No investigational product will be administered

Treatment: Other: KITE-363
No investigational product will be administered
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
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
Vector Integration Site(s) for Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL) or Insertional Mutagenesis for Confirmed Events Related to the Cell Therapy Product
Timepoint [3] 0 0
Up to 15 years
Primary outcome [4] 0 0
Height of Pediatric and Adolescent Participants
Timepoint [4] 0 0
Up to 15 years
Primary outcome [5] 0 0
Weight of Pediatric and Adolescent Participants
Timepoint [5] 0 0
Up to 15 years
Primary outcome [6] 0 0
Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale
Timepoint [6] 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
Cause of Death
Timepoint [3] 0 0
Up to 15 years
Secondary outcome [4] 0 0
Peripheral B-cell and Lymphocytes Levels for Immune Reconstitution
Timepoint [4] 0 0
Up to 15 years
Secondary outcome [5] 0 0
Rate of Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL)
Timepoint [5] 0 0
Up to 15 years

Eligibility
Key inclusion criteria
* The individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued 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
Can healthy volunteers participate?
No
Key exclusion criteria
none

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
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
700
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
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
Canada
State/province [21] 0 0
Montreal
Country [22] 0 0
Canada
State/province [22] 0 0
Ottawa
Country [23] 0 0
Canada
State/province [23] 0 0
Toronto
Country [24] 0 0
Canada
State/province [24] 0 0
Vancouver
Country [25] 0 0
France
State/province [25] 0 0
Lille
Country [26] 0 0
France
State/province [26] 0 0
Paris
Country [27] 0 0
France
State/province [27] 0 0
Pessac
Country [28] 0 0
France
State/province [28] 0 0
Pierre Benite
Country [29] 0 0
France
State/province [29] 0 0
Rennes
Country [30] 0 0
Germany
State/province [30] 0 0
Dresden
Country [31] 0 0
Germany
State/province [31] 0 0
Heidelberg
Country [32] 0 0
Germany
State/province [32] 0 0
München
Country [33] 0 0
Germany
State/province [33] 0 0
Wuerzburg
Country [34] 0 0
Israel
State/province [34] 0 0
Tel Aviv
Country [35] 0 0
Japan
State/province [35] 0 0
Fukuoka
Country [36] 0 0
Japan
State/province [36] 0 0
Kyoto
Country [37] 0 0
Japan
State/province [37] 0 0
Okayama
Country [38] 0 0
Japan
State/province [38] 0 0
Sapporo Hokkaido
Country [39] 0 0
Japan
State/province [39] 0 0
Tokyo
Country [40] 0 0
Netherlands
State/province [40] 0 0
Amsterdam
Country [41] 0 0
Netherlands
State/province [41] 0 0
Groningen
Country [42] 0 0
Netherlands
State/province [42] 0 0
Nijmegen
Country [43] 0 0
Netherlands
State/province [43] 0 0
Rotterdam
Country [44] 0 0
Netherlands
State/province [44] 0 0
Utrecht
Country [45] 0 0
United Kingdom
State/province [45] 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