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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02445222




Registration number
NCT02445222
Ethics application status
Date submitted
1/05/2015
Date registered
15/05/2015
Date last updated
25/11/2024

Titles & IDs
Public title
CAR-T Long Term Follow Up (LTFU) Study
Scientific title
Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy
Secondary ID [1] 0 0
2014-001673-14
Secondary ID [2] 0 0
CCTL019A2205B
Universal Trial Number (UTN)
Trial acronym
PAVO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Previously treated CAR-T patients

Other: Previously treated CAR-T patients - Patients who previously were exposed to lentiviral-based CART cell therapy


Treatment: Other: Previously treated CAR-T patients
Lentiviral-based CAR-T cell therapy
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of patients with certain events (see description)
Timepoint [1] 0 0
at M3 post treatment, M6, M9, M12 and then, every 6M up to year 5, yearly until year 15.
Secondary outcome [1] 0 0
Percentage of patients with detectable CAR transgene levels in peripheral blood by q-PCR at pre- specified time points
Timepoint [1] 0 0
at M3 post treatment, M6, M9, M12 and every 6M up to year 5, yearly until year 15.
Secondary outcome [2] 0 0
Percentage of patients with detectable RCL by VSV-G
Timepoint [2] 0 0
at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15
Secondary outcome [3] 0 0
Percentage of patients who relapse or progress among patients who had not relapsed or progressed at study entry/re-entry;Incidence of death
Timepoint [3] 0 0
at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15.
Secondary outcome [4] 0 0
B- and T- lymphocyte count
Timepoint [4] 0 0
at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15.
Secondary outcome [5] 0 0
Height and weight, Tanner staging, menstruation status
Timepoint [5] 0 0
at M3 post treatment then M6, M12 and every year until year 15.

Eligibility
Key inclusion criteria
* All patients who have received a CAR-T therapy and completed or discontinued early from a Novartis sponsored treatment protocol that utilized CAR-T cells or from any CAR-T trial sponsored by the University of Pennsylvania with which Novartis has a contractual agreement to co-develop the CAR technology.
* Patients who have provided informed consent for the long term follow up study prior to their study participation .
Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* There are no specific exclusion criteria for this study.

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
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
Single group
Other design features
Phase
Phase 3
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
5/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/02/2036
Actual
Sample size
Target
1400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Melbourne
Recruitment hospital [2] 0 0
Novartis Investigative Site - Camperdown
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
NSW - Camperdown
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
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
United States of America
State/province [16] 0 0
Wisconsin
Country [17] 0 0
Austria
State/province [17] 0 0
Linz
Country [18] 0 0
Austria
State/province [18] 0 0
Wien
Country [19] 0 0
Belgium
State/province [19] 0 0
Gent
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Denmark
State/province [22] 0 0
Copenhagen
Country [23] 0 0
Finland
State/province [23] 0 0
Helsinki
Country [24] 0 0
France
State/province [24] 0 0
Paris 10
Country [25] 0 0
France
State/province [25] 0 0
Paris
Country [26] 0 0
France
State/province [26] 0 0
Pierre Benite
Country [27] 0 0
Germany
State/province [27] 0 0
Bavaria
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin
Country [29] 0 0
Germany
State/province [29] 0 0
Frankfurt
Country [30] 0 0
Germany
State/province [30] 0 0
Hamburg
Country [31] 0 0
Germany
State/province [31] 0 0
Koeln
Country [32] 0 0
Germany
State/province [32] 0 0
Leipzig
Country [33] 0 0
Germany
State/province [33] 0 0
Muenchen
Country [34] 0 0
Germany
State/province [34] 0 0
Ulm
Country [35] 0 0
Germany
State/province [35] 0 0
Wuerzburg
Country [36] 0 0
Israel
State/province [36] 0 0
Ramat Gan
Country [37] 0 0
Israel
State/province [37] 0 0
Tel Aviv
Country [38] 0 0
Italy
State/province [38] 0 0
MB
Country [39] 0 0
Italy
State/province [39] 0 0
RM
Country [40] 0 0
Japan
State/province [40] 0 0
Fukuoka
Country [41] 0 0
Japan
State/province [41] 0 0
Hokkaido
Country [42] 0 0
Japan
State/province [42] 0 0
Miyagi
Country [43] 0 0
Japan
State/province [43] 0 0
Kyoto
Country [44] 0 0
Netherlands
State/province [44] 0 0
CS
Country [45] 0 0
Netherlands
State/province [45] 0 0
Amsterdam
Country [46] 0 0
Norway
State/province [46] 0 0
Oslo
Country [47] 0 0
Singapore
State/province [47] 0 0
Singapore
Country [48] 0 0
Spain
State/province [48] 0 0
Andalucia
Country [49] 0 0
Spain
State/province [49] 0 0
Barcelona
Country [50] 0 0
Spain
State/province [50] 0 0
Castilla Y Leon
Country [51] 0 0
Spain
State/province [51] 0 0
Catalunya
Country [52] 0 0
Spain
State/province [52] 0 0
Comunidad Valenciana
Country [53] 0 0
Spain
State/province [53] 0 0
Madrid
Country [54] 0 0
Taiwan
State/province [54] 0 0
Taipei
Country [55] 0 0
United Kingdom
State/province [55] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Pennsylvania
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


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/NCT02445222