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History of Changes for Study: NCT03105336
A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL) (ZUMA-5)
Latest version (submitted February 23, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 3, 2017 None (earliest Version on record)
2 April 19, 2017 Contacts/Locations, Study Status and Study Identification
3 June 2, 2017 Recruitment Status, Study Status, Contacts/Locations and Eligibility
4 June 6, 2017 Contacts/Locations and Study Status
5 July 25, 2017 Contacts/Locations and Study Status
6 September 29, 2017 Contacts/Locations and Study Status
7 October 6, 2017 Contacts/Locations and Study Status
8 November 17, 2017 Contacts/Locations and Study Status
9 December 18, 2017 Contacts/Locations and Study Status
10 March 7, 2018 Study Status and Contacts/Locations
11 March 14, 2018 Contacts/Locations and Study Status
12 March 23, 2018 Arms and Interventions and Study Status
13 April 6, 2018 Arms and Interventions and Study Status
14 April 26, 2018 Contacts/Locations and Study Status
15 April 30, 2018 Contacts/Locations and Study Status
16 May 1, 2018 Contacts/Locations and Study Status
17 May 17, 2018 Contacts/Locations and Study Status
18 June 27, 2018 Contacts/Locations and Study Status
19 July 18, 2018 Outcome Measures and Study Status
20 August 2, 2018 Contacts/Locations and Study Status
21 August 20, 2018 Contacts/Locations and Study Status
22 August 29, 2018 Eligibility and Study Status
23 October 19, 2018 Outcome Measures, Study Status, Arms and Interventions, Contacts/Locations, Study Description, Eligibility, Study Design and Study Identification
24 November 21, 2018 Study Status
25 December 17, 2018 Study Status
26 February 13, 2019 Study Status, Study Identification, IPDSharing and Contacts/Locations
27 March 14, 2019 Study Description, Study Status, Eligibility and Study Design
28 May 21, 2019 Study Status and Contacts/Locations
29 August 30, 2019 Study Status
30 September 20, 2019 Contacts/Locations and Study Status
31 December 10, 2019 Study Status
32 February 5, 2020 Study Status
33 April 8, 2020 Contacts/Locations and Study Status
34 April 10, 2020 Contacts/Locations and Study Status
35 May 7, 2020 Study Status
36 June 17, 2020 Contacts/Locations and Study Status
37 July 9, 2020 Study Status
38 September 3, 2020 Study Status
39 October 1, 2020 Study Status and Outcome Measures
40 November 10, 2020 Study Status
41 December 7, 2020 Study Status
42 January 13, 2021 Contacts/Locations and Study Status
43 January 22, 2021 Contacts/Locations and Study Status
44 February 24, 2021 Contacts/Locations and Study Status
45 March 16, 2021 Study Status
46 May 14, 2021 Contacts/Locations and Study Status
47 June 1, 2021 Contacts/Locations and Study Status
48 August 4, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
49 May 24, 2022 Study Status, References and Study Design
50 November 22, 2022 Study Status
51 April 18, 2023 Arms and Interventions, Outcome Measures, Study Description, Study Status and Eligibility
52 September 15, 2023 Study Status
53 October 25, 2023 Study Status and Study Identification
54 February 23, 2024 Study Status
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Study NCT03105336
Submitted Date:  April 3, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: KTE-C19-105
Brief Title: A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL) (ZUMA-5)
Official Title: A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL)
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2017
Overall Status: Not yet recruiting
Study Start: April 2017
Primary Completion: December 2018 [Anticipated]
Study Completion: July 2023 [Anticipated]
First Submitted: April 3, 2017
First Submitted that
Met QC Criteria:
April 3, 2017
First Posted: April 7, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
April 3, 2017
Last Update Posted: April 7, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Kite, A Gilead Company
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This study will enroll approximately 50 adult subjects who have relapsed or refractory (r/r) iNHL to be infused with the study treatment, axicabtagene ciloleucel, to see if their disease responds to this experimental product and if this product is safe. Axicabtagene ciloleucel is made from the subjects own white blood cells which are genetically modified and grown to fight cancer. An objective response rate of 70% is targeted.
Detailed Description:

This study will enroll approximately 50 adult subjects who have relapsed or refractory (r/r) iNHL to be infused with the study treatment, axicabtagene ciloleucel, to see if their disease responds to this experimental product and if this product is safe. Axicabtagene ciloleucel is made from the subjects own white blood cells which are genetically modified and grown to fight cancer. An objective response rate of 70% is targeted.

All enrolled subjects will be screened for eligibility then will undergo leukapheresis to collect white blood cells for manufacturing. In preparation for the infusion with axicabtagene ciloleucel, subjects will undergo conditioning chemotherapy with cyclophosphamide and fludarabine for 3 days to help the study treatment be effective. After the product is manufactured and conditioning chemotherapy period is complete, subjects will be infused with axicabtagene ciloleucel and then monitored in a hospital for a minimum of 7 days. Subjects will be followed by their study doctor for continued monitoring of the safety and effectiveness of the study treatment for approximately 3 months after receiving treatment and then will be followed for safety for up to an additional 3 ½ years.

Open or close this module Conditions
Conditions: Follicular Lymphoma
Marginal Zone Lymphoma
Indolent Non-Hodgkin Lymphoma
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 50 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: KTE-C19 Biological: KTE-C19
A conditioning chemotherapy regiment of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously.
Other Names:
  • axicabtagene ciloleucel
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Objective response rate
[ Time Frame: 6 months ]

Complete response (CR) + partial response (PR) per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma (Cheson 2007) as determined by the study investigators.
Secondary Outcome Measures:
1. Progression Free Survival
[ Time Frame: 12 months ]

The time from the axicabtagene ciloleucel infusion date to the date of disease progression per the revised IWG Response Criteria for Malignant Lymphoma (Cheson 2007) or death from any cause.
2. Overall Survival
[ Time Frame: 12 months ]

Defined as the time from axicabtagene ciloleucel infusion to the date of death.
3. Incidences of AEs
[ Time Frame: 12 months ]

The frequency of any AEs that occurred during study participation.
4. Clinical significant changes in lab values.
[ Time Frame: 12 months ]

The occurrence of any changes in lab values deemed to be clinically significant during study participation.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • 1) Subject has [follicular lymphoma that has relapsed within 24 months of first diagnosis and treatment with combination chemoimmunotherapy] (e.g. R-bendamustine, R-CHOP) OR Progression of iNHL within 6 months of completion of second or later line therapy containing both an anti-CD20 antibody and alkylating agent OR Progression of iNHL at any point following autologous transplantation.

    2) Subject has [measurable disease].

    3) Subject has no known presence or history of CNS involvement by lymphoma.

    4) If subject is on conventional systemic therapy or systemic inhibitory/stimulatory immune checkpoint therapy, subject is able to stop conventional therapy 2 weeks or 5 half-lives, whichever is shorter, or immune checkpoint therapy 3 half-lives prior to planned leukapheresis.

    5) Subject has ECOG performance status of 0-1 and adequate renal, hepatic, pulmonary, and cardiac function

    6) Subject is not pregnant or breastfeeding (female subjects only) and is willing to use birth control from the time of consent through 6 months following CAR T cell infusion (both male and female subjects).B24

Exclusion Criteria:

  • 1) Transformed FL

    2) Small lymphocytic lymphoma

    3) Histological Grade 3b FL

    4) Subject will have undergone autologous transplant within 6 weeks of planned leukapheresis or has undergone allogeneic transplant.

    5) Subject has evidence of involvement of the heart by lymphoma or requirement for urgent therapy due to ongoing or impending oncologic emergency (e.g. mass effect, tumor lysis syndrome, etc.)

Open or close this module Contacts/Locations
Central Contact Person: Erin Jackson
Email: jacksonerin@prahs.com
Central Contact Backup: Jennifer Lee
Telephone: 424-532-9319
Email: jlee@kitepharma.com
Study Officials: Zachary Roberts, MD, PhD
Study Director
Kite, A Gilead Company
Locations: United States, Florida
H Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
Contact:Contact: Matthew Scott matthew.scott@moffitt.org
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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